The Efficacy and Safety of IBS Digital Behavioral Treatment Study
Phase: NA
Conditions: Irritable Bowel Syndrome
Sponsor: metaMe Health

Confidential 
 
metaMe Health, Inc.  
Protocol 
 
Title 
A Randomized, Double-Blinded, Comparator-Controlled, Parallel-
Group Study to Evaluate the Efficacy and Safety of Self-administered 
Digital Gut-Directed Hypnotherapy for the Treatment of Adult Subjects 
with Symptomatic Irritable Bowel Syndrome  
 
Short Title 
Efficacy and Safety of IBS Digital GDH Treatment (EASITx) 
 
 
Sponsor: 
metaMe Health, Inc. 
222 Merchandise Mart Plaza, Suite 1230 
Chicago, IL 60654 
 
metaMe Protocol Number  
 
MM001 
Investigational Product: 
Gut-directed hypnotherapy (Regulora) 
Version Number: 
6.0 
Version Date 
12-June-2020 
 
 
CONFIDENTIAL PROPERTY OF metaMe HEALTH, INC 
 
This document contains confidential and proprietary information that is property of metaMe 
Health, Inc. Acceptance of this document constitutes the agreement by the recipient that no 
information contained herein will be published or disclosed to any party without written 
authorization from metaMe Health, Inc except to the extent necessary to obtain informed consent 
from the those persons to whom the treatment may be administered. Furthermore, the 
information is only meant for review and compliance by the recipient, his or her staff, and 
applicable institutional review committee and regulatory agencies to enable conduct of the study.  
 
 

 
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1 ADMINISTRATIVE INFORMATION 
1.1 Contacts 
 
Principal Investigator 
Lucy Pun, DO 
Elevated Health 
18800 Delaware Street, Suite 800 
Huntington Beach, CA 92648 
(323) 719-7832 
drpun@elevatedhealth.md  
 
Medical Monitor (for patient safety related issues or questions) 
Dr. William Gannon, MD 
metaMe Health, Inc. 
222 Merchandise Mart Plaza, Suite 1230 
Chicago, IL 60654 
(703) 447-2615 
bill@metamehealth.com 
 
Curebase Study Manager (for study procedural, technical or administrative questions) 
Arsheen Ali 
Curebase, Inc. 
335 S Van Ness Ave 
San Francisco, CA 94103 
(626) 483-9418 
 
 
 

 
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1.2 Approval by representatives of metaMe Health 
 
REPRESENTATIVES OF METAME SIGNATURE PAGE 
 
This study will be conducted with the highest respect for individual subjects in accordance with 
the requirements of this study protocol and in accordance with the following: 
 
● The ethical principles that have their origin in the Declaration of Helsinki. 
● International Council for Harmonisation E6 Good Clinical Practice: Consolidated 
Guideline. 
● United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or 21 CFR Part 812) 
● All applicable laws and regulations, including, without limitation, data privacy laws, 
clinical trial disclosure laws, and regulations. 
 
SIGNATURE 
 
 
 
 
 
David Recker, MD 
 
 
 
 
 
 
Date 
Chief Medical Officer 
metaMe Health, Inc. 
 
 
 
 
 

 
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1.3 Principal Investigator Agreement 
I confirm that I have read and that I understand this protocol and any other product information 
provided by the sponsor. I agree to conduct this study in accordance with the requirements of this 
protocol and to protect the rights, safety, privacy, and well-being of study subjects in accordance 
with the following: 
 
● The ethical principles that have their origin in the Declaration of Helsinki. 
● International Council for Harmonisation, E6 Good Clinical Practice: Consolidated 
Guideline. 
● United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or 21 CFR Part 812). 
● All applicable laws and regulations, including, without limitation, data privacy laws and 
regulations. 
● Regulatory requirements for reporting adverse events defined in Section 9.3 of this 
protocol. 
● I agree to ensure that all associates, colleagues, and employees assisting in the conduct of 
the study are informed about their obligations in meeting the above commitments.  
● I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and 
to make those records available for inspection in accordance with 21 CFR 312.68. 
 
I further authorize that my personal information may be processed and transferred in accordance 
with the uses contemplated in this protocol. 
 
 
 
  
Signature of Principal Investigator   
 
 
 
Date 
 
 
 
Investigator Name (print or type) 
 
 
 
Investigator’s Title 
 
 
 
Location of Facility (City, State/Province) 
 
 
 

 
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1.4 Statement of Compliance 
The study will be carried out in accordance with International Council for Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
● United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or 21 CFR Part 812).  
 
Investigators and clinical study staff who are responsible for the conduct, management, or 
oversight of this clinical trial have completed Human Subjects Protection and ICH GCP Training 
as documented in master trial documents maintained by Curebase, Inc. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled. Any amendment 
to the protocol will require review and approval by the IRB before the changes are implemented 
to the study. In addition, all changes to the consent form will be IRB-approved; a determination 
will be made regarding whether a new consent needs to be obtained from subjects who provided 
consent, using a previously approved consent form. 
 
1.5 Study Reference Information 
 
Study-Related Responsibilities 
The sponsor will perform all study-related activities except for those delegated to Curebase 
(CRO), Jeff Botbyl (biostatistics) and Nandini Murthy (regulatory). These vendors will perform 
these activities in full or in partnership with the sponsor. 
 
Coordinating Investigators 
metaMe will select two Signatory Coordinating Investigators from the investigators who 
participate in the study. Selection criteria for this investigator will include significant knowledge 
of the study protocol, the treatment protocol, expertise in the therapeutic area, and expertise in 
the conduct of clinical research as well as study participation. The Signatory Coordinating 
Investigator will be required to review and sign the clinical study report and by doing so agrees 
that it accurately describes the results of the study. 
 
2 PROTOCOL SUMMARY 
 
2.1 Synopsis 
Title: 
A Randomized, Double-Blinded, Comparator-Controlled, Parallel-Group 
Study to Evaluate the Efficacy and Safety of Self-administered Digital Gut-

 
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Directed Hypnotherapy (GDH) for the Treatment of Adult Subjects with 
Symptomatic Irritable Bowel Syndrome (IBS). 
 
Study Design: 
EASITx is a pivotal study of digital GDH (Regulora), a novel digital 
therapeutic which delivers the North Carolina GDH treatment protocol to 
IBS subjects. EASITx tests the hypothesis that the digital version of the 
North Carolina GDH treatment protocol is safe and, relative to a 
comparator treatment platform, enables a clinically significant reduction in 
abdominal pain intensity and other symptoms of IBS. EASITx is a pivotal 
medical device study, and digital GDH is classified as Software as a 
Medical Device (SaaMD). 
 
The North Carolina GDH treatment protocol consists of 7 unique GDH 
scripts, each approximately 30 minutes in length and a single practice 
session, approximately 13 minutes in length. Each script has been converted 
to a video/audio recording allowing for administration via a mobile device, 
tablet or personal computer, mimicking the frequency and duration of 
therapist-administered GDH.  
 
The EASITx study will apply state-of-the-art IBS and behavioral research 
methodology including use of a fully digital treatment platform, a 
comparator that allows subjects to be blinded to the treatment hypothesis, 
and a data collection (ePRO) system which creates a double blind, 
eliminating the potential for investigator bias. The comparator treatment 
platform will be identical to the GDH treatment platform except that muscle 
relaxation (MR) video/audio recordings equal in treatment duration and 
frequency of administration will be substituted for the GDH video/audio 
recordings. MR was chosen as the control after consultation with the FDA.  
 
The EASITx study is 68 weeks in duration and is composed of 4 distinct 
phases.  
● Phase 1: A 4-week pre-treatment run-in assessment period (weeks 
minus 4 through minus 1) 
● Phase 2: A 12-week treatment period (weeks 1 through 12) 
● Phase 3: A 4-week post-treatment assessment period (weeks 13 
through 16)  
● Phase 4: A 52-week post-treatment long-term extension (LTE) 
during which time subjects will be required to complete two 4-week 

 
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assessment periods starting at 5 months post-treatment (weeks 35 
through 38) and 11 months post-treatment (weeks 61 through 64). 
 
Participation begins with the completion of an online prescreening 
eligibility survey via Curebase, a clinical research software platform. 
Subjects who pass prescreening will be consented online and scheduled for 
a baseline visit with a study physician. At this visit, their IBS diagnosis will 
be confirmed, inclusion and exclusion criteria will be applied, and subject-
facing surveys administered. Subjects will be trained on the use of the 
electronic patient reported outcomes tool (ePRO) and daily collection of 
IBS pain and stool symptoms.  
 
The Phase 1 period will begin the day after the baseline visit. The Phase 1 
4-week run-in period is a baseline symptom assessment period during 
which time subjects will enter their IBS symptoms daily and record them 
digitally via the Curebase ePRO on their mobile phone, tablet, or personal 
computer. This run-in period will provide baseline symptom data for 
comparison to post-treatment data collected in Phases 3 and 4. The Phase 1 
run-in symptom data is also used to determine whether subjects are 
committed to participation by assessing their ability to consistently and 
accurately input data into the ePRO, and also establishes that subjects have 
the minimally required level of IBS symptom severity. 
 
Once the run-in is completed, ineligible subjects will be informed, and 
eligible subjects will receive an “Onboarding Call” from a member of the 
Curebase study staff. The Onboarding Call will occur as soon as possible 
after the Phase 1 run-in period (at least 1 day but not more than 14 days). 
This call will be used to inform subjects of eligibility, confirm participation, 
create a user account, confirm access to the platform, and provide training 
on the use of the metaMe treatment platform. During the Onboarding call, 
subjects will select a treatment day and time that is maintained throughout 
treatment (Phase 2). Phase 2 will start on the next occurrence of the chosen 
weekday. Subjects will be randomized 1:1 into the 2 treatment groups by a 
firewalled Curebase staff member who will enter the treatment group 
assignment on the metaMe platform. A software switch will directly initiate 
the assigned treatment allocation.  
 
The study is double-blinded, which in the context of EASITx means that 
subjects will not be aware of which treatment (GDH or the comparator) is 

 
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being evaluated, and at the same time the metaMe staff and investigators 
will not have knowledge of group assignments (see Section 7.2.1). Subjects 
will complete treatment, per their group assignment and all subsequent data 
collection will be done without human intervention via the Curebase 
platform.  
 
The Phase 2 treatment period will initiate within 7 days of the onboarding 
call. Phase 2 will be initiated with the first treatment session followed by 6 
additional treatment sessions occurring every 2 weeks for a total of 
7 sessions over 12 weeks. Subjects will receive prompts to complete a short 
practice sessions on the 5th, 8th, and 11th day between treatments. Practice 
sessions are recommended but not required.  
 
Phase 3 begins immediately after completion of Phase 2 treatment period. 
Subjects will provide 4 weeks of post-treatment symptom data via the 
ePRO and the Curebase platform. Symptoms reported in this run-out period 
will be used to determine the primary outcome and responder definition and 
secondary outcomes. 
 
Phase 4 begins immediately after completion of Phase 3. Subjects will 
complete two post-treatment assessment periods and provide daily 
symptom assessments and additional instances of outcomes surveys via the 
ePRO and the Curebase platform. The LTE 4-week assessment periods are 
weeks 35 through 38 and weeks 61 through 64.  
 
Compliance with treatment and data entry will be facilitated by email and 
text message reminders and prompts. Each subject will be compensated for 
participation and data collection based on a pre-defined schedule with a 
maximal milestone determined compensation of $525 (Section 5.5).  
 
ePRO symptom data and outcomes surveys will be collected according to a 
pre-defined schedule (Table 1). 
Objectives: 
Primary Objective 
The primary objective of this study is to demonstrate that in adults 
with Irritable Bowel Syndrome (IBS), an all-digital Gut-Directed 
Hypnotherapy (GDH) treatment program (Regulora) is superior in 
reducing abdominal pain intensity relative to an all-digital modified 
Jacobsonian Muscle Relaxation (MR) treatment program. 

 
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Secondary Objectives 
● To demonstrate that Regulora has a positive impact on relief of IBS 
symptoms, quality of life, workplace performance (presenteeism 
and absenteeism), and psychological distress relative to MR therapy. 
● To determine the durability of Regulora in relief of IBS symptoms, 
quality of life, workplace performance (presenteeism and 
absenteeism), and psychological distress relative to MR therapy. 
 
Exploratory Objective 
The exploratory objective of this study is to investigate predictors of 
treatment success using the PHQ-4 and Thought Impact Scale (TIS). 
Endpoints: 
Primary Endpoint: The primary endpoint of this study is abdominal pain 
intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 
10= worst pain). The subject is asked to record their “worst abdominal pain 
over the past 24-hours”. An Abdominal Pain Intensity Responder is 
defined as a subject whose daily abdominal pain intensity averaged over the 
4 weeks of Phase 3 (weeks 13 through 16) is 30% reduced compared to the 
daily abdominal pain intensity averaged over the 4 weeks of Phase 1 (weeks 
-4 through -1). 
 
Secondary Efficacy Endpoints: The secondary efficacy endpoints of this 
study include: 
● Overall mean change from Phase 1 to Phase 3 and Phase 1 to Phase 
4 (LTE) in: 
o Abdominal pain intensity 
o Abdominal pain frequency 
o Irritable Bowel Syndrome-Quality of Life questionnaire 
(IBS-QOL) 
o Daily stool consistency (IBS-D and IBS-M) 
o Daily stool frequency (IBS-C) 
o Workplace Productivity and Activity Impairment 
questionnaire (WPAI) 
● 12-week trends during Phase 2 in: 
o Abdominal pain intensity 
o Abdominal pain frequency 
o Daily stool consistency 

 
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o Daily stool frequency  
 
Secondary Safety Endpoints: Safety and tolerability will be evaluated by 
comparing adverse events in the treatment arm versus comparator arm. 
 
Exploratory Endpoints: 
● Prediction of treatment success using the North Carolina Thought 
Impact Scale (TIS)  
● Prediction of treatment success using the PHQ-4 
● Treatment adherence (number of sessions completed) 
● Concomitant IBS Medication 
● Blinding Assessment 
● Satisfaction questions 
● IBS-Adequate relief (IBS-AR) 
 
Study 
Population: 
Subjects will include men and women of all ethnic and racial groups 
between 18 and 70 years of age. They must meet Rome IV Diagnostic 
Criteria (3) for IBS as established by a licensed physician. 
 
Number of 
Subjects: 
To meet the goal of 380 randomized subjects and 300 evaluable subjects 
(estimated maximum 20% study dropout rate) we will recruit patients from 
study physician clinic populations (physicians will be authorized to screen 
their own subject population for eligibility) and subjects who have been 
recruited and prescreened via online, digital channels. We estimate needing 
to pre-screen several thousand subjects to recruit 760 for enrollment in 
Phase 1 (baseline assessment and eligibility screening). We expect ~50% 
will fail eligibility screening (see Sec. 6.2 Inclusion Criteria) providing a 
minimum of 380 subjects for phase 2 (treatment). 
 
Inclusion 
Criteria: 
To be eligible to participate in this study, an individual must meet all of the 
following criteria, which are assessed at the Baseline Screening event: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and 
availability for the duration of the study 
3. Male or female, aged 18-70 
4. Confirmation of the IBS and IBS subtype diagnosis by a study 
physician using Rome IV diagnostic criteria (see Appendix A) 
5. Possess iOS or Android smartphone or iOS tablet (iPad) released in 
2015 or later. 

 
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6. Agreement to input information about their abdominal pain and 
bowel movements on a daily basis into Curebase software 
7. Agreement to have their anonymized data stored in the cloud for up 
to 2 years after the conclusion of the study, and to have the data 
used for research purposes. 
8. Agreement to maintain stable dosage of IBS medications during the 
course of treatment and not to add new IBS medication or stop 
current IBS medications unless directed to do so by the subjects 
treating physician. Changes in treatment will be captured using a 
concomitant medication assessment. 
 
At the Day 0 Screening event, subjects must also meet all of the following 
criteria: 
1. Average “Worst Daily Pain Severity” of >3 on a 11-point numeric 
rating scale (NRS) over the full 28-day symptom tracking period 
2. Consistent submission of Pain Severity scores via the Curebase app 
(data submitted on 70% or more of days in the symptom tracking 
window) 
 
Exclusion 
Criteria: 
An individual who meets any of the following criteria will be excluded 
from participation in this study: 
1. Evidence of current structural intestinal abnormalities that better 
explain the subject’s IBS symptoms (e.g., celiac disease, 
inflammatory bowel disease – Crohn’s Disease and ulcerative 
colitis, prior abdominal surgeries such as weight loss surgery or 
bowel resection)  
2. Medication use, other illnesses or conditions that can explain their 
gastrointestinal symptoms e.g., regular narcotic use or dependency, 
OTC stimulant laxative dependence (e.g., progressively larger doses 
of senna or bisacodyl containing compounds are needed to produce 
a bowel movement), radiation to the abdomen.  
3. Diagnosed and/or treated for a malignancy within the past 5 years 
(other than localized basal or squamous cell carcinomas of the skin)  
4. Current psychotherapy, hypnotherapy, or cognitive behavioral 
therapy (CBT) for IBS 
5. Inability to commit to completing all treatment sessions 
6. Have an unstable extraintestinal condition whose immediate or 
foreseeable treatment needs would realistically interfere with study 
demands, e.g., ability to participate in online treatment sessions or 
follow daily diary. 
7. Active: post-traumatic stress disorder, depression associated with 
high risk of suicidal behavior, psychotic or delusional disorders, 

 
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dissociative disorders, or gross cognitive impairment. This 
exclusion does not apply to anxiety or bipolar disorder 
8. Subjects that report a current gastrointestinal infection or an 
infection within the 4 weeks prior to the evaluation that would 
otherwise obscure IBS symptoms. In cases of gastrointestinal 
infection baseline evaluation will be delayed a minimum of 4 weeks 
until after complete recovery.  
9. Current or recent use of a gut-targeted antibiotic such as Neomycin 
or Rifaximin during the 12 weeks prior to baseline assessment. In 
the case of treatment with rifaximin or neomycin, eligibility will be 
suspended for 12 weeks from the initial date of use. 
10. Any condition that an investigator feels may interfere with the 
conduct of the study 
 
Description of 
Facilities 
Enrolling 
Subjects: 
The EASITx study intends to recruit a highly diverse subject population. To 
reach these subjects, geographically diverse clinics across no fewer than 10 
U.S. states will be enlisted as well as the option for remote virtual study 
participation. Study physicians will include office-based primary care 
physicians (PCPs) and community-based gastroenterologists. All study staff 
will be trained in Good Clinical Practice, the EASITx study protocol and 
the use of Curebase (clinical research software). 
 
Description of 
Study 
Intervention: 
The metaMe Health digital GDH treatment (Regulora) is an IBS-specific 
treatment for use on a smartphone, tablet, or personal computer. The GDH 
treatment module was adapted from a standardized scripted therapist-
administered GDH protocol referred to as the North Carolina Protocol. The 
North Carolina protocol was developed by Dr. Olafur Palsson at the 
University of North Carolina and has been used for over 20 years as a 
therapist administered treatment. metaMe health has licensed the protocol 
from the inventor for exclusive use through any electronic means.  
 
Duration of 
Treatment: 
12 weeks 
Period of 
Evaluation: 
Total of 28 weeks of active evaluation: Phase 1 (4 weeks of run-in 
assessment), Phase 2 (12 weeks of treatment and assessment), Phase 3 
(4 weeks of run-out assessment), Phase 4 (two 4-week follow-up 
assessments at weeks 35-38 and weeks 61-64). 
 
Subject 
Duration: 
68 weeks  

 
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Statistical 
Analyses: 
Primary Endpoints 
The primary endpoint, proportion of overall pain intensity responders, will 
be compared between the GDH and MR treatment groups using a Cochran-
Mantel-Haenszel test adjusted for IBS subtype and gender. Safety will be 
summarized using descriptive statistics. 
 
Secondary Endpoints 
Average abdominal pain frequency and average abdominal pain intensity at 
Week 13-16 will be statistically compared between GDH and MR using an 
ANOVA model adjusted for gender and IBS subtype. The least squares 
(LS) mean estimate of average abdominal pain intensity and LS mean 
difference and associated 95% CIs will be presented with corresponding p-
value. 
 
Additionally, change from baseline and at-assessment values of average 
abdominal pain frequency and average abdominal pain intensity will be 
analyzed at all 4-week assessment time periods with a mixed effects 
repeated measures model (MMRM). 
 
Average abdominal pain frequency and average abdominal pain intensity 
will be summarized descriptively by treatment and time period. 
 
Stool consistency response will be analyzed with methods similar to those 
used to assess the primary endpoint, as described in the Statistical Analysis 
Plan.  
 
IBS-QOL, WPAI, PHQ-4 will be analyzed with MMRM and summarized 
descriptively by treatment and week.  
 
See the Statistical Analysis Plan for details regarding all analyses.  
 
Sample Size Justification 
In this study, a total of approximately 380 subjects will be randomized in a 
1:1 ratio to GDH or comparator to ensure that at least 300 subjects 
complete their Week 13-16 assessment (Phase 3) for analysis. Three 
hundred (300) Phase 3 completers will provide at least 90% power to detect 
an 18 percentage point difference in response rates between the GDH and 
comparator treatment groups at the 5% significance level. The study was 
powered assuming that the comparator treatment group is expected to 

 
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demonstrate at most a 26% response rate. To determine the expected 
response rate in the comparator treatment group, two studies of GDH 
reporting data that utilized dichotomous outcome measures were examined. 
The first (9) used an endpoint of % treatment responders (defined as a 
>50% reduction in IBS-SSS). In this study, 52% of subjects in the GDH 
group and 26% of subjects in the control group (usual care) were 
responders. In a more recent study by Flik et al (11) these authors reported 
an adequate relief response rate of 40% in the GDH group compared to 
17% in the education-control group. We therefore have assumed that the 
response rate in the comparator treatment group in this study is likely to be 
between 17-26%. 
 

 
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2.2 Schema 
The study schema can be found in Figure 1, indicating the flow of actions. The blue flow 
elements correspond to time points in the Schedule of Activities (SoA) presented in Table 1. 
 
Figure 1 
Study Schema 
 
Abbreviations: GDH=gut-directed hypnotherapy; IBS=irritable bowel syndrome; LTE=long-term extension; 
QOL=quality of life. 
 
 

 
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2.3 Schedule of Activities 
The complete schedule of study activities, often referred to as a “Time and Events” (T+E) table, 
is presented in Table 1. Please observe the following when interpreting it: 
● The Phase 1 run-in period will start the day after the Baseline Visit. 
● The Onboarding Call will occur as soon as possible (at least 1 day but not more than 14 
days) after the Phase 1 run-in period. The call will take place on the next mutually 
agreeable non-holiday weekday.  
● Randomization occurs on the day of the Onboarding call, which we define as “Day 0” in 
our framework. 
● Phase 2 (treatment) will begin no more than 7 days after the Onboarding call. 
● As part of ensuring the above schedule of activities are completed in a timely manner and 
in accordance with the protocol, the study team shall utilize phone call, email, and text-
based reminders sent to the study subjects. 
 
Please refer to Section 8 for a detailed description of assessments described in Table 1. 

 
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Online 
Screeni
ng 
Baseline 
Visit 
Run-In 
Period 
(weeks -
4 to -1) 
Onboard
ing Call 
day 0 
Treatment 
Period 
(weeks 1-
12) 
Run-
Out 
Period 
(weeks 
13-16) 
LTE 1: 
(weeks 
35-38) 
LTE 2:  
(weeks 
61-64) 
Informed 
Consent 
X 
 
 
 
 
 
 
 
Diagnosis 
(Rome IV) 
 
X 
 
 
 
 
 
 
Inclusion 
Exclusion 
Criteria 
 
X 
 
 
 
 
 
 
Abdominal 
Pain Severity 
 
 
Daily 
 
Daily 
Daily 
Daily 
Daily 
Randomizatio
n 
 
 
 
X 
 
 
 
 
Screening & 
Onboarding 
 
 
 
X 
 
 
 
 
Treatment 
Adherence 
Data (Wistia) 
 
 
 
 
Continuous 
import 
 
 
 
Stool 
Consistency 
 
 
Daily 
 
Daily 
Daily 
Daily 
Daily 
Stool 
Frequency 
 
 
Daily 
 
Daily 
Daily 
Daily 
Daily 
Adverse Event 
Reports 
 
 
X 
X 
X 
X 
X 
X 
IBS QOL 
 
X  
 
 
Once at 
week 16 
Once at 
week 38 
Once at 
week 64 
TIS 
 
X 
 
 
 
 
 
WPAI 
 
X  
 
Once at 
week 8 
Once at 
week 16 
Once at 
week 38 
Once at 
week 64 
Concomitant 
medication 
assessment 
 
X 
(checked 
 
 
Once at 
week 8 
Once at 
week 16 
Once at 
week 38 
Once at 
week 64 

 
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by 
physician) 
PHQ-4 
 
X  
 
 
Once at 
week 16 
Once at 
week 38 
Once at 
week 64 
Satisfaction 
Survey 
 
 
 
 
 
Once at 
week 16 
 
 
Blinding 
assessment 
 
 
 
 
 
Once at 
week 16 
 
 
 
Table 1 
Schedule of Activities 
 
Abbreviations: IBS QOL=Irritable Bowel Syndrome Quality of Life Questionnaire; LTE=long-term extension; 
PHQ-4=Patient Health Questionnaire-4; TIS=North Carolina Thought Impact Scale; WPAI =Workplace 
Productivity and Activity Impairment Questionnaire. 
Participants are asked to complete their Baseline Surveys within 7 days of enrollment, which include IBS 
QOL, PHQ4, TIS, and WPAI.  
 
 

 
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TABLE OF CONTENTS 
 
1 
ADMINISTRATIVE INFORMATION 
 
1.1 
Contacts 
2 
1.2 
Approval by Representatives of metaMe Health 
3 
1.3 
Investigator Agreement 
4 
1.4 
Statement of Compliance 
5 
1.5 
       Study Reference Information 
 
 
 
 
 
           5 
2 
53 
273.1 
283.2 
283.3 
293.3.1 293.3.2 303.3.3 304 
314.1 
324.1.1 324.1.2 324.1.3
 
324.2 
324.2.1 324.2.2 324.2.3 335 
335.1 
345.2 
365.2.1 365.2.2 365.2.3 365.3 
365.3.1
 
366 
366.1 
366.2 
376.3 
386.4 
396.5 
397 
407.1 
407.1.1 407.2 
447.2.1 447.2.2
 
457.2.3 467.3 
467.4 
478 
478.1 
488.2 
488.3 
499 
499.1 
509.1.1 519.1.2 519.1.3
 
519.1.4 519.1.5 519.1.6 519.1.7 519.1.8 529.2 
529.2.1 529.2.2 539.3 
539.3.1 539.3.2 549.3.3
 
559.3.3.1 
559.3.3.2 
559.3.3.3 
569.3.3.4 
569.3.3.5 
569.3.3.6
 
579.3.4 579.3.5 5710.1 5910.2 5910.3 6010.4 6010.4.1 6010.4.2 6110.4.3 6110.4.3.1
 
6110.4.3.2 
6210.4.3.3 
6210.4.3.4 
6310.4.3.5 
6410.4.3.6 
6410.4.4 6410.4.5
 
6510.4.6 6510.4.7 6510.4.8 6511 
6511.1 6611.1.1 6611.1.2 6711.1.3 6711.1.4 6711.1.5 6811.1.6
 
6811.1.6.1 
6911.1.6.2 
6911.1.6.3 
7011.1.6.4 
7011.1.6.5 
7111.1.6.6
 
7111.1.6.7 
7211.1.6.8 
7212 
72 

 
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LIST OF TABLES 
Table 1 
176 
 

 
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LIST OF FIGURES 
Figure 1 
15Figure 2 
37Figure 
3 
449 
 
 

 
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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition or Term 
AE 
adverse event 
BSFS 
Bristol Stool Form Scale 
CBT 
cognitive behavioral therapy 
CI 
confidence interval 
CONSORT 
Consolidated Standards of Reporting Trials 
eCRF 
electronic case report form 
Enrolled 
ePRO 
A participant is enrolled when he/she signs the informed consent. 
electronic patient-reported outcome 
FGID 
functional gastrointestinal disorder 
GCP 
Good Clinical Practice 
GDH 
gut-directed hypnotherapy 
GEE 
generalized estimating equations 
HIPAA 
Health Insurance Portability and Accountability Act 
IBS 
irritable bowel syndrome 
IBS-QOL 
Irritable Bowel Syndrome Quality of Life questionnaire 
ICH 
International Council for Harmonisation 
ITT 
Intent-to-Treat 
LS 
least squares 
LTE 
long-term extension 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
mixed effects repeated measures 
NRS 
numeric rating scale 
Participant 
PHQ-4 
Synonymous with “Subject”.  
Patient Health Questionnaire-4 
PP 
Per Protocol 
PRO 
patient-reported outcome 
Randomized 
 
Regulora 
SaaMD 
A participant is randomized when he/she is assigned to the Regulora 
or comparator arm of the study. 
metaMe Health’s implementation of all-digital GDH for IBS. 
Software as a Medical Device 
SAE 
serious adverse event 
SADE 
SUADE 
SAP 
serious adverse device effect 
serious unanticipated adverse device effect 
statistical analysis plan 
SoA 
schedule of activities 
SOC 
System Organ Class 
SOP 
standard operating procedures 
Subject 
 
TIS 
A person who has interacted with the EASITx study as a potential 
participant. A subject may or may not be enrolled or randomized.  
North Carolina Thought Impact Scale 

 
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WPAI 
Workplace Productivity and Activity Impairment questionnaire 

 
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3  INTRODUCTION 
3.1 Background 
Irritable Bowel Syndrome (IBS) is the most common functional gastrointestinal disorder (FGID), 
affecting approximately 10% of the US adult population (1). IBS is characterized by abdominal 
pain that is often severe and with an onset that is unpredictable. Episodes of pain are associated 
with altered bowel habits, which define the three main subtypes: IBS-constipation (IBS-C), IBS-
diarrhea (IBS-D), and IBS-mixed (IBS-M). A fourth subtype, IBS-undefined (IBS-U), occurs in 
<5% of IBS patients and defines a group of subjects who do not fall into the 3 diagnostic 
subtypes but are still considered to have IBS (2). IBS has significant effects on quality of life, 
work performance (presenteeism), and work attendance (absenteeism) (3,4,5). 
 
IBS is often referred to as a functional disease because X-ray studies, blood tests, and intestinal 
endoscopy exams are normal. However, upon careful analysis, IBS patients have an increased 
likelihood of hypersensitive visceral sensory nerve function, abnormalities in the gut 
microbiome, and central pain processing. These are important components of the bidirectional 
brain-gut control pathway referred to as the brain-gut axis, which is dysfunctional in IBS patients 
(6). IBS is associated with a number of co-morbid psychological disorders (somatization, 
catastrophization, depression, stress, and anxiety) that place an additional strain on subjects and 
further affect the function of the brain-gut axis (7). 
 
The treatment of IBS has traditionally included recommendations for dietary changes and over-
the-counter medicines, which have modest to no effect on symptoms and do not change the 
course of the disease. Pharmaceutical drug development has tended to focus on druggable 
molecular targets that for the most part are not implicated in the pathophysiology of the 
syndrome but that allow for pharmacologic manipulation of intestinal symptoms. The current 
class of IBS medicines all work locally within the gut and fail to address the psychological 
drivers of IBS and the alterations in the brain-gut axis. Moreover, in clinical studies and medical 
practice these drugs have significant side-effects and are marginally effective at best for the 
treatment of the full constellation of IBS symptoms, particularly abdominal pain (8). In contrast 
to the modest efficacy observed with pharmaceuticals, non-pharmacologic behavioral treatments 
that target the psycho-social co-morbidities and brain-gut axis dysfunction have shown high rates 
of treatment response (discussed below). 
 
3.2 Study Rationale 
Gut-directed hypnotherapy (GDH) is a form of hypnotherapy that is tailored to address the 
symptoms of IBS. There is a growing body of evidence demonstrating the usefulness of 
hypnotherapy for a wide range of conditions (9). Recent large randomized controlled trials have 
demonstrated that therapist-administered GDH is effective for the treatment of IBS with 
enduring effects on both abdominal pain and gut symptoms (10,11,12). Nevertheless, widespread 

 
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use of GDH has been limited despite strong support from gastroenterology professional 
organizations (13). The reasons for the limited use stem largely from a lack of physician training 
in hypnotherapy, a limited number of trained hypnotherapists and a limited number of 
hypnotherapy training programs (14). There is also the issue of therapist fatigue which occurs 
after repeated administration of the scripted protocol. 
 
The body of scientific evidence supporting the efficacy of GDH in IBS is derived from over 
20 studies of therapist-administered GDH, with a reported 50% reduction in gastrointestinal 
symptom severity and abdominal pain severity (reviewed in 10). The efficacy of GDH in the 
treatment of IBS has been recently confirmed in a large multicenter randomized controlled trial 
that examined a standardized GDH protocol, administered either in individual sessions or in 
group sessions, and compared to an IBS education control (12). At one-year post treatment, 41% 
of subjects in the individual therapy and 50% of subjects in the group therapy met the primary 
endpoint of adequate relief of symptoms compared to 23% of subjects in the control group. GDH 
was statistically superior to control in both the individual and group hypnotherapy groups 
demonstrating the flexibility of GDH treatment across treatment environments.  
 
In long-term follow-up studies, GDH has shown sustained effectiveness for up to 5 years after a 
single course of treatment (15). Recent advances in neuroscience and neuroimaging have 
provided tools needed to unravel the complex central nervous system effects of hypnosis (9). It 
has been suggested that the mechanisms responsible for hypnotherapy-induced improvements in 
chronic pain, anxiety and mood arise from hypnotic induction and a re-focusing of attention 
away from the immediate environment towards an imaginative involvement. The use of 
metaphor, parable and story is used to communicate imagery, direct messages, and indirect 
messages that facilitate the reprograming of the subliminal function of the unconscious mind. In 
other words, since most people with IBS are vigilant and focused on their symptoms, 
communicating with the unconscious brain entails getting the conscious brain to allow direct 
dialogue with the subconscious brain, the critical manager of automatic functions such as pain 
perception. Hypnotherapy provides a hypothetical mechanism for linking the conscious with the 
unconscious, which in turn facilitates cognitive restructuring, changes in automatic functions 
involved in gut function and amelioration of associated psychosocial disorders. Data from a 
controlled study measuring fMRI signals in IBS patients pre and post-GDH supports this theory 
and demonstrates that GDH results in normalization of brain activation and fMRI signals, 
supporting a role for GDH above and beyond improvements in mood (16).  
 
3.3 Risk/Benefit Assessment 
3.3.1 Known Potential Risks  
Hypnotherapy is generally considered to be safe and low risk. Safety concerns have been 
proposed based on the observation that subjects with dissociative disorders (i.e., multiple 

 
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personality disorder) have an enhanced hypnotizability and under hypnosis may adopt an 
alternate identity or personality state (17-19). Elicitation of an alternate personality state and/or 
repressed memories, which are often past traumatic events, can be a painful experience for 
subjects. At the same time, it is important to note that hypnosis is used to treat dissociative 
disorder and the closely related syndrome of post-traumatic stress disorder (20). Therefore, the 
standard approach to minimizing the risk in hypnotherapy studies requires exclusion of subjects 
with these psychiatric conditions. In a review examining data from 7 hypnotherapy trials on 
ClinicalTrials.gov, it was found that studies that use these exclusion criteria had low rates of 
treatment-related adverse events (AEs) (<1% non-serious AEs) and no serious adverse events 
(SAEs) (20). Of the treatment-related AEs, there were 2 cases of disturbing images and thoughts 
and 2 cases of nightmares. A recent large European study confirmed these results: in 300 
subjects allocated to therapist-administered GDH there were no SAEs or AEs that were deemed 
related to treatment (12).  
 
It is also believed that the hypnotizability of subjects with active co-morbid psychiatric/mood 
disorders may be diminished and available literature indicates that subjects with these conditions 
should generally be excluded from clinical trials.  
 
Finally, there are anecdotal therapist reports of mild headache, lightheadedness and 
disorientation that tend to spontaneously resolve within a short period after post-hypnotherapy 
arousal. As a precaution, subjects will be told to find a quiet place to view the treatment sessions 
and not to undergo treatment while driving or performing other tasks.  
 
3.3.2 Known Potential Benefits  
Digital GDH and MR have not been studied and the potential benefits can only be derived from 
studies and subject reports after therapist-administration.  
 
3.3.3 Assessment of Potential Risks and Benefits  
The risks of this study are minimal. The primary risks include: 
● Possible temporary discomfort from answering personal questions regarding subject 
health. 
● The possibility that subjects may not experience substantial reduction of symptoms or 
those symptoms may worsen. 
● The possibility that subjects may feel sleepy or drowsy for a short while after treatment 
● The possibility that subject muscles may feel tight or ache for a short while after 
treatment. 
 

 
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If subject IBS symptoms were to change or worsen, subjects may call Curebase or seek advice 
from the study physician. The staff of Curebase and study physicians will be closely supervised 
by the Principal Investigator, Dr. Lucy Pun.  
 
The secondary risks include answering symptom survey questions on a daily basis for 7 total 
months, which may seem burdensome. On the other hand, some volunteers find recording daily 
symptoms useful and informative. 
 
Potential benefits include: 
● Free evaluation of IBS from health care professionals.  
● Free treatment for IBS. 
● Possibility of reduction in the frequency, duration, and severity of IBS and related 
problems. 
● Relaxation and a sense of well-being 

 
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4 OBJECTIVES AND ENDPOINTS 
4.1 Study Objectives 
4.1.1 Primary Objective 
The primary objective of this study is to demonstrate that in adults with Irritable Bowel 
Syndrome (IBS), an all-digital Gut-Directed Hypnotherapy (GDH) treatment program 
(Regulora) is superior in reducing abdominal pain intensity relative to an all-digital 
modified Jacobsonian Muscle Relaxation (MR) treatment program. 
 
4.1.2 Secondary Objective 
The secondary objectives of this study are: 
● To demonstrate that Regulora has a positive impact on relief of IBS symptoms, quality of 
life, workplace performance (presenteeism and absenteeism), and psychological distress 
relative to MR therapy. 
●  To determine the durability of Regulora in relief of IBS symptoms, quality of life, 
workplace performance (presenteeism and absenteeism), and psychological distress 
relative to MR therapy. 
 
4.1.3 Exploratory Objective 
The exploratory objective of this study is to investigate predictors of treatment success 
using the PHQ-4 and Thought Impact Scale (TIS). 
 
4.2 Study Endpoints 
For details on assessments and analyses, refer to Section 9 and Section 10, respectively. 
 
4.2.1 Primary Endpoint 
The primary endpoint of this study is abdominal pain intensity. The Instrument is a 11-point 
numeric rating scale (0= no pain, 10= worst pain). The subject is asked to record their “worst 
abdominal pain over the past 24-hours”. An Abdominal Pain Intensity Responder is defined as a 
subject whose daily abdominal pain intensity averaged over the 4 weeks of Phase 3 (weeks 13 
through 16) is 30% reduced compared to the daily abdominal pain intensity averaged over the 4 
weeks of the Phase 1 (weeks -4 through -1). 
 
4.2.2 Secondary Endpoints 
The secondary efficacy endpoints of this study include: 
● Overall mean change from Phase 1 to Phase 3 and Phase 1 to Phase 4 (LTE) in: 

 
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o Abdominal pain intensity 
o Abdominal pain frequency 
o Irritable Bowel Syndrome-Quality of Life questionnaire (IBS-QOL) 
o Daily stool consistency (IBS-D and IBS-M) 
o Daily stool frequency (IBS-C) 
o Workplace Productivity and Activity Impairment questionnaire (WPAI) 
● 12-week trends during Phase 2 in: 
o Abdominal pain intensity 
o Abdominal pain frequency 
o Daily stool consistency 
o Daily stool frequency  
 
Safety and tolerability will be evaluated by comparing adverse events in the treatment arm versus 
comparator arm. 
 
4.2.3 Exploratory Endpoints 
The exploratory Endpoints of this study are: 
● Prediction of treatment success using the North Carolina Thought Impact Scale (TIS) 
(23)  
● Prediction of treatment success using the PHQ-4 (24) 
● Treatment adherence (number of sessions completed) 
● Concomitant IBS Medication 
● Blinding Assessment (25) 
● Satisfaction questions 
● IBS-Adequate relief (IBS-AR) 
 

 
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5 STUDY DESIGN 
5.1 Overall Design 
EASITx is a pivotal study of digital GDH (Regulora), a novel digital therapeutic that delivers the 
North Carolina GDH treatment protocol to IBS subjects. EASITx tests the hypothesis that the 
digital version of the North Carolina GDH treatment protocol is safe and, relative to a 
comparator treatment platform, enables a clinically significant reduction in abdominal pain 
intensity and other symptoms of IBS. EASITx is a pivotal medical device study, and digital 
GDH is classified as Software as a Medical Device (SaaMD).  
 
The North Carolina GDH treatment protocol consists of 7 unique GDH scripts, each 
approximately 30 minutes in length and a single practice session, approximately 13 minutes in 
length. Each script has been converted to a video/audio recording allowing for administration via 
a mobile device, tablet, or personal computer, mimicking the frequency and duration of 
administration of therapist-administered GDH. 
 
The EASITx study will apply state-of-the-art IBS and behavioral research methodology 
including use of a fully digital treatment platform, a comparator allowing for subject-blinding to 
treatment hypothesis, and a data collection (ePRO) system that allows for a double blind, 
eliminating the potential for investigator bias. The comparator-treatment platform will be 
identical to the GDH treatment platform, except that muscle relaxation (MR) audio recordings 
equal in treatment duration and frequency of administration will be substituted for the GDH 
video/audio recordings. MR was chosen as the control after consultation with the FDA.  
 
Participation in the EASITx study will last 68 weeks and is divided into 4 phases:  
● Phase 1: A 4-week pre-treatment run-in assessment period (weeks -4 through -1) 
● Phase 2: A 12-week treatment period (weeks 1 through 12) 
● Phase 3: A 4-week post-treatment assessment period (weeks 13 through 16)  
● Phase 4: A 52-week post-treatment long term extension (LTE) during which time 
subjects will be required to complete two 4-week assessment periods starting 5 months 
post-treatment (weeks 35 through 38) and 11 months post-treatment (weeks 61 through 
64). 
 
Participation begins with the completion of an online prescreening eligibility survey via 
Curebase, a clinical research software platform, followed by an online informed consent. 
Subjects who pass prescreening and sign the informed consent will attend a baseline visit with a 
study physician. At this visit, their IBS diagnosis will be confirmed, inclusion and exclusion 
criteria will be applied, and experimental baseline endpoints will be collected in the form of 
subject-facing surveys. 
 

 
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After the baseline visit, subjects will enter Phase 1 a 4-week run-in period. During Phase 1, 
subjects will assess their IBS symptoms daily and record them digitally via the Curebase ePRO 
from their mobile phone, tablet device, or personal computer. This run-in period will establish 
that subjects are committed to participation (by assessing their ability to consistently and 
accurately input data into Curebase), and also establish that they have the minimally required 
level of IBS symptom severity. 
 
Once the run-in is completed, ineligible subjects will be informed. Eligible subjects will receive 
an “Onboarding Call” from a member of the Curebase study staff. This call will be used to 
inform subjects of eligibility, create a user account on the EASITx treatment website. Subjects 
will be randomized 1:1 into 2 groups in a double-blind scheme, in which only the Curebase Staff 
member is aware of the group assignment. This staff member will enter the treatment group 
assignment on the metaMe platform and ensures that the correct treatment allocation is initiated. 
 
In the EASITx randomization scheme, subjects will either receive the digital GDH intervention 
or the muscle relaxation therapy delivered through the same digital delivery platform 
(comparator treatment arm). As described in Section 7.2, the study is double-blinded such that 
subjects, metaMe staff, and investigators will have no knowledge of group assignments (see 
designated firewalled exceptions in Section 7.2). Participants will complete treatment per their 
group assignment over the course of 12 weeks and track their symptoms daily via Curebase. All 
study activities may be fully remote and can be completed from home. The baseline visit may be 
conducted in-person per the participant’s preference. 
 
The Phase 2 treatment period will include 7 unique sessions (GDH or MR) of ~30 minutes each, 
every other week over the 12-week treatment period. During treatment, a practice session (GDH 
or MR) will be made available to the subjects, with an email encouraging completion of practice 
on the 5th, 8th, and 11th day between treatment sessions. Subjects will be required to complete 
assessments according to the schedule in Table 1.  
 
Data collected in the Phase 3 post-treatment assessment period (run-out period) and the Phase 4 
LTE will be compared to data collected in the Phase 1 pre-treatment assessment period (run-in 
period). Subjects will complete daily symptom assessments and additional instances of the 
concomitant medication check list, PHQ-4, IBS-QOL and WPAI outcomes surveys according to 
the schedule in Table 1. 
 
The EASITx study seeks to enroll subjects from no fewer than 10 medical clinics across several 
U.S. states to capture a geographically diverse IBS population. Subjects will be recruited from 
existing practices and via online recruitment. 

 
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5.2 Scientific Rationale for Study Design 
5.2.1 Rationale for Treatment Frequency 
The 7 digital GDH treatments that compose the North Carolina GDH protocol are administered 
every other week. The frequency of treatment administration in this study was chosen to mirror 
the protocol used in studies of the North Carolina protocol when administered by therapists in 
face-to-face treatment sessions (9, 27). The practice sessions are designed to be administered as 
needed to support engagement, however, there is no evidence that practice sessions modulate 
treatment outcome. The treatment frequency of the comparator control will exactly mirror the 
frequency of GDH treatments and practice sessions.  
 
5.2.2 Rationale for Comparator Control  
The Jacobsonian Muscle Relaxation (JMR) (9) protocol leverages a fully digital platform, which 
allows delivery in a video or audio format. This configuration allows for the blinding of subjects 
to the randomized treatment since muscle relaxation is a credible behavioral treatment. Currently 
in the US, there are no approved digital behavioral therapeutics for the treatment of IBS.  
 
5.2.3 Rationale for Endpoints 
The primary and key secondary endpoints were derived from the FDA guidance on the 
development of pharmaceuticals for the treatment of IBS (28). The WPAI and IBS-QOL are 
validated measures for IBS. The PHQ-4 is a validated four-item questionnaire for anxiety and 
depression (24).  
 
5.3 Premature Termination or Suspension of Study 
5.3.1 Criteria for Premature Termination or Suspension of the Study 
The study will be completed as planned unless either of the following criteria are satisfied that 
require temporary suspension or early termination of the study. 
a) Evidence of a serious clinical problem that would put subjects exposed to treatment 
(either GDH or MR) at risk 
b) Significant violation of Good Clinical Practice (GCP) that compromises the ability to 
achieve the primary study objectives 
 
 
 
6 STUDY POPULATION 
6.1 Screening Events 
Study eligibility is determined at 3 distinct events for the study. These events are: 
 

 
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1. Online pre-screening assessment includes a brief inclusion and exclusion criteria and 
technology assessment (subjects are eligible if they use an iOS or Android smartphone or 
iOS (iPad) tablet released in 2015 or later). 
2. Baseline Screening/Study Physician Visit. The subject’s IBS diagnosis and general 
medical history is confirmed, and complete inclusion/exclusion criteria are applied to 
assess preliminary eligibility. 
3. Day 0 Screening. After the 4 week symptom tracking (Phase 1) the subject’s full 
eligibility for the study is confirmed using data from symptom tracking completed over 
those 4 weeks. Subjects that fail to screen-in will be notified that they are ineligible. 
Subjects that screen-in will be scheduled for a Day 0 phone call and informed of their 
eligibility. 
 
The relationship between the 3 screening events and Phase 1 symptom tracking is shown in 
Figure 2. 
 
Figure 2 
Study Screening 
 
 
Abbreviations: IBS=irritable bowel syndrome. 
 
Only subjects who meet the screening criteria for both screening events will be permitted to 
initiate treatment in the study. 
 
6.2 Inclusion Criteria 
To be eligible to participate in this study, an individual must meet all of the following criteria, 
which are assessed at the Baseline Screening event (see previous section): 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and availability for the duration of 
the study 
3. Male or female, aged 18-70 
4. Confirmation of the IBS and IBS subtype diagnosis by a study physician using Rome IV 
diagnostic criteria (see Appendix A) 
5. Possess an iOS or Android smartphone or an iOS tablet (iPad) released in 2015 or later. 
6. Agreement to input information about their abdominal pain and bowel movements on a 
daily basis into Curebase software 
7. Agreement to have their anonymized data stored in the cloud for up to 2 years after the 
conclusion of the study, and to have the data used for research purposes. 
 
On-line preliminary 
Eligibility 
Device Eligibility 
Schedule Baseline 
Screening 
Study Physician 
Baseline Screening 
Confirm IBS diagnosis by 
Rome IV criteria 
Assess inclusion and 
exclusion criteria  
Phase 1: Symptom 
Tracking 
Subjects contribute daily 
IBS symptom data for 4 
weeks via Curebase. 
Day 0 Screening 
Symptom data from 
Phase-1 is checked for  
1) symptom severity  
2) subject’s ability to 
reliably input data  

 
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8. Agreement to maintain stable dosage of IBS medications during the course of treatment 
and not to add new IBS medication or stop current IBS medications unless directed to do 
so by the subjects treating physician. Changes in treatment will be captured using a 
concomitant medication assessment. 
 
At the Day 0 Screening event, subjects must also meet the following criteria: 
1. Average “Worst Daily Pain Severity” of >3 on an 11-point NRS over the full 28-day 
symptom tracking period 
2. Consistent submission of Pain Severity scores via the Curebase app (data submitted on 
70% or more of days in the symptom tracking window) 
 
This study attempts to achieve excellent representation of women and minorities in the enrolled 
population, and there are no restrictions on eligibility based on the subject’s sex, gender, or race. 
Please see Section 5.5 for information about how women and minorities will be recruited into the 
study.  
 
6.3 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Evidence of current structural intestinal abnormalities that better explain the subject’s 
IBS symptoms (e.g., celiac disease, inflammatory bowel disease – Crohn’s Disease and 
ulcerative colitis, prior abdominal surgeries such as weight loss surgery or bowel 
resection).  
2. Medication use, other illnesses or conditions that can explain their gastrointestinal 
symptoms e.g., regular narcotic use or dependency, OTC stimulant laxative dependence 
(e.g., progressively larger doses of senna or bisacodyl containing compounds are needed 
to produce a bowel movement), radiation to the abdomen. 
3. Diagnosed and/or treated for a malignancy within the past 5 years (other than localized 
basal or squamous cell carcinomas of the skin). 
4. Current psychotherapy, hypnotherapy, or cognitive behavioral therapy (CBT) for IBS 
5. Inability to commit to completing all treatment sessions. 
6. Have an unstable extraintestinal condition whose immediate or foreseeable treatment 
needs would realistically interfere with study demands, e.g., ability to participate in 
online treatment sessions or follow daily diary. 
7. Active: post-traumatic stress disorder, depression associated with high risk of suicidal 
behavior, psychotic or delusional disorders, dissociative disorders, or gross cognitive 
impairment. This exclusion does not apply to anxiety or bipolar disorder. 
8. Subjects that report a current gastrointestinal infection or an infection within the 4 weeks 
prior to the evaluation that would otherwise obscure IBS symptoms. In cases of 
gastrointestinal infection baseline evaluation will be delayed a minimum of 4 weeks until 
after complete recovery.  

 
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9. Current or recent use of a gut-targeted antibiotic such as Neomycin or Rifaximin during 
the 12 weeks prior to baseline assessment. In the case of treatment with rifaximin or 
neomycin, eligibility will be suspended for 12 weeks from the initial date of use. 
10. Any condition that an investigator feels may interfere with the conduct of the study 
 
These exclusion criteria do not present meaningful exclusion of minority populations and do not 
present a threat to population diversity with respect to race, gender, or age. 
 
6.4 Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical study but are not 
subsequently randomly assigned to the study intervention or entered in the study. A minimal set 
of screen failure information is required to ensure transparent reporting of screen failure subjects, 
to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements 
and to respond to queries from regulatory authorities. The primary reason for screen failure, 
demographics and other minimal information is recorded in the eCRF using the following 
categories: 
● AE 
● Did not meet inclusion criteria or did meet exclusion criteria (specify reason) 
● Significant protocol deviation 
● Lost to follow-up during baseline screening 
● Voluntary withdrawal (specify reason) 
● Study termination 
 
Subject ID numbers assigned to subjects who fail screening will not be reused for a different 
subject. Individuals who do not meet the criteria for participation in this study (screen failure) 
because of a conflicting psychological treatment for IBS, either for IBS or another condition 
referenced in the exclusion criteria (e.g. gastrointestinal infection) may be rescreened after the 
period of time indicated in the exclusion criteria (See Section 5.3). Rescreened subjects should 
be assigned the same subject number as for the initial screening. 
 
6.5 Strategies for Recruitment and Retention 
The study seeks to enroll adult subjects, ages 18 to 70 years of age, who have a confirmed 
diagnosis of IBS via the Rome IV diagnostic criteria. To meet the enrollment goal of 
approximately 380 randomized subjects and 300 evaluable subjects (estimated maximum 20% 
study dropout rate) patients will be recruited from participating clinic populations (study 
physicians will be authorized to screen their own subject population for eligibility) and subjects 
who have been recruited and prescreened via online, digital channels.  
 

 
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Planned traditional recruitment channels include: 
● Distribution of flyers to our clinics 
● Distribution of flyers to university health centers 
● Informational outbound phone calls to subjects from study staff 
● Referrals by family members of subjects to the study 
 
Planned digital recruitment channels include: 
● Social media community groups 
● Facebook 
● Craigslist 
● Instagram 
 
It is desirable to enroll many minorities and women and create a diverse population. 60-65% of 
IBS subjects are female. No special action will be employed to ensure adequate female 
enrollment.  
 
Subjects will be compensated for participation in the study.  
 
Participants will receive their compensation payments via Curebase so long as they continue to 
contribute data consistently. Payments will be withheld for subjects that fail to complete >5 out 
of 7 of the weekly abdominal pain score surveys. Participants will be provided a warning after 
they miss 1 of the weekly data collection points. 
 
 
 
 
 
7 STUDY INTERVENTION 
7.1 Study Intervention Administration 
 
7.1.1 Study Intervention Description 
The metaMe Health digital GDH product for IBS is named Regulora. Regulora is an IBS-
specific treatment platform delivered via a smartphone, tablet, or personal computer. The 
delivery platform for EASITx is a mobile app available in the Apple and Android app stores 
under the name of EAGLEFISH. The GDH treatment module was adapted from a standardized 
scripted therapist-administered GDH protocol referred to as the North Carolina Protocol (10,27). 
The North Carolina protocol has been licensed by metaMe Health from the inventor (Dr. Olafur 
Palsson) for exclusive use through any electronic means. 
 

 
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The North Carolina protocol differs from standard hypnotherapy through the use of intensive 
relaxation methodology, IBS-specific use of metaphor, symptom imagery, and direct and indirect 
suggestion (27). The North Carolina protocol consists of 7 unique treatment sessions each lasting 
~30 minutes provided every-other week over 12 weeks. The first half of the 30-minute treatment 
session is spent producing deep physical and autonomic relaxation, along with a mental state of 
narrowed focus of attention and heightened receptivity to suggestions, commonly referred to as 
the trance state. This is followed by the use of metaphorical storytelling, and a combination of 
direct and indirect suggestions targeted at somatic control and perception mechanisms that 
influence IBS symptoms. The treatment sessions are iterative and progressively build relaxation 
skills, which are required to maximally incorporate the disease-specific aspects of treatment. 
Subjects become familiar with the use of hypnotherapy tools such as counting and the use of 
imagery focused on the senses, i.e., touch, smell, sight and hearing (see Appendix B for scripts of 
the 7 sessions). As treatment sessions progress, direct suggestion and metaphor are used to 
overcome the exaggerated response to pain signals imparted by the anticipatory response to IBS 
symptoms.  
 
The comparator control group will listen to digital video/audio recordings of 7 guided muscle 
relaxation (MR) sessions of approximately equivalent length to the GDH sessions (see Appendix 
D for session scripts), as well as a daily practice session approximately equivalent in length to 
the GDH practice sessions (see Appendix E for script) (9). Guided MR was chosen as the 
comparator control treatment after consultation with the FDA because of (a) the ease with which 
it can be adapted to a digital format and support the creation of a comparator treatment and (b) 
credibility as a treatment for IBS albeit with limited demonstrated efficacy (9). 
 
The GDH and MR treatment modules consist of seven ~30-minute digital video and audio 
recordings of a female therapist. The video component of the treatment sessions occurs at the 
beginning of the treatment session and is used to simulate the face-to-face interaction of the 
therapist encounter. The video component is short and typically lasts less than 5 minutes before 
the screen goes black and subjects are taken through the audio component of treatment. The 
digital production of the GDH and MR scripts was a verbatim reading. In the case of the GDH 
scripts the therapist reader provided hypnotherapy-appropriate speech patterns (inflection, pause, 
and tone). Once therapy is initiated, subjects receive all 7 treatment sessions, every other week 
for a total treatment period of 12 weeks. During the 13 days between treatment sessions, a short 
audio session referred to as a “practice session” is made available to subjects. There is a single 
practice session script for each of the two treatment arms lasting 15 minutes. Subjects receive 
text message and email reminders with a recommendation to complete a minimum of three 
practice sessions during the 13 days between treatments. Practice sessions are recommended but 
not required (see Appendix C and Appendix E: Daily Practice Sessions). 
 

 
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The metaMe treatment platform also tracks subject use and progress with treatment modules. For 
example, the exact time that a subject starts and stops a treatment or practice module is captured 
by the treatment platform. The software also tracks treatment sessions and only allows subjects 
to access treatments in sequence. The metaMe treatment platform on the EAGLEFISH app 
contains these major functional elements: 
1. Treatment videos/audios 
2. A secure cloud-based data repository.  
3. A simple user interface (UI) with an arrow play button that starts the treatment session. 
(see Figure 3)  
 
In addition to the EAGLEFISH app, subjects enrolled in the EASITx study will be required to 
enter study data in a second platform. The Curebase platform is for data collection and 
administers the daily ePRO and provides access to periodic surveys. Subjects will be introduced 
to the Curebase platform at the baseline screening clinic visit by the research study staff. Study 
staff will explain the use of the app and the process by which subjects will enter data in the 
ePRO. 
 
After completion of the 4-week run-in period (Phase 1), subjects will be informed of eligibility, 
and eligible subjects will be scheduled for a day 0 phone call (scheduled as soon as possible but 
no more than 14 days from completion of the run-in period). On the day 0 phone call, after a 
subject is randomized, the Curebase staff will confirm the subject’s preferred day of the week, 
time of day and start date for treatment. Curebase staff will enter the treatment schedule and 
randomization code (blinded treatment allocation) into a secure metaMe portal that automatically 
triggers the assigned treatment and the subject-specific treatment reminder and scheduling 
system. Curebase staff will assist subjects in accessing the metaMe digital platform by guiding 
them through the process of creating a metaMe login username and password and reviewing the 
process for accessing the treatment app. Subjects will be guided through the login process and 
directed to the navigation menu. The navigation menu contains the following items:  
1. The home button  
2. Account information 
3. Treatment schedule 
4. Logout 
5. Help section. Contains a link to watch or read a transcript to the intro video (see below), 
FAQ and contact information for technical support and problems with treatment. 
 
The treatment process will commence within 7 days of the day 0 call and will be initiated by 
system-generated text and email reminders of upcoming treatment sessions. Subjects will be sent 
an email reminder 24 hours and 1 hour before each session, and a text message reminder 5 
minutes before each session. Subjects will be able to access the treatment app via a hyperlink in 
these messages or directly by opening the app on their device. Once in the app, subjects will 

 
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initiate treatment by pressing the large arrow start button on the home screen (see User Guide 
and Figure 3). The first thing subjects will see is a short 3-minute intro video that explains the 
following details of treatment:  
 
1. Treatment session length 
2. The treatment reminder system, which uses emails and text messages to alert subjects of 
upcoming treatment sessions and to remind subjects to complete treatment. 
3. The process for rescheduling and managing missed treatment sessions (subjects have 3 
additional days to complete the treatment before they are considered a missed treatment) 
4. Rules on interrupted treatment sessions (subjects must start over from the beginning and 
have 3 opportunities to finish the treatment before they are considered a missed 
treatment)  
5. The recommended minimum number of practice sessions is 3 over the 13 days between 
treatments.  
 
There are two intro videos customized to each of the two treatments. They differ in the 
treatment-specific instructions; in the case of the GDH treatment, the video has specific 
instructions on how to manage re-alerting after hypnotherapy (see Appendix F). In the case of 
the MR treatment, subjects are given guidance on how to manage muscle-specific complaints 
(see Appendix G) After the completion of the treatment session, subjects will be instructed to 
click a button indicating they have completed the session. This button appears upon completion 
of 100% of the length of the treatment session. A session is also considered completed if greater 
than 95% of the video is played and no button is pressed by midnight of that day local time. 
Subjects who miss their scheduled treatment will have 3 additional days in which to complete the 
treatment. They will receive daily text and email reminders to complete treatment. If after 3 days 
the subject has not completed the treatment session they will be locked out of that treatment and 
it will be scored as a missed treatment session. Similarly, subjects will receive a one-time 
reminder about Practice sessions on the 5th, 8th, and 11th day after each treatment. Subjects will 
be allowed to access one practice session per day for as many non-treatment days as they like but 
they will only receive 3 reminders at the indicated days.  
 
The subject experience with the EAGLEFISH app is illustrated in the User Guide and briefly in 
Figure 3. 
 

 
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Figure 3 
metaMe Treatment Visual Narrative 
 
EAGLEFISH User Interface (UI) 
When subjects open the EAGLEFISH app, the main screen 
appears. The large arrow button, when clicked, is used to access 
treatment and practice sessions. The first time the button is 
pressed, the patient will view the introduction video, which is 
required viewing before the first treatment session and optional 
thereafter. The app is programmed so that the appropriate content 
(a treatment or practice session) is displayed each day. Subjects 
are prevented from re-taking treatment sessions, and subjects 
cannot access practice sessions on days they have a treatment 
available (the assigned treatment day plus 3 days in the case that 
subjects miss treatment on their assigned treatment day). Subjects 
will be required to complete the treatment/practice session in a 
single sitting. If the subject is interrupted during treatment, the 
subject may press the “begin again” button, which starts the 
session over from the beginning. In this case, subjects will be 
required to re-start the treatment/practice session from the 
beginning. Subjects will have 3 days after the initial treatment day 
to complete treatment sessions. After the treatment/practice 
session video has played to 100% of its length, subjects may 
indicate that they have completed the session by clicking on the 
“Complete Session” button. A session is also considered 
completed if greater than 95% of the video is played and no button 
is pressed by midnight of that day local time. 
 
7.2 Measures to Minimize Bias: Blinding and Randomization 
7.2.1 Blinding 
Blinding of participants to treatment in a psychological or behavioral intervention is generally 
not possible. By the nature of the intervention, subjects are aware of the type of intervention they 
are receiving. Instead, in studies involving a psychological or behavioral intervention, blinding 
the participants to the hypothesis being evaluated in the study is considered the best and most 
practical strategy for preventing study bias. The EASITx study incorporates this blinding 
strategy coupled with state-of-the-art IBS and behavioral research methodology.  
 
The comparator-treatment platform will be identical to the GDH treatment platform, except that 
muscle relaxation (MR) audio recordings equal in treatment duration and frequency of 

 
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administration will be substituted for the GDH video/audio recordings. The comparator control 
group will listen to digital audio recordings of 7 guided muscle relaxation (MR) sessions of 
approximately equivalent length to the GDH sessions (see Appendix D for session scripts), as 
well as a daily practice session approximately equivalent in length to the GDH practice sessions 
(see Appendix E for script) (9). Guided MR was chosen as the comparator control treatment after 
consultation with the FDA because of (a) the ease with which it can be adapted to a digital 
format and support the creation of a comparator treatment and (b) credibility as a treatment for 
IBS albeit with limited demonstrated efficacy (9). The goal of this blinding strategy is to present 
two treatments that are credible to the study participants, who are themselves unaware of what 
the other study arm is, whether their assigned treatment (GDH or MR) is the one under study 
being compared to the other arm, or indeed whether both are active treatments being compared to 
each other.  
 
The data collection (ePRO) system creates a double blind and eliminates the potential for 
investigator bias. metaMe staff and investigators will not have knowledge of group assignments, 
with the following exceptions:  
● An independent statistician who will formulate the randomization tables. 
● A firewalled Curebase staff member who will enter the treatment group assignment on 
the metaMe platform.  
● A firewalled metaMe staff member (the CTO) who will monitor technical aspects of the 
study to ensure technical compliance to the protocol and in this capacity may have access 
to participant randomization assignments.  
 
 
7.2.2 Randomization Code Creation and Procedure 
Following successful completion of the run-in period, subjects will be randomized 1:1 to either 
GDH or comparator MR treatment. Randomization will be stratified by gender and IBS subtype. 
Eight separate randomization schedules will be generated to account for the stratification 
(Male/IBS IBS-C, Male/IBS-D, Male/IBS-M, Male/IBS-U, Female/IBS-C, Female/IBS-D, 
Female/IBS-M, Female/IBS-U). Additionally, continuous monitoring of enrollment will occur to 
ensure that at least approximately 20% of the randomized population is male and at least 
approximately 25% of the randomized population includes each of the three major IBS subtypes 
(IBS-C, IBS-D, and IBS-M). Screening of female subjects will be discontinued if approximately 
270 female subjects are randomized. If randomization into a particular IBS subtype reaches 
approximately 144 subjects, then screening of subjects with that particular IBS subtype will be 
temporarily discontinued until the IBS subtypes lacking enrollment have randomized 
approximately 90 subjects. Finally, if randomization into the rare IBS-U subtype reaches 20 total 
subjects, enrollment will be discontinued for that subtype. 

 
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The randomization schedule will be prepared by an unblinded statistician before the start of the 
study. As this is a double-blind study, only unblinded personnel (unblinded statistician, Curebase 
randomization staff) will have access to the randomization schedule before official unblinding of 
treatment assignment post database lock.  
 
Randomization will occur during the “Onboarding Call” when a member of the Curebase 
randomization staff will enter the treatment group allocation on the metaMe platform. No subject 
will be randomized into this study more than once. All randomization information will be stored 
in a secured area, accessible only by authorized personnel. 
 
7.2.3 Unblinding and Decoding Procedure 
The study treatment blind shall not be broken unless information concerning the study treatment 
is necessary for the medical treatment of the subject. In the event of a medical emergency, if 
possible, the medical monitor should be contacted before the study treatment blind is broken to 
discuss the need for unblinding.  
 
The sponsor must be notified as soon as possible if the study treatment blind is broken and 
record the date and time. The study treatment can be unblinded by the designated unblinded 
Curebase staff member. The reason, time and date the blind is broken must be recorded in the 
eCRF. 
 
7.3 Participant compliance to Study Intervention  
Curebase will store all study subject-reported data generated through the Curebase web 
application on a secure and HIPAA-compliant database. However, subject adherence data, 
defined as completion of required treatment sessions and numbers of practice sessions will be 
generated by our video server, Wistia. Wistia is a video hosting service that is able to securely 
keep and record detailed information about when and how long videos are accessed by a given 
user. Wistia-generated usage data is anonymously generated and stored and is transferred to 
metaMe through an API and matched to a subject ID (email address) on metaMe servers. 
Linking usage data to email address is a necessary part of the metaMe notification and treatment 
tracking system. Usage data is used to generate adherence information that is in turn used to send 
reminders and prompts for a missed treatment session. Note that most other subject notifications 
like appointment reminders are generated based on the treatment schedule, not real-time 
adherence data. The adherence data is also used to ensure that the proper treatment content is 
available at the correct time and in the correct sequence. For example, the app may use the data 
from Wistia to determine if a session has been completed on the scheduled day; if it is not, the 
session remains available to the subject throughout the treatment window. If the session is 
completed, a practice session is made available the following day. Each day, all adherence data is 
transferred to the Curebase platform and stored. Curebase will provide long-term, HIPAA 

 
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compliant storage of adherence data for use in later analysis. Intervention compliance will be 
calculated by determining the number of completed treatment sessions and the number of 
completed practice sessions for each subject. We also will collect related contextual data, such as 
how much of the video was watched per attempt, whether the session was restarted at any point, 
whether the session was rescheduled, and whether the session was viewed late (after the 
scheduled day).  
 
7.4 Concomitant Therapy 
Requirements and proscriptions on concomitant therapy are outlined in the Inclusion/Exclusion 
Criteria (Section 5.2 and Section 5.3). 
 
Concomitant medication is any drug given in addition to the study treatment. These may be 
prescribed by a physician or obtained by the subject over the counter and are not provided by the 
sponsor. Subjects will be allowed to continue use of any concomitant IBS medications including 
probiotic supplements as permitted by the study inclusion and exclusion criteria. Subjects are 
required to maintain a stable dose during the treatment period unless otherwise advised by a 
physician. Changes to concomitant medications shall be evaluated at the predetermined 
timepoints. Dosage and frequency of treatment will be collected at the beginning of the study and 
again at week 8, 16, 38 and 64. Concomitant medication therapy will be coded using the WHO-
DDE Medical Coding Dictionary.  

 
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8 STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
8.1 Criteria for Discontinuation or Withdrawal of a Subject 
GDH is a non-significant risk behavioral intervention. Given this, there are no foreseeable 
safety-related reasons to discontinue the study. Subjects may freely withdraw their individual 
participation in the study at any time. However, in case there is a reason for discontinuation or 
withdrawal of the subject from the study this should be recorded in the eCRF using the following 
categories (for screen failure subjects, refer to Section 5.4): 
1. Treatment discontinuation due to an AE. The subject has experienced an AE that in 
the opinion of the investigator may expose them to undue risk or could interfere with 
his/her continued participation in the study. 
2. Important protocol deviation. The discovery post randomization that the subject failed 
to meet protocol entry criteria or did not adhere to protocol requirements, and 
continued participation poses an unacceptable risk to the subject’s health, following 
consultation with the sponsor or designee.  
3. Lost to follow-up. The subject stops responding to requests and reminders for data 
collection or treatment and attempts to contact the subject were unsuccessful. 
Attempts to contact the subject must be documented in the subject’s electronic source 
documents.  
4. Voluntary withdrawal. The subject (or subject’s legally acceptable representative) 
wishes to withdraw from the study. The reason for withdrawal, if provided, must be 
recorded in the eCRF. Note: All attempts should be made to determine the underlying 
reason for the withdrawal and where possible, the primary underlying reason should 
be recorded (i.e., withdrawal due to an AE should not be recorded in the “voluntary 
withdrawal” category. Similarly, lack of efficacy should not be recorded in the 
“voluntary withdrawal” category). 
5. Study termination. The sponsor, IRB, or regulatory agency terminates the study. 
6. Subject is found to have a life-threatening medical illness or serious mental health 
disorder 
7. Any other clinical event or finding that, in the opinion of the study team, jeopardizes 
subject safety, privacy, or the scientific validity of the study. 
 
8.2 Procedures for Discontinuation or Withdrawal of a Subject 
The investigator may discontinue a subject’s study participation at any time during the study 
when the subject meets the study termination criteria described in Section 8.1. In addition, a 
subject may discontinue his or her participation without giving a reason at any time during the 
study. Should a subject’s participation be discontinued, the primary criterion for termination 
must be recorded by the investigator. Subjects withdrawn by the sponsor due to investigator error 
in applying protocol inclusion/exclusion criteria or technical issues in the Curebase software that 

 
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prevent appropriate execution of the trial will be replaced.  Otherwise, subjects will not be 
replaced. 
 
8.3 Lost to Follow-Up 
When a subject misses a required treatment session, there is a 3-day grace period during which 
subjects can access treatment from the app. During this time, subject will receive email and text 
message reminders to complete treatment. Similarly, subjects that miss a data collection point 
will be contacted by Curebase via email and phone and in the case of surveys, Curebase will 
attempt to contact the subject and reschedule the missed data collection as soon as possible. The 
study physician staff and Curebase will counsel the subject on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the subject wishes to and/or should continue 
in the study. Subjects that do not respond to contact attempts and do not complete the minimum 
number of surveys in phase 3 will be classified as described in the Statistical Analysis Plan.

 
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Study Assessments and Procedures 
8.4 Efficacy Assessments 
The efficacy of GDH will be established using a set of patient-reported outcomes (PROs). These 
include PROs to capture: 
● Abdominal Pain 
● Stool Consistency 
 
The primary endpoint of EASITx is abdominal pain, and as such the most important PRO 
instrument in the study is the Abdominal Pain Daily Survey. 
 
Stool frequency and consistency are secondary endpoints of EASITx, so the second-most 
important PRO instrument in the study is the Daily Stool Consistency Diary, which uses the 
Bristol Stool Scale Form. 
 
Other PROs are assessed at baseline (Week -4), the final week of Phase 3 (week 16), and via the 
LTE questionnaires at 6-months post-treatment (week 38) and 12-months post-treatment (week 
64). These include: 
● IBS Quality of Life 
● TIS (measured at baseline only) 
● WPAI (also at week 8) 
● PHQ-4 
● Adequate Relief 
 
The Satisfaction Questions will be asked only during the last week of Phase 3 (week 16). 
 
Certain endpoints will be calculated based on the data input via the PROs. These include: 
● Stool frequency 
● Pain frequency 
 
During the baseline visit, physicians will obtain questions regarding the subject’s medical 
history; for example, physicians will inquire about prior treatments for IBS and history of taking 
medications that may conflict with the eligibility criteria for the study. However, no medical 
records or EMR-originating source documentation will be collected. The IBS diagnosis is 
established at the baseline visit via Rome IV criteria. There is no imaging or laboratory testing 
required in the study and all endpoints are obtained via PROs via the Curebase software. 
All subjects who enroll in EASITx will electronically sign a HIPAA Authorization Form, which 
permits the use of a pseudonymized form of their data to be used for research purposes.  
 

 
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8.4.1 Daily Abdominal Pain Intensity  
The daily pain intensity measurement is recorded at approximately the same time each day and is 
the worst abdominal pain score for the previous 24-hour period using the 11-point NRS of pain 
intensity.  
 
8.4.2 Daily Abdominal Pain Frequency 
The daily pain frequency measurement is derived from the daily pain intensity measurement. 
Days where severity is >0 are considered a day with pain and are recorded as positive. Days with 
a score of 0 are days without pain.  
 
8.4.3 Daily Stool Consistency 
The daily stool consistency measurement is based on the Bristol Stool Form Scale (BSFS). The 
BSFS is a scale with pictures and associated descriptions of stools with different consistency. 
The stool consistency is designated on the scale as 1 (separate hard lumps) to 7 (watery, no solid 
pieces) and is recorded at approximately the same time each day by referring to pictures and 
verbal descriptors in the Curebase ePRO (29).  
 
Subjects will be asked for the number of bowel movements in the previous 24 hours. For days 
where subjects report >1 bowel movement they will use the BSFS to score the worst stool in the 
preceding 24 h period.  
 
8.4.4 Daily Stool Frequency 
All subjects will record the daily number of bowel movements for the previous 24-hour period.  
 
8.4.5 IBS-QOL 
The IBS-QOL is a 34-item questionnaire (21). The items are summed and transformed to a 0-
100-point scale. Higher scores indicate better IBS quality of life. The mean IBS-QOL score 
measured at weeks 16, 38, and 64 will be used for comparison. 
 
8.4.6 WPAI 
The WPAI is a 6-question survey of presenteeism and absenteeism (22). Because it has a recall 
period of 7 days, it will be measured at the baseline screening visit, week 8, week 16, and again 
during the LTE at weeks 38 and 64.  
 
8.4.7 TIS 
The TIS is a 17-item questionnaire of personal characteristics thought to be related to therapeutic 
response to clinical hypnosis (23). TIS will be measured at baseline in the pre-treatment run-in 
period and used to model outcomes at treatment completion. 
 

 
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8.4.8 PHQ-4 
The PHQ-4 is a simple 4 item measure of anxiety (2 items) and depression (2 items) (24). Each 
item is scored on a 4-point (0-3) NRS and the items are summed to give a total score ranging 
from 0-12. The total score provides an assessment of psychological distress. The 2-item anxiety 
and depression scales can also be scored and scores of 3 or greater are considered positive for 
screening purposes. The PHQ-4 will be measured at baseline in the Phase 1 pre-treatment run-in 
period, week 16 (Phase 3), week 38, and at week 64 in the LTE.  
 
8.4.9  Adequate Relief Question 
The following question will be asked during week 16, 38, and 64 via the Curebase data 
collection (ePRO) system:  
● On average, over the past 2 weeks have you had adequate relief of your IBS symptoms? 
(Y/N) 
 
8.4.10  Satisfaction Questions 
The following questions will be asked during the last week of Phase 3 (week 16) via the 
Curebase data collection (ePRO) system:  
● Overall, how satisfied were you with the therapy you received? (1-5 scale) 
● Would you recommend the therapy you received to someone with IBS? (Y/N) 
● Would you recommend using the therapy you received before trying a prescription drug? 
(Y/N) 
 
8.5 Safety and Other Assessments 
Safety will be assessed using AE reporting (see Section 9.3). 
 
8.5.1 Concomitant Medication/Therapy 
Concomitant medications and treatment will be collected at the baseline screening visit, week 8 
and week 16. Concomitant medications and treatment use will also be collected at week at 38 
and 64 in the LTE. The following information will be collected: 
1. Concomitant Medications  
a. Medication name 
b. Indication 
c. Medication form (e.g., tablet, capsule, etc.) 
d. Medication dose units (e.g., gram, IU, etc.) 
e. Medication schedule (e.g., QD, BID, etc.) 
f. Start date 
g. End date 
2. Non-medication Therapy 

 
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a. Indication 
b. Schedule/Frequency (daily, weekly, monthly, other) 
c. Type of therapy 
i. Physical therapy 
ii. Occupational therapy 
iii. Psychotherapy (talk therapy) 
iv. Cognitive Behavioral therapy (CBT) 
v. Counselling 
vi. Guided self-help 
vii. Behavioral activation 
viii. Mindfulness therapy 
ix. Other 
d. Start date 
e. End date 
 
8.5.2 Blinding Assessment 
Subject blinding will be assessed in the last week of Phase 3 using the following question:  
Even if you do not feel you received benefit from your treatment program, do you believe 
the program you received could be beneficial to others with IBS?  
 
Answers will be on a 7-point NRS, with the following guidelines: 
1 – Definitely could not help others with IBS 
4 – May or may not help others with IBS 
7 – Definitely could help others with IBS 
 
Given that this study is hypothesis blinded, the blinding assessment is designed to assess the credibility 
of the treatment and the credibility of the comparator as a treatment for IBS. 
 
8.6 Adverse Events and Serious Adverse Events 
8.6.1 Definition of Adverse Events 
Adverse event1 means any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs in subjects, whether or not related to the investigational medical device 
(21 CFR 312.32 (a)). 
 
In the context of the investigational device, an AE constitutes: 
● any unintentional, unfavorable clinical sign or symptom, including complications of IBS 
(but not IBS itself). 
● any new illness or disease or the deterioration of existing IBS 
 
1 ISO14155 and 21 CFR 812 

 
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● any clinically significant deterioration in any clinical assessment or outcome measure 
● Any adverse event resulting from insufficiencies or inadequacies in the instructions for 
use, the deployment, the installation, the operation or any malfunction of the 
investigational medical device. This includes any event that is a result of a use error or 
intentional abnormal use of the investigational medical device 
 
Pre-existing conditions (unless worsened significantly during treatment) or routine diagnostic 
and therapeutic procedures normally administered in the treatment of IBS do not constitute AEs. 
AEs will be collected from the time a subject signs the informed consent until study withdrawal, 
screen failure, or study completion.  
 
If the subject experiences a worsening or complication of an AE after ongoing treatment, the 
worsening or complication should be recorded as a new AE. Investigators should ensure that the 
AE term recorded captures the change in the condition (e.g., “worsening of…”). 
 
In this study, it is possible that some subjects may experience a worsening of IBS symptoms. As 
the primary endpoint of this study, worsening of IBS symptoms is captured as part of the 
efficacy parameter. Worsening of IBS symptoms should not be considered an AE unless the 
worsening of the symptoms is associated with a cause other than the subject’s IBS. 
 
All AEs that occur in study subjects during the AE reporting period specified in the protocol 
must be reported, WHETHER OR NOT THE EVENT IS CONSIDERED RELATED TO THE 
STUDY TREATMENT. 
 
NONSERIOUS AEs are to be documented on the AE CRFs. 
 
8.6.2 Definition of Serious Adverse Events 
An AE that meets one or more of the following criteria/outcomes is classified as serious (term 
definitions follow):  
● Death 
● Is deemed life-threatening 
● Results in inpatient hospitalization or prolongation of an existing hospitalization 
● Results in persistent or significant disability/incapacity or substantial disruption of the 
ability to conduct normal life functions,  
● Results in a congenital anomaly/birth defect 
● Important medical event  
 
Term definitions: 
Life-threatening – Any AE that places the subject at immediate risk of death from the 
event as it occurred. A life-threatening event does not include an event that might have 

 
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caused death had it occurred in a more severe form but that did not create an immediate 
risk of death as it actually occurred.  
 
Hospitalization – Hospitalization is defined as an overnight admission with observation 
of a minimum of 24 hours. A hospitalization planned before the start of the study for a 
preexisting condition that has not worsened does not constitute an SAE (e.g. elective 
hospitalization for a total knee replacement due to a preexisting condition of osteoarthritis 
of the knee that has not worsened during the course of the study).  
 
Disability – Defined as a substantial disruption in a person’s ability to conduct normal 
life functions.  
 
Congenital Anomaly/birth defect: Congenital anomaly/birth defect in offspring, or led 
to fetal distress, or fetal death 
 
Important Medical Event – is an event that may not result in death, be life-threatening, 
or require hospitalization but may be considered serious when, based upon appropriate 
medical judgment of the study physicians, the event may jeopardize the subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include suicidality, psychosis, behavioral 
upset, or emergent medical condition requiring emergency hospitalization or intervention. 
 
8.6.3 Classification of an Adverse Event 
 
8.6.3.1 Severity of Event 
For AEs not included in the protocol defined grading system, the following guidelines will be 
used to describe severity: 
 
● Mild – Events require minimal or no treatment and do not interfere with the subject’s 
daily activities or safety. 
● Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning or safety. 
● Severe – Events interrupt a subject’s usual daily activity and may require active medical 
treatment or intervention to ameliorate. Severe events are usually potentially life-
threatening or incapacitating. Of note, the term “severe” does not necessarily equate to 
“serious”. 
 
8.6.3.2 Device related AEs 
Device-related adverse events are events directly attributable to the device itself. 
● Adverse Device Effect (ADE): Non-serious adverse event related to the use of an 
investigational medical device 

 
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● Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in any of 
the consequences characteristic of a serious adverse event. 
 
8.6.3.3 Serious Unanticipated Adverse Device Effect 
Serious Unanticipated Adverse Device Effects (SUADEs) are any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan. 
 
8.6.3.4 Relationship to Study Intervention 
All AEs must have their relationship to study intervention assessed by a clinician who examines 
and evaluates the subject based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below. In a clinical study, 
the study treatment must always be suspect.  
● Reasonable Possibility – A clinical event, including an abnormal clinical test result, 
whose temporal relationship to study treatment makes a causal relationship possible. 
(There is reasonable evidence to suggest a partial or direct causal relationship e.g., the 
event occurred within a reasonable time after administration of the study treatment). 
Other factors may have contributed to the event (e.g., the participant’s clinical condition, 
other concomitant events). 
● No Reasonable Possibility – A clinical event, including an abnormal clinical test result, 
whose temporal relationship to study treatment makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
treatment) and in which other therapies or underlying disease provides more plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
 
8.6.3.5 Anticipated AEs: 
The following are anticipated AEs that one or more scientific publications have previously 
identified as possibly related to GDH or MR therapies: 
● Headache 
● Drowsiness 
● Fatigue 
● GI discomfort 
● Muscle tightness  
● Muscle soreness 
 
The Sponsor will be responsible for determining whether an AE is device-related or not.  
 

 
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8.6.3.6 Device malfunction 
Device malfunction denotes a failure of one or more of the components of digital app that could 
potentially result in lack of patient access to the digital app, inconvenience. The manufacturer 
must confirm device failure.  
 
8.6.4 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study 
visits and interviews of a study subject presenting for medical care, or upon review by a study 
monitor. 
 
All AEs including not meeting the criteria for SAEs will be captured on the appropriate eCRF. 
Information to be collected includes event description, date of onset, clinician’s assessment of 
severity, relationship to study product (assessed only by those with the training and authority to 
make a diagnosis), and date of resolution/stabilization of the event. All AEs occurring while on 
study must be documented appropriately regardless of relationship. All AEs will be followed to 
adequate resolution. 
 
Any medical condition that is present at the time that the subject is screened will be considered 
as baseline and not reported as an AE. However, if the study subject’s condition deteriorates at 
any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
 
The study team will record all events with start dates occurring any time after informed consent 
is obtained through the end of Phase 4 (LTE) or until the end of study participation.  
Events will be followed for outcome information until resolution or stabilization. 
 
8.6.5 Adverse Event and Serious Adverse Event Reporting  
The occurrence of AEs, SAEs, and Protocol Deviations (PDs) shall be reported through a 
unidirectional, HIPAA-compliant, web-based communication channel. Event reports may be 
initiated at any time by the subject or the investigator. All logging of event reports shall be 
retained for the duration of the study to provide proper documentation in accordance with FDA 
and ICH GCP requirements. The adverse event will be triaged based on subject content and 
urgency.  
 
In the event of an AE, SAE, or PD, the message will be immediately sent to the Curebase team 
for determination of severity and relatedness to the investigational treatment. The study team will 

 
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collect information from the subject as necessary and create a final event report for logging 
within a specified timeframe. Reports containing AEs will be processed and documented.  
 
Reports containing SAEs shall be completed and filed per regulatory requirements. The 
information in a SAE report should be completed as fully as possible and contain at a minimum: 
● Subject ID number 
● Start date of the event 
● Description of the event 
● Study physician’s name 
● Investigator causality assessment 
● Investigator seriousness assessment 
 
If safety information not available at the time of the first report becomes available at a later date, 
the study team member should submit follow-up safety information to Curebase. All SAEs 
should be followed up until resolution or permanent outcome of the event. The timelines and 
procedure for follow-up reports are the same as those for the initial report. Detailed study 
reporting procedures shall be standardized as documented in a formal Safety Monitoring Plan.

 
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9 Statistical Considerations 
A Statistical Analysis Plan (SAP) will be prepared and finalized before unblinding of subjects’ 
treatment assignment. This document will provide further details regarding the definition of 
analysis variables and analysis methodology to address all study objectives. A blinded data 
review will be conducted before unblinding of subject’s treatment assignment. This review will 
assess the accuracy and completeness of the study database, subject evaluability, and 
appropriateness of the planned statistical methods. 
 
9.1 Statistical Hypotheses 
The primary endpoint for this study will be the proportion of overall pain intensity responders to 
GDH and comparator following 12 weeks of treatment. An abdominal pain intensity responder is 
defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks of Phase 3 
(weeks 13 through 16) is 30% reduced compared to the daily abdominal pain intensity averaged 
over the 4 weeks of the Phase 1 run-in (weeks -4 through -1).  
 
The proportion of responders in each treatment group in the Intent-to-Treat (ITT) population will 
be estimated along with corresponding two-sided 95% confidence intervals (CIs). For this study 
the null and alternative hypotheses that will be tested are: 
● H0: P1 = P2 
● H1: P1 ≠ P2 
Where P1 and P2 are the proportion of responders in GDH and Comparator treatment groups, 
respectively. 
 
9.2 Sample Size Determination 
In this study, 380 subjects will be randomized in a 1:1 ratio to GDH or comparator to ensure that 
at least 300 subjects complete their Week 13-16 assessment for analysis. Three hundred (300) 
subjects completing Phase 3 will provide at least 90% power to detect an 18 percentage point 
difference in response rates between the GDH and comparator treatment groups at the 5% 
significance level. The study was powered assuming that the comparator treatment group is 
expected to demonstrate a 26% response rate. To determine the expected response rate in the 
comparator treatment group, two studies of GDH reporting data that utilized dichotomous 
outcome measures were examined. The first (9) used an endpoint of % treatment responders 
(defined as a >50% reduction in IBS-SSS). In this study, 52% of subjects in the GDH group and 
26% of subjects in the control group (usual care) were responders. A more recent study by Flik et 
al (12) reported an “adequate relief” response rate of 40% in the GDH group compared to 17% in 
the Edu control group. It is believed the response rate in the comparator treatment group in this 
study is likely to be ~26%. 
 

 
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9.3 Populations for Analyses 
Enrolled Population: The enrolled population will include all subjects who sign informed 
consent and meet the inclusion/exclusion criteria.  This population will be used for 
evaluation of demographics and baseline characteristics. 
Intent-to-Treat (ITT) Population: The ITT population will include all subjects who are 
randomized to treatment. Subjects that are replaced due to failed inclusion/exclusion 
criteria or technical issues in the Curebase software will be excluded. This population will 
be used for the evaluation of efficacy and all safety analyses. 
Per Protocol (PP) Population: The PP population will consist of all subjects in the ITT 
population with no major protocol deviations that may affect efficacy. This population will 
be used as a supportive analysis of the primary endpoint. 
 
9.4 Statistical Analyses 
9.4.1 General Approach 
The SAS System, Version 9.4 (or higher), will be used for all analyses, unless otherwise 
specified. Continuous variables (e.g., age) will be summarized using the number of observations 
(n), mean, standard deviation (SD), median, minimum, and maximum. Categorical variables 
(e.g., sex, race) will be summarized using the number of observations (n) and percentage in each 
category. 
 
All data used in analyses and/or collected during the study will be provided in listings. 
Subjects withdrawn prior to end of Phase 3 (Weeks 13-16) assessment period will be considered 
as prematurely withdrawn. All available data for subjects who prematurely withdraw from the 
study will be included in all analyses. All 4-week assessment periods in MMRM and GEE 
models will include:  Phase 1 (weeks minus 4 through minus 1), Phase 2 weeks 1-4, Phase 2 
weeks 5-8, Phase 2 weeks 9-12, Phase 3 (weeks 13-16), LTE Period 1 (weeks 35 through 38), 
and LTE period 2 (weeks 61 through 64). At timepoints during the study that require 4 weeks of 
daily IBS symptom and pain assessment, at least 50% of the required assessments must be 
collected to be able to derive the average daily abdominal pain intensity and like endpoints. 
Study withdrawals, reasons for withdrawal, and missing assessment collections will be 
summarized. 
 
Analyses of treatment will be performed using two different approaches to account for missing 
data during the treatment phase: 

 
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1. At-assessment Analysis: Missing values at post-baseline assessments will not be replaced 
and will be regarded as missing in analyses.  
2. Multiple Imputation: Missing values at post-baseline assessments will be imputed using 
the multiple imputation method.  
 
Additional details of the statistical methods are provided in the SAP.  
 
9.4.2 Analysis of the Primary Efficacy Endpoint(s) 
The primary endpoint, proportion of overall pain intensity responders is defined as a subject 
whose daily abdominal pain intensity averaged over the 4 weeks of Phase 3 (weeks 13 through 
16) is 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks of 
Phase 1 (weeks -4 through -1) (27). Responders will be compared between the GDH and 
comparator treatment groups using a Cochran-Mantel-Haenszel test adjusted for IBS subtype and 
gender. If the resulting p-value is less than 0.05 and the magnitude of the difference in pooled 
proportions is at least 10 percentage points, then it will be concluded that the primary endpoint 
has been met. 
 
9.4.3 Analysis of the Secondary Efficacy Endpoint(s) 
 
9.4.3.1 Abdominal Pain Intensity 
Average abdominal pain intensity will be calculated as the average of the daily abdominal pain 
intensity scores recorded by each participant. Averages will be calculated for each week and for 
each 4-week assessment period (i.e., Phase 1 [Week -4 to -1,], Phase 3 [Week 13 – 16], etc.).  
Average abdominal pain intensity at Week 13-16 will be statistically compared between GDH 
and MR using an ANOVA model adjusted for gender and IBS subtype. The least squares (LS) 
mean estimate of average abdominal pain intensity and LS mean difference and associated 95% 
CIs will be presented with corresponding p-value. 
Additionally, change from baseline and at-assessment values of average abdominal pain intensity 
will be analyzed at all 4-week assessment time periods with a mixed effects repeated measures 
model (MMRM). The model will include treatment, time period, IBS subtype, gender, and 
treatment by time period interaction as fixed effects and participant as a random effect. The 
unstructured covariance matrix will be used to model the within-participant correlation. Using 
the ESTIMATE and LSMEANS statements within PROC MIXED, the model-based LS means 
and LS mean differences (GDH minus comparator) and associated 95% CIs for each time period 
and overall will be estimated.  

 
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Average abdominal pain intensity will be summarized descriptively by treatment and time 
period. 
 
Additionally, overall pain intensity response at all 4-week assessment time periods will be 
analyzed with a random effects generalized estimating equations (GEE) with a logit link. The 
model will include treatment, time period, IBS subtype, gender, and treatment by time period 
interaction as fixed effects and subject as a random effect. The unstructured covariance matrix 
will be used to model the within-subject correlation. Using the ESTIMATE and LSMEANS 
statements within PROC GLIMMIX, the model-based responder rates and odds ratio (GDH 
relative to comparator) and associated 95% CIs for each time period and overall will be 
estimated. 
 
9.4.3.2 Average Abdominal Pain Frequency 
Average abdominal pain frequency is defined as the average number of days during the 4-week 
assessment period in which the subjects recorded a 1 or greater on the daily pain severity 
measurement. Only days during which an assessment is recorded will be included in the 
calculation of average abdominal pain frequency.  
 
Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH 
and comparator using an ANOVA model adjusted for gender and IBS subtype. The least squares 
(LS) mean estimate of average abdominal pain frequency and LS mean difference and associated 
95% CIs will be presented with corresponding p-value. 
 
Additionally, change from baseline and at-assessment values of average abdominal pain 
frequency will be analyzed at all 4-week assessment time periods with a mixed effects repeated 
measures model (MMRM). The model will include treatment, time period, IBS subtype, gender, 
and treatment by time period interaction as fixed effects and subject as a random effect. The 
unstructured covariance matrix will be used to model the within-subject correlation. Using the 
ESTIMATE and LSMEANS statements within PROC MIXED, the model-based LS means and 
LS mean differences (GDH minus comparator) and associated 95% CIs for each time period and 
overall will be estimated.  
 
Average abdominal pain frequency will be summarized descriptively by treatment and time 
period. 
 
9.4.3.3 Stool Consistency  
Stool Consistency will be calculated using the BSFS. The BSFS is recorded at approximately the 
same time each day. Subjects will be asked for the number of bowel movements in the previous 

 
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24 hours. Subjects will use the BSFS to score the worst stool in the preceding 24 hour period. 
Extreme stool consistency is defined as 1, 2, 6, or 7 on the BSFS, while BSFS scores of 3,4 and 5 
are considered within the normal range. The BSFS scores will be grouped as 1,2 (Group 1), 3,4,5 
(Group 2) and 6,7 (Group 3). For participants in the IBS-D and IBS-M subtypes, a stool 
consistency response is defined as having a greater than or equal to 50% reduction from baseline 
(Phase 1) in the number of days with a BSFS score of 6 or 7.  Stool consistency response for the 
IBS-D and IBS-M subtypes will be analyzed with methods similar to those used to assess the 
primary endpoint described in Section 10.4.2. 
 
Additionally, change from baseline in the percentage of days with a BSFS score in Group 2 will  
will be analyzed at all 4-week assessment time periods with a mixed effects repeated measures 
model (MMRM). The model will include treatment, time period, IBS subtype, gender, and 
treatment by time period interaction as fixed effects and subject as a random effect. The 
unstructured covariance matrix will be used to model the within-subject correlation. Using the 
ESTIMATE and LSMEANS statements within PROC MIXED, the model-based LS means and 
LS mean differences (GDH minus comparator) and associated 95% CIs for each time period and 
overall will be estimated.  
 
The percentage of the number of days with a BSFS score in each BSFS group will be 
summarized descriptively by treatment, IBS subtype and time period. 
 
 
9.4.3.4 Stool Frequency 
Analyses of daily stool frequency will only include participants with IBS-C.   
Daily stool frequency will be calculated as the average number of stools per day during each 4-
week assessment period. Only days during which an assessment is recorded will be included in 
the calculation of average stool frequency.  
For participants in IBS-C subtype, a stool frequency response is defined as an increase from 
baseline (Phase 1) of >1 bowel movement per day. Stool frequency response for IBS-C 
participants will be analyzed with methods similar to those used to assess the primary endpoint 
described in Section 10.4.2. 
Change from baseline and at-assessment values of daily stool frequency will be analyzed at all 4-
week assessment time periods with a mixed effects repeated measures model (MMRM). Separate 
models will performed for each IBS subtype. The model will include treatment, time period, 
gender, and treatment by time period interaction as fixed effects and participant as a random 
effect. The unstructured covariance matrix will be used to model the within-participant 

 
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correlation. Using the ESTIMATE and LSMEANS statements within PROC MIXED, the model-
based LS means and LS mean differences (GDH minus comparator) and associated 95% CIs for 
each time period and overall will be estimated.  
Daily stool frequency will be summarized descriptively by treatment and time period. 
9.4.3.5 IBS-QOL 
The IBS-QOL is a 34-item questionnaire. The items are summed and transformed to a 0-100-
point scale. Higher scores indicate better IBS quality of life.  
 
Change from baseline and at-assessment values of IBS-QOL score measured at the Baseline 
visit, week 16, week 38, and week 64 will be analyzed with a MMRM. The model will include 
treatment, week, IBS subtype, gender, and treatment by week interaction as fixed effects and 
subject as a random effect. The unstructured covariance matrix will be used to model the within-
subject correlation. Using the ESTIMATE and LSMEANS statements within PROC MIXED, the 
model-based LS means and LS mean differences (GDH minus comparator) and associated 95% 
CIs for each week and overall will be estimated.  
 
IBS-QOL score will be summarized descriptively by treatment and week. 
 
9.4.3.6 Workplace Presenteeism and Absenteeism 
The Workplace Productivity and Activity Impairment Questionnaire (WPAI) is a 6-question 
survey of presenteeism and absenteeism and it will be measured at the Baseline visit, week 8, 16, 
38, and 64.  
 
Percent overall work impairment due to problem and percent activity impairment due to problem 
will be analyzed similarly to IBS-QOL. 
 
Percent work time missed due to problem, percent impairment while working due to problem, 
percent overall work impairment due to problem and percent activity impairment due to problem 
will be summarized descriptively by treatment and week. 
 
9.4.4 Exploratory Analyses 
The following exploratory endpoints will be detailed out in the statistical analysis plan. 
● PHQ-4 
● TIS 
● IBS-AR 
● Blinding question 
● Satisfaction questionnaire 

 
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● Treatment adherence 
● Concomitant medication usage 
 
9.4.5 Safety Analyses 
All AEs will be coded to System Organ Class (SOC) and Preferred Term using Medical 
Dictionary for Regulatory Activities (MedDRA). The number and percentage of subjects that 
experience at least one AE, grade 3-5 AEs, related AEs, SAEs, and related SAEs will be 
summarized by treatment group. Additionally, AEs will be summarized by severity and 
relatedness.  
 
9.4.6 Baseline Descriptive Statistics 
Demographic and baseline characteristics will be listed and summarized descriptively by 
treatment group. 
 
9.4.7 Planned Interim Analyses  
There are no planned interim analyses. 
 
9.4.8 Sub-Group Analyses 
The primary and secondary endpoint analyses will be conducted in the following subgroups: 
● Gender 
● IBS subtype 
● Age group (<=median, > median) 
● Concomitant medication 
o On IBS drug therapy vs not on IBS drug therapy 
o IBS-C on IBS drug therapy vs IBS-C not on IBS drug therapy 
o IBS-D on IBS drug therapy vs IBS-D not on IBS drug therapy 
Further details will be provided in the statistical analysis plan.  

 
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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 Regulatory, Ethical, and Study Oversight Considerations 
10.1.1 Informed Consent 
Written informed consent must be obtained from all subjects prior to entry into the study. 
Written consent documents will embody the elements of informed consent described in the 
Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all 
applicable laws and regulations. The informed consent form describes the planned and permitted 
uses, transfers, and disclosures of the subject’s personal and personal health information for 
purposes of conducting the study. The informed consent form further explains the nature of the 
study, its objectives, and potential risks and benefits, as well as the date informed consent are 
given. The informed consent form will detail the requirements of the subject and the fact that he 
or she is free to withdraw at any time without giving a reason and without prejudice to his or her 
further medical care. 
 
The PI/Sponsor is responsible for the preparation, content, and IRB approval of the informed 
consent form. The informed consent form must be approved by the IRB. The informed consent 
must be written in a language fully comprehensible to the prospective subject. It is the 
responsibility of the investigator or delegated staff to explain the detailed elements of the 
informed consent form to the subject. 
 
Curebase will use an electronic consent platform (eConsent) to facilitate the consent process. The 
eConsent will be introduced to subjects as part of an on-line pre-screening interview. The pre-
screening process requires subjects to create an account and login that allows ongoing access to 
their secure Curebase platform account. Once subjects pass their pre-screening they will be able 
to review the eConsent, HIPAA Authorization, and the Experimental Subjects’ Bill of Rights 
using their own personal electronic devices, like a phone, tablet, or computer. During the 
subject’s review they will be provided an opportunity to discuss the content of the eConsent with 
study personnel via email or telephone.  
 
Subjects will have the option to delay document signing and proceed to the study visit where 
they can further discuss the consent with the study physician prior to signing. Each subject will 
be required to electronically sign the study informed consent, HIPAA Authorization, and the 
Experimental Subjects’ Bill of Rights before they are allowed to participate in the study. After 
signing each document, subjects will be sent digital PDFs of their documents for their personal 
records. The original informed consent form will be stored in the eCRF. In the case of revisions 
to the informed consent form, subjects will be contacted and revised eConsent forms must be 
reviewed and signed by subjects. The date the revised consent was obtained will be recorded 
with the eConsent.  
 

 
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10.1.2 Study Discontinuation and Closure 
metaMe reserves the right to terminate or suspend the study at any time for any reason. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
● Determination of unexpected, significant, or unacceptable risk to subjects 
● Insufficient compliance to protocol requirements 
● Data that are not sufficiently complete and/or evaluable 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the sponsor, IRB, and/or Food and Drug Administration (FDA). 
 
10.1.3 Confidentiality and Privacy  
Subject confidentiality and privacy are strictly held in trust by the participating investigators, 
their staff, and the sponsor and their interventions. Therefore, the study protocol, documentation, 
data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior 
written approval of the sponsor. All research activities will be conducted in as private a setting as 
possible. 
 
Curebase, Inc. will prepare and maintain adequate and accurate electronic source documents 
designed to record all observations and other pertinent data for each subject screened or enrolled 
in the study. All data from subjects will be collected, managed, and securely stored by Curebase. 
Curebase stores all data in a secure cloud server (AWS) and complies with HIPAA and GDPR 
standards, including but not limited to: password protection, platform encryption, and 2-factor 
verification. Curebase takes as much action as possible to maximize the protection and security 
of subject’s sensitive information. In order to maintain subject confidentiality, subjects will not 
be identified by name in any reports or study documents to be collected by the Sponsor (or 
designee), but will be identified by a clinic number and subject number. 
 
metaMe Health, Inc. will collect and store PHI. This information is needed to correctly target 
treatment notification, treatment reminders, and to administer the treatment. There will be no 
data link between PHI and treatment allocation or data used to determine treatment compliance 
(see Section 6.3). metaMe Health stores all data in a secure cloud server (AWS) and complies 
with HIPAA and GDPR standards, including but not limited to password protection and platform 
encryption. To maintain subject confidentiality, subjects will not be identified by name in any 
reports or study documents to be collected by the Sponsor (or designee), but will be identified by 
a clinic number and subject number. 
 
Refer to Section 10.1.6 for additional information on how data will be collected and secured. 
 
10.1.4 Clinical Monitoring 
Curebase will provide clinical monitoring during the study to ensure that:  

 
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1. The rights and well-being of human subjects are protected 
2. The reported study data are accurate and complete 
3. The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), with GCP, and with the applicable regulatory requirements. 
 
Refer also to Sections 11.1.5 and 11.1.6 for additional details. 
 
10.1.5 Quality Assurance and Quality Control 
Quality control (QC) procedures will be implemented beginning with the data entry system. Data 
QC checks will be remotely run on the database and shall be generated on an ongoing basis to 
verify the accuracy and integrity of data being collected. Any missing data or data anomalies will 
be communicated to the investigators for clarification and resolution. 
 
Following written standard operating procedures (SOPs), the monitor will verify that the clinical 
study is conducted and data are generated, documented (recorded), and reported in compliance 
with the protocol, ICH GCP and applicable regulatory requirements.  
 
The investigators will provide direct access to all study related records, source data/documents, 
and reports for the purpose of monitoring and auditing by the sponsor, and inspection by the 
relevant regulatory authorities. 
 
10.1.6 Data Collection, Retention, and Monitoring 
Investigators and their representatives will be required to complete a training on using the 
Curebase platform prior to working with subjects. Training material will include instructions on 
how to enter data correctly, how to enter protocol deviations and AEs, and how to modify and 
update the eCRF. Training of investigators and research personnel will be tracked by Curebase 
using study-specific activation logs. Following written SOPs, the study monitors will verify that 
the clinical study is conducted and data are generated, documented, and reported in compliance 
with the protocol, ICH GCP, and applicable regulatory requirements. 
 
Study personnel will enter data collected during the baseline visit into the Curebase eCRF. If a 
correction is required for a subject’s eCRF, the time and date stamp tracks the person entering or 
updating eCRF data and creates an electronic audit trail. The Investigators and Curebase are 
responsible for all information collected on subjects enrolled in this study.  
 
Curebase will provide clinical monitoring during the study to ensure that:  
1. The rights and well-being of human subjects are protected 
2. The reported study data are accurate and complete 
3. The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), with GCP, and with the applicable regulatory requirements. 

 
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4. Correct coding of AEs, medical history, and concurrent medical conditions using the 
Medical Dictionary for Regulatory Activities (MedDRA). Drugs will be coded using the 
World Health Organization Drug Dictionary (WHO). 
 
10.1.6.1 Data Collection Instruments 
Curebase will provide eCRFs to each subject who signs an informed consent and completes the 
clinic visit screening. These forms are used to transmit the information collected in the 
performance of this study to sponsor and regulatory authorities. After completion of the entry 
process, computer logic checks will be run to identify items, such as inconsistent dates, missing 
data, and questionable values. Queries may be issued by the PI or designees and will be 
addressed by the clinic research staff. The PI must review the eCRFs for completeness and 
accuracy and must e-sign the appropriate eCRFs as indicated. Furthermore, the investigator must 
retain full responsibility for the accuracy and authenticity of all data entered on the eCRFs. The 
completed eCRFs are the sole property of the sponsor and should not be made available in form 
to third parties, except for authorized representatives of appropriate governmental regulatory 
authorities. 
 
Investigators and their representatives will be required to complete a training on using the 
Curebase platform prior to working with subjects, including how to enter data correctly, how to 
enter protocol deviations and AEs, and how to correct mistakes. Trainings will be tracked by 
Curebase on study-specific activation logs. Following written SOPs, the study monitors will 
verify that the clinical study is conducted and data are generated, documented, and reported in 
compliance with the protocol, ICH GCP, and applicable regulatory requirements. 
 
Study personnel at each research clinic will enter data corresponding to a subject’s visit into the 
protocol-specific eCRF. If a correction is required for an eCRF, the time and date stamps track 
the person entering or updating eCRF data and creates an electronic audit trail. The Investigator 
is responsible for all information collected on subjects enrolled in this study. All data collected 
during the course of this study must be reviewed and verified for completeness and accuracy by 
the Investigator. 
 
10.1.6.2 Data Management Procedures 
All data will be entered into Curebase, which is a validated database. The Curebase team or 
delegate will be responsible for data processing, in accordance with procedural documentation. 
Database lock will occur once quality assurance procedures have been completed. All procedures 
for the handling and analysis of data will be conducted using good computing practices meeting 
FDA guidelines for the handling and analysis of data for clinical trials. 
 

 
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10.1.6.3 Data Quality Control and Reporting 
Quality control (QC) procedures will be implemented beginning with the data entry system. 
After the data has been entered into the Curebase database, a system of computerized data 
validation checks will be implemented and applied to the database every 2 weeks. Query reports 
pertaining to missing data or data discrepancies will be forwarded to the Investigators, clinical 
team and study monitors for clarification/resolution. A Curebase representative will follow up to 
ensure that the corrections are completed and documented appropriately. The study database will 
be updated in accordance with the resolved queries. Following completion of the study data 
collection, Curebase will provide a thorough quality control review of all records. Finalized data 
will then be designated for database lock prior to statistical analysis. In addition, following 
written standard operating procedures (SOPs), the monitor will verify that the clinical study is 
conducted and data are generated, documented (recorded), and reported in compliance with the 
protocol, ICH GCP and applicable regulatory requirements.  
 
The investigators will provide direct access to all study related records, source data/documents, 
and reports for the purpose of monitoring and auditing by the sponsor, and inspection by the 
relevant regulatory authorities. 
 
10.1.6.4 Archival of Data and Record Retention 
The database is safeguarded against unauthorized access by established security procedures. 
Appropriate backup copies of the database and related software files will be maintained. 
Databases are backed up by the Curebase database administrator in conjunction with any updates 
or changes to the database. 
 
At critical junctures of the protocol (e.g., production of interim reports and final reports), data for 
analysis are locked and cleaned per established procedures.  
 
All data pertaining to a clinical study, including protected health information (PHI), will be 
retained for the duration of the study, and for 2 years thereafter, in compliance with International 
Conference on Harmonisation (ICH) E6 Section 4.9.5 and specified in ICH E6 (Section 8) until 
at least 2 years after the last approval of a marketing application for a specified treatment being 
investigated or, if an application is not approved, until at least 2 years after the investigation is 
discontinued and regulatory authorities are notified. In addition, ICH E6 Section 4.9.5 states that 
the study records should be retained until an amount of time specified by applicable regulatory 
requirements or for a time specified in the agreement between the investigator and sponsor. At 
this point, the identifiable PHI obtained during the study will be deleted. Curebase will share 
pseudonymized data collected from subjects with metaMe Health Inc. 
After 2 years have elapsed since the completion of a clinical investigation, Curebase will retain a 
de-identified version of the data obtained during that study. Curebase may retain these data 
indefinitely and may use them for a variety of purposes that will include, but are not be limited 

 
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to, making improvements to the Curebase product. MetaMe Health will be permitted to retain the 
pseudonymized Curebase data set, even after the 2-year post-study period has elapsed. 
 
Curebase will not delete clinical data, even upon request, during the clinical study and for 2 years 
thereafter. Although Curebase respects the rights of its users to be forgotten, Curebase is also 
bound by an obligation to deliver study data to the Sponsor for scientific analysis, and to fulfill 
monitoring obligations. 
 
MetaMe Health reserves the right to keep the pseudonymized data retrieved from Curebase for 
the entire duration the company is functioning and active. MetaMe Health will keep this 
information in a private and secure internal database. 
 
10.1.6.5 Monitoring 
Electronic monitoring visits will be conducted by representatives of Curebase, Inc according to 
the U.S. CFR Title 21 Parts 50, 56, and 312 and ICH Guidelines for GCP (E6). Study 
investigators will provide direct access to all clinical records, study source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. By signing this protocol, the Investigator grants permission to Curebase 
and appropriate regulatory authorities to conduct monitoring and/or auditing of all appropriate 
study documentation. 
 
10.1.6.6 Protocol Deviations  
A protocol deviation is any noncompliance with the clinical study protocol and ICH GCP 
requirements. The noncompliance may be either on the part of the subject, the investigator, or the 
study research staff. As a result of deviations, corrective actions are to be developed by the study 
physicians and implemented promptly.  
 
These practices are consistent with ICH GCP:  
● 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
● 5.1 Quality Assurance and Quality Control, section 5.1.1  
● 5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the study physicians and study monitors to use continuous vigilance to 
identify and report deviations within 10 working days of identification of the protocol deviation, 
or within 10 working days of the scheduled protocol-required activity. All deviations must be 
categorized as either significant or minor. Significant deviations are those events that cause or 
could cause harm to subjects or others or that affect the fidelity of the research.  Curebase will 
maintain a database of protocol deviations for the duration of the study and shall be responsible 
for triaging report writing and internal documentation. Significant protocol deviations will be 

 
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sent to the reviewing Institutional Review Board (IRB) per their policies. The study physicians 
and study monitors are responsible for knowing and adhering to the reviewing IRB requirements.  
 
10.1.6.7 Clinical Trial Results Disclosure 
metaMe will post the results of clinical trials on ClinicalTrials.gov and/or other publicly 
accessible websites, as required by metaMe policy/standard, applicable laws, and/or regulations. 
 
10.1.6.8 Publication and Data Sharing Policy 
Curebase will provide metaMe with all data collected during the study. After study completion, 
only metaMe may make study information available to other study investigators or to regulatory 
agencies, except as required by law or regulation. Except as otherwise allowable in the clinic 
research agreement, any public disclosure (including publicly accessible websites) related to the 
protocol or study results, other than study recruitment materials and/or advertisements, is the sole 
responsibility of the sponsor. metaMe reserves the right to publish any data from the study 
without the consent of investigators. Manuscript authorship for any peer-reviewed publication 
will appropriately reflect contributions to the production and review of the document. 

 
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11 REFERENCES 
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quality of life. Rev in Gastro Dis. 2013(2):S3-S11. 
2. Ford AC, Bercik P, Morgan DG, Bolino C, Pintos-Sanchez MI, Moayyedi P. Validation 
of the Rome III criteria for the diagnosis of irritable bowel syndrome in secondary care. 
Gastroenterology. 2013(145):1262-70. 
3. Leong SA, Barghout V, Birnbaum HG. The economic consequences of irritable bowel 
syndrome: A US employer perspective. Arch Intern Med. 2003(163):929-35. 
4. Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome. 
A meta-analysis. Clin Gastroenterol Hepatol. 2012(10):712-21. 
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participants with Irritable bowel syndrome in the United States. PLOS One. 2016 
(http://DOI:10:1371/journal.pone.0154258 ).  
6. Mayer EA, Tillisch K. The Brain-Gut Axis in abdominal pain syndromes. Ann Rev of 
Medicine. 2011(62):381-96. 
7. Lackner JM. The role of psychosocial factors in functional gastrointestinal disorders. 
Quigley, Hongo, Fukuda (eds): Functional and GI Motility Disorders. 2014(33):104-16. 
8. Camilleri M, Ford AC. Pharmacotherapy for irritable bowel syndrome. J Clin Med. 
2017(6):101. (http://dx.doi:10:3390/jcm6110101)  
9. Blanchard EB, Greene B, Scharff L, Schwarz-McMorris SP. Relaxation training as a 
treatment for Irritable Bowel Syndrome. Biofeedback and Self Regul. 1993;18:125-132. 
10. Palsson O. Hypnosis treatment of gastrointestinal disorders: A comprehensive review of 
the empirical evidence. Am J of Clinical Hypnosis. 2015(58):134-58. 
11. Lackner JM, Jaccard J, Keefer L, Brenner DM, Firth RS, Gudleski GD, et al. 
Improvement in gastrointestinal symptoms after cognitive behavior therapy for refractory 
irritable bowel syndrome. Gastroenterology. 2018(155):47-57. 
12. Flik CE, Laan W, Zuithoff NPA, van Rood YR, Smout A, Wuesten B, et al. Efficacy of 
individual and group hypnotherapy in irritable bowel syndrome (IMAGINE): a 
multicenter randomized controlled trial. Lancet Gastroenterol Hepatol. 2018 
(http://dx.doi.org/10.1016/S2468-1253(18)30310-8) 
13. Drossman D, Camilleri M, Mayer EA, Whitehead WE. AGA Technical review on 
irritable bowel syndrome. Gastroenterology. 2002(123):2108-31.  
14. Yeh et al. Disseminating hypnosis to health care settings: Applying the RE-AIM 
framework. Psychol Conscious (Am Psychol Assoc). 2014(2):213-28.  
15. Gonsalkorale K, Miller V, Afzal A, Whorwell PJ. Long term benefits of hypnotherapy 
for irritable bowel syndrome. Gut. 2003(52):1623-29. 

 
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16. Lowen MBO, Myer EA, Sjoberg M, Tillisch K, Naliboff B, Labus J, et al. Effect of 
hypnotherapy and educational intervention on brain response to visceral stimulus in the 
irritable bowel syndrome. Aliment Pharmacol Ther. 2013(37):1184-97. 
17. American Psychiatric Association: Diagnostic and Statistical Manual of Mental 
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18. Powell RA, Gee TI. The effects of hypnosis on dissociative identity disorder: A 
reexamination of the evidence. Can J Psychiatry. 1999(44):914-916. 
19. Myerson J, Konichezy MA. Out-of-illness experience: Hypnotically induced dissociation 
as a therapeutic resource in treating people with obstinate mental disorders. Amer J of 
Psycho. 2009(63):133-146. (Https://doi.org/10.1176/appl.psychotherapy.2009.63.2.133) 
20. Hauser W, Hagl M, Schmierer A, Hansen E. The efficacy, safety and applications of 
medical hypnosis. Dtsch Arztebl Int. 2016(113):289-96. 
21. Patrick D, Drossman D, Frederick I, Dicesare J, Puder K: Quality of life in persons with 
irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci 
1998, 43:400–411. 
22. Reilly MC, Zbrozek AS, Dukes E: The validity and reproducibility of a work 
productivity and activity impairment measure. PharmacoEconomics 1993; 4(5):353-365. 
23. Palsson OS. Development and validation of the Thought Impact Scale: A measure of 
subconscious connectedness. American Journal of Clinical Hypnosis 2019 (in press). 
24. Kroenke K, Spitzer RL, Williams JBW, Löwe B. An ultra-brief screening scale for 
anxiety and depression: the PHQ-4. Psychosomatics 2009;50:613-621. 
25. Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of 
statistical methods and a proposal of blinding assessment protocol. Clin Res and Reg 
Affairs, 2010;27(2):42-51 
26. Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 
31;12:1178224219826581. doi: 10.1177/1178224219826581. 
27. Palsson O. Standardized hypnosis treatment for irritable bowel syndrome: The North 
Carolina protocol. Int J Clin Exp Hyp. 2006(54):51-64. 
28. Food and Drug Administration. Guidance for Industry: Irritable Bowel Syndrome. 
https://www.fda.gov/media/78622/download, accessed July 2019. 
29. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand 
J Gastro. 1997; 32:920–924. 
30. Palsson OS, Baggish JS, Turner MJ, Whitehead WE. IBS patients show frequent 
fluctuations between loose/watery and hard/lumpy stools: implications for treatment. Am 
J Gastroenterol. 2012 Feb;107:286-95.  
 

 
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APPENDIX A ROME IV CRITERIA 
Question 
Answer 
1. In the last 3 
months, how often 
did you have pain 
anywhere in your 
abdomen?  
0. Never (Skip to end of questionnaire)  
1. Less than one day a month  
2. One day a month  
3. Two to three days a month   
4. Once a week  
5. Two to three days a week  
6. Most days  
7. Every day  
8. Multiple times per day or all the time 
2. How often did this 
pain in your abdomen 
happen close in time 
to a bowel movement 
-- just before, during, 
or soon after? 
(Percent of times 
with pain) 
0. %0 or Never   
1. 10%   
2. 20%   
3. 30%    
4. 40%   
5. 50%   
6. 60%   
7. 70%   
8. 80%   
9. 90%   
10. 100% 
3. How often did 
your stools become 
either softer than 
usual or harder than 
usual when you had 
this pain? (Percent of 
times with pain) 
0. %0 or Never   
1. 10%   
2. 20%   
3. 30%    
4. 40%   
5. 50%   
6. 60%   
7. 70%   
8. 80%   
9. 90%   
10. 100% 
4. How often did 
your stools become 
either more frequent 
than usual or less 
frequent than usual 
when you had this 
0. %0 or Never   
1. 10%   
2. 20%   
3. 30%    
4. 40%   
5. 50%   

 
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pain? (Percent of 
times with pain) 
6. 60%   
7. 70%   
8. 80%   
9. 90%   
10. 100% 
5. Has it been 6 
months or longer 
since you started 
having this pain? 
0. No 
1. Yes 
 
Rome IV Scoring 
Irritable Bowel Syndrome 
Must fulfill the following criteria for the past 3 months:  
1. Recurrent abdominal pain  
Q1 = at least weekly  
2. Pain is associated with two or more of the following criteria:  
a. Related to defecation  
Q2 = at least 30% of occasions  
b. Associated with a change in frequency of stool  
Q3 = at least 30% of occasions  
c. Associated with a change in form (appearance) of stool  
Q4 = at least 30% of occasions  
1. Symptom onset at least 6 months prior to diagnosis  
Q5 = yes  
 
APPENDIX B  GUT-DIRECTED HYPNOTHERAPY SESSION SCRIPTS 
IBS Session One 
Now please make yourself as comfortable as you can in your chair. Find a relaxed position so 
that you can sit comfortably and with minimum effort and without having to move around. Just 
try to make yourself as comfortable as you can and sit in a relaxed position. 
I would like to ask you to look up at the ceiling and find a spot there to look at. It doesn't matter 
what spot it is. Just find one spot or place in the ceiling to look at. And keep your eyes on that 
spot for a little while, as we start this relaxation exercise. In a moment I am going to start 
counting to three, and I would like to ask you to keep looking up at the spot while I count. With 
each number of the count, your eyelids may become heavier and start to push down and close. 
However, some people's eyes do not close as quickly as those of others - and it is possible that it 
might not happen in your case. And that is all right. There is no need to be concerned if that does 

 
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not happen to you. It does not matter. Different people respond differently. Should your eyelids 
not begin to push down more and more and close as I count to three, then you can just close them 
a little later when I tell you to do so. The important thing is that just allow whatever is going to 
happen to take place. Keep yourself open to experiencing whatever you can without resisting it. 
You do not really have to help it along, either. All you have to do is simply to concentrate on the 
things that I talk about and to allow things to happen. But as I said, your eyelids will probably 
quickly become very heavy and start closing by themselves as I count to three. And when you 
feel that heaviness come into your eyelids - when they feel ready to close, just allow it to happen 
by itself. As I begin the count, just let go and relax, allowing yourself to experience whatever is 
going to happen. That is the best way to enjoy hypnosis. 
Keep looking at the spot in the ceiling ... that's right ... ... and keep your eyes still like that ... 
keep them up there, focused on the spot. Good. Focus your attention on the spot and pay close 
attention to what I am going to say: As you keep looking at the spot, allow your whole body to 
begin to relax - just by thinking about it, relaxing. Relax your body and keep looking at the spot, 
concentrate on it. Relax your whole body, allow it to be limp and heavy and relaxed, ... limp ... 
and heavy ... and relaxed. Notice if you can feel the tension leave your muscles ... and notice 
how your body becomes more limp and heavy. Just relax and keep focusing on the spot and 
listening to my voice. And as you relax your body, as you let go more and more... you will soon 
notice that your eyelids also begin to feel heavy ... heavier... and heavier... Just concentrate on 
the spot in the ceiling and on my voice. One. Heavier ... and heavier. Your eyelids may already 
be pushing down, sinking down under their own heavy weight, sinking down ... as heavy as large 
shields made of lead, heavy as lead ... as you let go ... as you let go and relax, your eyelids 
become heavier ... perhaps they are already beginning to push down ... feel the heaviness in your 
eyelids as you allow yourself to relax more and more ... relax more and more ... becoming heavy 
and relaxed, comfortably heavy and relaxed ... two ... you can try to keep staring at the spot a 
little bit longer, but it may be getting very difficult, as your eyelids are becoming sooo heavy, too 
heavy for that, and your eyes may be beginning to close already. For some people this happens 
quickly, for others it happens more slowly ... but the eyelids become heavier and heavier. Pay 
attention to your eyelids ... and as you concentrate on them you probably become more aware of 
them than you usually are, ... you may even be more aware of the feeling in your eyelids than 
you have ever been before ... feel how heavy and tired your eyelids are ... and as you do, you 
probably notice that they are getting still heavier, still heavier ... they sink down and close all by 
themselves, under their own heavy weight ... three, your eyes want to close as you just let go and 
relax, heavier ... closing ... heavier and heavier, feel them getting heavier, ... closing all by 
themselves ... closing all by themselves ... closing ... closing now. Allow your eyes to close now 
... just let them close. 

 
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There is no need to strain your eyes any longer. It is so much more comfortable just to close 
them and let go. You can close your eyes now and relax. Close your eyes now and let go and 
relax. 
That's good ... Eyes completely closed. You can just keep your eyes closed until I tell you to 
open them. It is easier to relax now that your eyes are closed. Just continue to listen to my voice 
and relax ... Relax and focus on what I am saying to you ... Relax your right hand ... allow all the 
muscles in your right hand to become completely limp and relaxed ... completely limp and 
relaxed ... Your right hand becomes completely relaxed as you think about the muscles in the 
hand relaxing... your right hand becomes completely relaxed ... and let that relaxation spread up 
your arm ... relax your left hand, too ... relax your left hand also ... concentrate on each part of 
your body as I talk about it. Maybe you can even picture it, see it in your mind even though your 
eyes are closed, see in your mind your body relaxing more and more ... relax your left hand ... 
notice the growing feeling of relaxation in your left hand as it spreads up your left arm, relaxing 
the arm also ... allow all of the muscles to become limp and soft and smooth ... limp and soft and 
smooth. Both of your hands and both arms are gradually becoming more and more relaxed, limp 
and relaxed ... limp and relaxed. Now relax your shoulders ... and your neck ... relax all the 
muscles in your shoulders and in your neck ... except those that are needed to keep you in a 
comfortable position ... Relax your shoulders ... relax your shoulders ... your shoulders can 
become soft and loose ... soft and loose ... and allow the relaxation to spread down your body ... a 
wave of relaxation washes down your body ... all the way down your body, relaxing every part of 
your body ... all the way down into your feet. All the way down your body. Your whole body 
relaxes more and more ... more and more ... allow your whole body to become limp and loose 
and relaxed. Relax your left foot even more ... your left foot is limp and heavy and comfortably 
relaxed ... and your left leg ...relaxed ... and now your right foot ... and your right leg ... Relax 
your whole body. 
You are breathing more and more freely and deeply now as your body relaxes, you breathe freely 
and deeply. Allow your whole body to relax. Relax your whole body. As we continue, your body 
will perhaps begin to feel a little numb ... and it may also feel heavier and heavier ... But this will 
be a comfortable feeling of heaviness and numbness ... On the other hand, your body may begin 
to feel lighter, as if it were weightless, and you might experience a sensation of floating. No 
matter what happens, whether you become heavy or light, whether you feel like you are floating 
or gently sinking, it will be an enjoyable and pleasant feeling that goes along with a state of deep, 
comfortable relaxation. 
In this relaxed state, your mind and your thoughts also become more relaxed and quiet. While 
you are in this state, there is no need to care about what is going on around you ... it is easier just 
to withdraw and turn your attention inside ... nothing is important now except enjoying relaxing 
and listening to what my voice is saying to you. Nothing else matters right now ... not a care or 
concern in the world ... this is an opportunity to just let go and enjoy a deep, carefree and 

 
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comfortable state of relaxation. Allow yourself to turn inside, to just drift completely away from 
all the cares and concerns of the world. You can perhaps become like an island ... undisturbed 
and beautiful and far away from the world. All you have to do is to relax and listen to my voice 
... Even my voice may soon begin to feel like it is coming to you from a distance ... and that's 
fine. But no matter how deeply hypnotized or relaxed you will feel yourself become, you will 
always continue to hear me, and my words will continue to affect you like in an automatic way. 
You are going to become even more relaxed ... still more relaxed, as we continue. I would like 
you to realize however, that you will be able to shift in your seat or to put your head in a more 
comfortable position if you need to, and this will not disturb your concentration or relaxation at 
all, and you will continue to be in the hypnotic state until I tell you to wake up. 
As you may know, people are better able to imagine things and picture things in their minds 
when they are in a relaxed state ... like you are now. I would like you now to picture something 
in your mind. Picture a staircase ... see yourself standing at the top of a grand staircase that goes 
down in front of you ... a grand staircase covered with a thick and luxurious red carpet... 
Concentrate on this and see it clearly in your mind. This is a strong marble staircase with twenty 
steps, covered with a luxurious, thick, soft, red carpet. Imagine yourself standing barefoot at the 
top of this staircase ... and feel the softness and the warmth of the carpet under your feet ... it is 
so thick that your feet sink deeply into it. Feel it now under your feet, so soft and thick ... At the 
right side of the staircase there is an old, strong wooden banister going all the way down. You 
might want to reach out in your mind and touch the banister with your fingers. Feel how hard 
and solid the wood is, polished smooth by many hands ... You also notice, as you stand there at 
the top of the staircase, that next to the banister, the marble steps are not covered by the carpet. 
Just out of curiosity, you might want to put your foot out to the right for a moment, in your mind, 
and touch the marble there at the top of the staircase. Touch the marble on the side of the 
staircase with your foot. Feel how cool and hard and smooth it is ... so cool and hard and smooth 
under your foot... and notice how this feeling contrasts with the softness and the warmth of the 
carpet as you put your foot back on it. 
Now you will start to go down this staircase as I count each step. And as you go down the stairs, 
your body can automatically relax more and more all over with every number. And at the same 
time, you will probably find your mind quieting down into a comfortable focused and relaxed 
hypnotic state more and more with every step you take down.... One, take the first step down, 
and feel the wonderful softness of the carpet under your feet as you stand there on the first step 
below ... As I continue to count, you will go down one step further with each number, and at the 
same time going deeper and deeper into the hypnotic state effortlessly and automatically. Deeper 
and deeper with every number. Not everyone sees things as clearly in their mind. And it is all 
right if you do not see the staircase very clearly, you will still continue to go deeper and deeper 
into the hypnotic state with each number I count up to twenty. Whatever you experience is fine. 
But most likely, you can see the steps clearly in front of you going down, covered by the rich, 

 
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velvety carpet, and you can probably see how the color of the carpet on the steps in front of you 
becomes deeper and deeper with each step down. A deeper and more restful color with each step 
you take. Two, now you take another step down ... three, deeper down, further down into a 
relaxed and comfortable state of hypnosis ... four ... five, further down, deeper down ... six, just 
let go more and more, more and more at ease ... seven ... eight, your feet sink into the soft and 
comfortable carpet with each step down, as you sink deeper into a deep and restful hypnotic state 
... nine ... ten, always more and more down, further down, as you relax more and more deeply ... 
eleven ...your body more at ease and your mind more at peace, twelve ... thirteen ... fourteen ... 
fifteen ... you go on deeper down, still deeper down into a safe and comfortable state of hypnosis 
... sixteen ... seventeen ... you can see the bottom of the stairs now if you look down ... the floor 
below is covered by the same soft and comfortable carpet ... this is a place deep in your mind ... a 
place of rest, relaxation, and comfort ... eighteen, ... nineteen, only one more step and you will be 
there, in a place of deep comfort and relaxation ... twenty! You take the last step down, down 
onto the carpeted floor. Let your whole body relax. Just allow your whole body to let go and 
relax completely ... Relax completely, and listen to my words. 
As you sit and relax and allow your whole body to be at ease, something positive and healthy 
and powerful is beginning to happen inside you. Your intestines are becoming much less 
sensitive to pain and discomfort, as a healthy, soothing wave of change spreads deep inside your 
body. Perhaps you can picture this in your mind now ... maybe you can picture these changes in 
your mind like a wave of medication that spreads down from your stomach and all the way down 
through your intestines, coating your intestines with a strong protective coating ... a coating that 
protects you from discomfort inside. Maybe you can feel a sense of healthy soothing comfort that 
spreads all through your intestines, making them less and less sensitive to irritation and pain. Or 
perhaps you picture this wave of healthy soothing change as a wave of light inside you... or 
maybe you even feel it inside you like a wave of comfortable warmth spreading down from your 
stomach all through your intestines. But regardless of the way you experience it, the effect of it is 
like your intestines are being coated ... coated completely inside with a healthy and strong 
protective coating ... a strong protective coating that makes them immune to irritation, and 
protects you from being upset inside. This strong protective coating lets only the pleasant 
sensations get through. 
These pleasant and healthy changes are beginning to happen inside your body right now - and 
they will continue steadily after you wake up from this hypnotic state in a little while - these 
changes will improve your health and well-being more and more from this day, more and more 
every day. You may - or you may not - notice these changes immediately, but they will come 
even when you do not pay any attention to them. Your stomach and intestines will feel less and 
less sensitive to discomfort, always less and less sensitive, and more and more comfortable, from 
one day to the next, beginning right now, today, until you are able to enjoy healthy comfort 
inside all the time. It will probably feel like this strong protective coating inside your intestines is 

 
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taking hold more and more over the coming days and weeks, always making you more and more 
comfortable and healthy inside. 
Of course, you would still be able to feel discomfort if your body really needed to warn you to 
protect you from serious harm. But you will become much less sensitive to irritation and 
discomfort in your intestines and stomach from now on. You will most likely be surprised to 
discover that things that would have irritated your stomach and intestines before do not feel 
uncomfortable to you anymore from now on ... and you will probably find that in situations 
where you would have felt pain in your bowels before, you now experience pleasant sensations. 
In a moment, I am going to start counting slowly down from twenty to one, and when I get down 
to the count of one, you will be fully awake and in a normal wakeful state. You will feel rested 
and refreshed and will not have any negative or uncomfortable aftereffects. But each time from 
now on that I ask you to look up into the ceiling in the beginning of each hypnosis session, your 
eyelids will immediately begin to feel very heavy, and your eyes will quickly close by 
themselves and you will fall into a deep hypnotic state. All right, now please picture yourself 
again in your mind at the bottom of the staircase with the thick, velvety carpet, standing again on 
the soft and comfortable carpeted floor. I am now going to begin to count down from twenty, and 
with each number you take a step up the staircase. When you reach the top, that is, when I have 
counted down to one, you will be fully awake, alert and feeling fine, with your eyes open. 
Twenty ... now you take the first step up the stairs ... nineteen ... another step up the stairs ... 
eighteen ... <CONTINUE SLOW COUNT BACKWARD> ... three ... now you are close to 
waking up ... two ... you are about to wake up ... and one ... you wake up and open your eyes 
now. Wide awake! Fully awake. 
 
IBS Session Two 
Now please make yourself comfortable in your chair, resting your hands in your lap. Find a 
position that you can keep comfortably with minimum effort. Good. In a moment I am going to 
ask you once again to find a spot on the ceiling and just concentrate on it. But first, take a deep 
breath, a very deep breath, inhale ... and hold your breath ... hold it ... and exhale very slowly, 
and as you do, relax your body ... That's right. Now we are ready to begin. 
All right, now look at the spot in the ceiling ... keep looking at it, concentrate on it and listen to 
my words ... and at the same time relax your whole body ... let your body become limp and 
heavy ... and soon, as I count from one to three, your eyelids will become heavier and heavier, 
one ... they become heavier and heavier ... feel the heaviness in your eyelids, they become heavy 
as if they are made of lead as I continue the count ... keep relaxing your body, making it limp and 
heavy, and keep staring at the spot if you can ... but your eyelids may just be getting too heavy 
for that ... sooo heavy ... and they may already be pushing down, pushing down and closing as I 
count to three, heavier and heavier with each number ... two ... relax your whole body, allowing 

 
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it to become heavy and limp and relaxed ... heavy and limp and relaxed ... heavy ... and limp ... 
and relaxed ... your eyelids share in that heaviness, becoming heavier and heavier ... heavier and 
heavier ... feel the heaviness in your eyelids, focus on the feeling in your eyelids, your eyelids 
start to push down, on their own, down more and more, more and more down, sooo heavy, heavy 
as lead ... heavy as lead. They begin to push down more and more to close ... and three ... your 
eyes want to close now, you can just allow it to happen, closing ... closing ... there is no reason to 
fight it or resist it, it is so much more comfortable to have your eyes closed ... they are so heavy 
and tired ... so heavy and tired ... closing, closing ... 
There is no need to strain your eyes more. You can just close your eyes now. Eyes completely 
closed. Just close your eyes and let go. Good. Now I would like to ask you to concentrate your 
thoughts on your hands and listen to my words. Focus your attention on your hands. As you 
concentrate your attention on your hands, you become more aware of them than you ordinarily 
are ... you can feel them more ... As your hands rest there on your lap, notice any sensations that 
you have in your hands ... are they warm or cold? ... are they light or heavy? 
... are they tense or relaxed? ... and while you are paying such close attention to your hands ... 
allow all the muscles in your hands to relax ... feel all the muscles in your hands becoming softer 
and more relaxed... softer and more relaxed ... more and more relaxed ... soft and loose and 
relaxed ... and also relax all the muscles in your forearms, allow all the muscles in your forearms 
to become soft and relaxed... relax every muscle in your forearms ... and upper arms, too, let all 
the tension leave your arms and hands completely, allow them to be limp, and heavy and loose, 
limp and loose ... heavy and limp. Let your arms rest, heavy and comfortably limp. 
Now focus your attention on your shoulders ... let the relaxation spread from your arms into your 
shoulders, making the muscles of your shoulders loose and soft and relaxed. Your shoulders 
relax more and more ... And let the relaxation spread on further now, down your body from the 
shoulders. It may feel as if waves of relaxation are washing down your body ... wave after wave 
... with each breath you take you relax more and more ... wave after wave ... breath after breath ... 
you breathe freely ... and deeply ... freely and deeply ... let the waves of relaxation sweep down 
your whole body with each breath you take, all the way down your body, relaxing your whole 
body more and more ... more and more ... relax your chest ... relax your stomach ... relax your 
buttocks and thighs ... allow the relaxation to spread all over your body ... down into your legs ... 
your legs become heavy and limp ... heavy and limp ... and your feet relax also ... relax your feet 
more and more ... your right foot completely relaxed ... relax your right foot completely ... and 
now allow your left foot to also become totally relaxed ... the left foot also comfortably relaxed. 
Your whole body becomes comfortably relaxed. Your whole body continues to become more 
and more relaxed as I continue to talk. 
I am now going to count slowly from one to twenty. With each number in the count, you will 
find yourself going down deeper and deeper into a deep and comfortable and relaxing hypnotic 

 
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state. Maybe you can imagine yourself sitting on a soft and comfortable cloud, sinking gently 
down, deeper and deeper with each number in the count. One ... you sink down, deeper into the 
hypnotic state as you relax more and more... two... deeper and deeper... three... four... five... 
deeper into the hypnotic state... there is nothing to worry about right now, not a care or concern 
in the world... six... you go on still deeper... seven... eight, deeper down... nine... ten... there are 
no troubles to bother you now ... you are drifting far away from all the worries and concerns of 
the world... drifting down, sinking safely and comfortably down into a carefree and comfortable 
state of hypnosis, eleven... twelve... a state in which you are probably able to picture things more 
clearly and vividly in your mind than you ordinarily can... thirteen... fourteen... you go still 
deeper... fifteen... sixteen... seventeen... deeper and deeper... eighteen... and your body and mind 
relax even more... nineteen... twenty. You are now in a deep and comfortable state of hypnosis. 
I would like you now to picture something in your mind. Imagine yourself standing in the middle 
of a large room, a large room with white-painted walls and a hardwood floor, imagine yourself 
standing barefoot on the wooden floor ... see it and feel it clearly in your mind, feel the hard 
wooden boards under your feet. Look at the wall in front of you in this room, there is a door 
there in the wall, see the door in front of you in the wall if you concentrate. Now I would like 
you to walk up to the door but do not open it yet. Just walk across the floor and stand in front of 
the door. Notice the door, pay close attention to it now... notice what it is made of ... and notice 
the door handle, what kind of door handle it is. In a moment, when you open the door and step 
outside, you will step out onto a beach. A beautiful, sunny beach. Now in your mind, open the 
door and step outside. Step outside. You are now on the beach. You can see it and feel it now 
clearly. See the intense beautiful blue of the sky ... and the bright yellowish white sun shining 
high above you. There is not a single cloud in the sky ... Notice the shimmering of the sunlight 
on the water. You can feel the heat of the sun on your face and on your clothes. The sand is hot 
under your feet. Feel the hot dry sand under your feet and between your toes as you walk along 
the beach. And smell the air. Notice if you can smell anything? Perhaps it is a salty smell ... 
maybe you can smell seaweed? This is a pleasant place where everything looks so relaxed and 
happy. Look around you there on the beach. Maybe there are people there in the distance, further 
down the beach, playing happily with a ball or a Frisbee. This is a carefree and relaxed place. 
And listen now, you can probably hear the sounds of the beach if you concentrate. Notice what 
the sounds are. Maybe you can hear seagulls,... or maybe you can faintly hear the laughter of 
people playing in the distance ... or perhaps you can even hear the little sounds of the water 
lapping against the shore. Now walk down to the edge of the water. Walk on the hot beach sand 
down to the water. As you come down to the edge of the water ... you can feel the sharp change 
from hot dry sand to wet, cool sand that sticks to your feet. Now step into the water just a little 
bit, until it reaches your ankles ... Feel the comfortable coolness of the clear water as tiny waves 
wash around your ankles ... Feel the refreshing coolness of the water. And see how wonderfully 
clear and beautifully blue the water is. Look out over the water ... as far as you can see. There are 
fishing boats out there in the distance ... sitting lazily on the horizon ... See the boats out there in 

 
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the distance, just sitting there out on the ocean so carefree and calm ... Now you can step out of 
the water again. You can once more feel the hot, dry sand under your feet and between your toes 
as you walk up the beach, the sand feels even hotter now because you are coming out of the cool 
water ... Walk up the beach ... There is a large beach towel lying on the sand there in front of you 
... See the towel there on the sand in front of you. Walk up to it. Walk up to the towel, sit down 
on it and just relax. Sit down on the towel. Feel the sand shaping itself beneath the towel 
conforming to the weight of your body ... and now you can just lie down on the towel and relax 
completely. Just relax your body completely ... and enjoy the carefree comfort of the warm 
beach. Allow the relaxed and healthy feeling of the beach to fill your body as you continue to 
relax. Out on the beach on a beautiful day you are far away from all your troubles and cares. So 
far away from all discomfort. You may feel inside like nothing can disturb your deep comfort, 
like nothing can upset you inside or cause you discomfort or pain, that no troubles can get to you 
and that all discomfort disappears from your life. 
After you wake up from this state in a little while, you will most likely notice that you are 
carrying that deep sense of calm and comfort with you inside of you. In the next few days, you 
may notice that bowel sensations that would have been uncomfortable before do not bother you 
any longer ... they bother you no more than the little sounds of small waves washing ashore with 
a steady rhythm like when you are relaxing perfectly comfortable on the sunny beach. Bowel 
sensations that would have been uncomfortable before do not seem to make you uncomfortable 
in the same way anymore, as you continue to become less and less sensitive to pain and 
discomfort inside your body from this moment on. You will notice more and more from day to 
day that in many situations where you might have experienced bowel discomfort or pain before, 
you only feel pleasant sensations inside. Gradually it feels more and more like nothing can upset 
your stomach or cause pain in your intestines anymore. You will probably be pleasantly 
surprised to find that your bowels are beginning to function in all situations with a healthy, quiet, 
natural rhythm that is comfortable and soothing and hardly noticeable at all, --just like the gentle 
sounds of small waves in the background on a calm and sunny day at the beach. And even if you 
feel discomfort inside, you will most likely notice more and more that it is surprisingly weak, 
much weaker than before, as your sensitivity to pain in your stomach and intestines is gradually 
and steadily fading away more and more, leaving you more comfortable and healthy every day). 
And now you can just let the whole beach scene dissolve gradually in your mind as I count 
slowly back from twenty to one. At the count of one you will open your eyes and you will be 
wide awake, in your normal state of wakefulness. You will be relaxed and refreshed and not have 
any uncomfortable or unpleasant aftereffects. Twenty ... (CONTINUE SLOW COUNT 
BACKWARDS) ... three ... now you are close to waking up ... two ... you are about to wake up 
... and one ... wake up! Wide awake. 

 
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IBS Session Three 
Make yourself comfortable in your seat. Find a position that you can maintain without effort. 
And just relax your body. Relaxed and comfortable. In a moment, I am going to ask you to look 
up at a spot in the ceiling once again, like before, and to just concentrate on it and on my words 
as I count slowly to three. 
Now please look up at the spot on the ceiling. Concentrate on the spot as you just listen to my 
words ... Relax your body. Relax your muscles and let your body become limp and heavy ... limp 
and heavy. One ... and as your body relaxes and becomes heavier, your eyelids will also begin to 
feel heavier and heavier. ... Just relax and allow this feeling of heaviness to come over you, while 
you continue to look at the spot as long as you can ... Your eyes become tired and your eyelids 
heavy as your body relaxes. Two ... now take a deep breath, a really deep breath, and hold it in ... 
hold it, and now breathe out slowly, and concentrate on the comfortable feeling of heaviness in 
your body that comes with breathing out. This heaviness also comes over your eyelids, making 
them heavier and heavier ... they are becoming so heavy, they may already be pushing down, 
pushing down, heavier and heavier with every word I say, as you just let go and relax ... let go 
and relax ... feel the heavy feeling in your eyelids that grows stronger and stronger, stronger and 
stronger. Your eyes get tired from staring and they just want to close, your eyelids just want to 
sink down under their own heavy weight ... and Three, your eyes are closing, closing as you just 
let go and relax ... heavier ... closing, as you just let go and relax. Closing by themselves, closing 
by themselves, your eyes are closing completely... 
You can just close your eyes now ... and allow yourself drift off into a comfortable state of 
hypnosis as we continue. It is so much easier to relax now that your eyes are closed. I would like 
you now to concentrate your thoughts on your hands ... and to listen closely to my words. As you 
focus your attention on your hands, you become more aware of them than you usually are. You 
can feel every little sensation in your hands as they just lie there resting on your lap ... notice 
how they feel ... notice whether they are warm or cool ... light or heavy ... are they tense or 
relaxed?... And as you pay such close attention to your hands, let all the little muscles in the 
hands relax ... feel all the muscles in your hands becoming softer and more relaxed ... softer and 
more relaxed ... feel your fingers relaxing ... and your hands becoming heavy and more and more 
relaxed ... and now let that relaxation spread up into your forearms ... relax all the muscles in 
your forearms ... the forearms heavy and relaxed, and the upper arms, too, let all the tension 
leave your arms and hands and allow them to become limp ... limp and heavy ... heavy and limp. 
Let the relaxation spread further up your arms all the way up into your shoulders. Let the 
relaxation spread deep into your shoulders, relaxing all the muscles of your shoulders. Let these 
waves of relaxation spread all through the muscles of your shoulders, replacing any tension with 
a soft and loose feeling of relaxation ... Your shoulders, soft and loose ... soft and loose and 
comfortable. Feel your shoulders becoming more and more limp and relaxed ... more and more 

 
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relaxed ... and you might also feel a warm sensation spreading in your shoulders as they relax ... 
a comfortable soothing feeling of warmth. And now let the relaxation spread down from your 
shoulders and begin to flow down your back. Wave after wave of relaxation flowing down your 
back... relaxing your upper back... and also your lower back... your whole back letting go of any 
tension and becoming more comfortable. 
And let these waves of relaxation continue to wash down your body, down into your thighs, 
loosening and softening the muscles of your thighs ... making every muscle in your thighs soft ... 
so soft and limp and loose .... comfortably relaxed ... and allow your legs to share in this limp 
and loose relaxation all the way down .... All the muscles of your legs becoming limp and loose, 
and your legs heavy ... heavy and limp, all the way down into your feet, relaxing every body part 
on the way down, making every part of your body heavier and more relaxed. Even your feet can 
share in this growing sense of loose and soft relaxation ... relax your feet more and more .... the 
right foot completely relaxed ... relax your right foot completely ... and now allow your left foot 
to also become totally relaxed. 
Your whole body gradually becomes more and more comfortably relaxed. Your entire body from 
head to toe becomes more and more relaxed as we continue.  
I am now going to count slowly from one to twenty ... and with each number in the count, you 
will find yourself going down sinking deeper and deeper into a deep, comfortable and relaxing 
hypnotic state. One, you go deeper into the hypnotic state as you relax even further. Two... 
deeper and deeper ... three...deeper down into a carefree state of comfort and ease, four... more 
and more relaxed, deeper into the hypnotic state... five... there is nothing to worry about now, not 
a care or concern in the world, six... you continue to go deeper... seven.... eight... nine... ten... 
There are no troubles to bother you right now... you are drifting far away from all the cares and 
concerns in the whole world, just drifting down, sinking safely and comfortably down into a 
carefree and comfortable state of hypnosis. Eleven... twelve... you go deeper down, deeper into a 
state in which you can most likely picture things more clearly and vividly in your mind than you 
usually can... thirteen.... sinking easily and effortlessly deeper into the hypnotic state, letting go 
more and more... fourteen.... you go still deeper... fifteen... sixteen.... seventeen... your mind 
quiets down, settles automatically into a focused and effortless state... eighteen.... deeper down, 
and your mind and body relax even more... nineteen ... relax even more... twenty. You are now in 
a deep and comfortable state of hypnotic relaxation. Just let your body relax completely. Relax 
completely. 
I would now like to ask you to once again to picture something in your mind. Picture yourself 
again in a large, white-painted room with a wood floor. Imagine yourself standing in this room ... 
see it and feel it clearly, ... see it clearly now. And look at the wall in front of you. There is a 
door there. See the door in front of you. I would like you now to walk up to the door but do not 
open it yet. Just stand in front of the door and pay close attention to this door. Notice what it is 
made of, and pay especially close attention to the door handle, what kind of door handle this is. 

 
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See this clearly in your mind. In a moment, when you open the door and walk out of the room, 
you will find yourself walking into another room. Now open the door and walk into this other 
room. See it now. You are now inside an old and spacious log cabin up in the mountains. You 
can see it clearly now. You are standing on the hard wood floor in the middle of this log cabin 
room. It is dimly lit, it is evening and the only light is the warm light from the fire burning in the 
fireplace to your right. Look at the fireplace and see the fire burning brightly yellow and red. It is 
comfortably warm in this cabin. The air smells a little bit of wood smoke. It is a strong smell but 
not uncomfortable. Look at the walls around you. See the big, strong logs that the cabin is made 
of. They are so thick and heavy and strong that it seems that nothing could affect them. No 
matter what happens outside, no matter how strong the winter storms are, the mountain cabin is a 
safe and comfortable place. You can walk over the wall nearest to you and touch the log wall. 
Touch the wall now. You can touch the wall now. Notice how rough and hard the logs feel. They 
are almost as hard as rock. And feel the smoother material between the logs -- the material that 
provides insulation. Notice also, as you touch the wall, whether the wall feels warm or cool to 
the touch ... And see also how the shadows play on the wall in the light from the fire. Look at the 
shadows playing on the wall ... and listen now. You can probably hear the crackling sound from 
the fireplace. It is a soothing sound, a sound that means warmth and rest and comfort ... There is 
a little window there a little further along the wall. Now walk over to it. And as you walk over 
there, you can perhaps hear the creaking sounds of the wood floor under your feet. The floor is 
strong and solid, these are just the sounds that old wood floors make. Now you can see the little 
window in front of you. It is dark outside, but you can see the delicate lace pattern that the frost 
has made on the window. Reach out with your hand and touch the windowpane. It is so smooth 
and so ice-cold. And feel how it is wet as your fingers melt the thin film of ice on the window. 
And while you are so close to the window you can perhaps hear the faint high-pitched howling in 
the winter storm outside. It is so nice to be inside when it is so cold and so windy outside. Now 
turn around and look around you in this room. Over to the side, closer to the fireplace, there is 
large and comfortable-looking bed in the corner. See the big bed there in the corner? You can see 
it clearly now if you concentrate. Notice in particular the comforter on the bed. Notice the color 
and the old-fashioned pattern. Now walk over to this comfortable-looking bed. Walk up to the 
bed and stand in front of it. And as you do, you can probably feel the warmth from the fire on 
your face -- because you are closer to the fireplace now. And you can just lie down on this 
comfortable bed now. Just lie down on this wonderfully soft bed and relax. Relax completely 
there in the warmth and comfort of the log cabin, far up in the mountains, far away from all cares 
and concerns. Relax your whole body completely. Relax completely. Relaxing inside a warm, 
safe comfortable mountain cabin like this, nothing can disturb your comfort. The thick walls 
protect you from all discomfort. Even though the storm is howling outside, you can barely notice 
it in the safe comfort of the log cabin. 
In the same way, you are protected more and more every day from pain and discomfort in your 
stomach and bowels. You are becoming less and less sensitive to discomfort or pain until nothing 

 
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can upset or irritate your intestines anymore. More and more it feels like your intestines are 
protected from all discomfort, like nothing can upset them, just like you are protected from the 
winter storms when you are resting inside the mountain cabin. No matter how strong they blow 
outside the thick protective walls that keep you warm, comfortable and safe, you can feel 
comfortable and relaxed inside. Perfectly comfortable and relaxed inside. You may find more 
and more that you hardly notice the sensations that before would have caused you pain or 
discomfort in your intestines. Sensations that used to be uncomfortable now increasingly feel just 
mild and soothing and do not bother you anymore. 
And even if you feel discomfort inside, you will most likely notice that it is surprisingly weak, 
much milder than before, as your sensitivity to pain in your stomach and intestines is gradually 
and steadily fading away more and more, leaving you more comfortable and healthy every day. 
Your sensitivity to pain is decreasing steadily from one day to the next, and one week to the next, 
allowing you to enjoy your everyday life more and more without being disturbed or bothered. 
You pay less and less attention to unpleasant feelings inside you every day, as your sensitivity to 
bowel pain and discomfort steadily fades away and disappears. 
In a moment, I am going to start counting slowly backward from twenty to one. For most of the 
count you will still be in the deeply relaxed state that you are in now, but at the count of one, you 
will be fully awake, in your normal state of wakefulness. You will feel relaxed and refreshed 
when you wake up and you will not have any unpleasant or uncomfortable aftereffects. Twenty... 
<CONTINUE SLOW COUNT BACKWARD>... three... now you are close to waking up... 
two... you are about to wake up, your eyes are opening, one... Wide awake. 
IBS Session Four 
Please make yourself comfortable in your chair. Find a comfortable position so that you can be at 
ease without having to move around. Good. Let your body begin to relax, and like before, find a 
spot in the ceiling -- one spot to look at. Simply concentrate on the spot and as you listen to my 
words, and continue to relax your body ... Relax your body. I will now begin the count from one 
to three, and with each number your eyelids will most likely become heavier and heavier until 
they close. Listen to my words and keep looking at the spot. But as I count, just allow the 
heaviness to come into your eyelids, and when they feel like closing, just allow it to happen. One 
- relax your body, relax your muscles, allow your body to become heavy and limp, heavy and 
limp ... and as you do that, your eyelids also become heavier and heavier, heavier and heavier, 
and soon they will start pushing down, pushing down with more and more force as the heaviness 
in your eyelids grows and grows. Let your body become more and more relaxed and limp and 
heavy. Relaxed and limp and heavy. Simply allow this to begin to happen to you in an automatic 
way. You do not have to help it along, and there is no need to resist it, either, all you have to do 
is to let go - let go and allow your body to become limp like a rag doll, heavy and limp and 
relaxed. And as this happens, as the comfortable feeling of limp heaviness begins to grow 

 
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stronger into your body, notice that your eyelids also feel more heavy, more and more heavy, 
until they close all by themselves, all by themselves. Two - Now take a deep breath, a very deep 
breath, inhale....and hold your breath ... hold it ... and exhale very slowly, and as you do so, relax 
your body even more. Feel the tension leave your body as you breathe out... making it even more 
relaxed and heavy. Your eyelids also become still heavier, still heavier, and the eyes become 
more and more tired, more and more tired with every word I say. It would be so nice just to close 
your eyes and allow yourself to drift into the pleasant state of hypnosis. Feel the heaviness in 
your eyelids growing more and more, as if they are weighted and the weights are becoming 
heavier and heavier, forcing the eyelids down. Down, down, Three your eyelids close all by 
themselves, all by themselves. Closing... closing, heavier and heavier. Closing completely, 
closing completely. 
Now you can just close your eyes completely... close your eyes completely and allow yourself to 
let go and drift into a relaxed hypnotic state. That's good. You are able to relax even more deeply 
now that your eyes are closed. Now I would like you to concentrate your thoughts on your hands 
and listen to my words. As you focus your attention on your hands ... you can feel them more ... 
You may even be able to see your hands in your mind's eye ... and while you are paying close 
attention to the hands ... so aware of every sensation and feeling in them ... let the hands relax 
even further ... let all the muscles in the hands relax just by thinking about them relaxing ... 
beginning in the fingers ... feel how all the muscles in your fingers becoming smoother and softer 
and more relaxed ... more and more loose and relaxed ... as you think about them relaxing ... 
more and more relaxed ... allow this limp feeling of relaxation to take over in your fingers... your 
fingers relax more and more... and now, let the relaxation spread up into your hands .... feel the 
hands grow heavier and heavier as the tension disappears and they become limp and comfortably 
relaxed ... it may feel, as we continue, almost like you are turning off switches in your nervous 
system, making each body part completely heavy and inactive, comfortably heavy and loose and 
relaxed, as you concentrate on that part. Now relax the muscles in your forearms ... relax every 
muscle in your forearms ... just turn the tension and activity in them off-in-your-mind, relax them 
completely, they are not needed at all right now ... they can let go and rest ... and relax the upper 
arms, too, let all the tension leave your arms and hands completely, allow them to be limp ... 
completely limp and loose ... your arms and hands limp and loose and heavy. Allow the arms to 
just hang down from your shoulders, and let your hands just lie there still and heavy. It may feel 
almost like your arms and hands are made of heavy rubber, lying there limp and comfortably 
relaxed. 
Now turn your attention to your shoulders ... let the comfortable relaxation begin to spread into 
your shoulders, transforming the muscles in your shoulders into a soft and relaxed mass ... feel 
the muscles in your shoulders becoming soft and smooth, so soft and loose, as the relaxation 
spreads all over the shoulder muscles from the arms ... relax your shoulders more and more ... 
relieving you of any tension and stiffness. Your shoulders settle down into this soft state of 

 
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comfort. Soft and loose and comfortable. And feel this relaxation flow down your body ... 
flowing down into your chest ... relax the muscles of your chest ... as the tension in your chest 
evaporates, you can breathe more easily ... freely and deeply... Relax the muscles in your back ... 
let your whole back share in this feeling of soft comfort taking over ... Your whole back more at 
ease ... loose and relaxed. Allow the relaxation to flow on down your body ... down into your 
thighs ... the muscles of your thighs become soft and loose, and let the relaxation spread on down 
your legs ... your legs become heavy ... heavy and limp ... heavy and limp .... All the muscles in 
your legs becoming soft and loose, making the legs feel heavier and heavier ... and allow your 
feet to relax, also ... relax your feet more and more ... your right foot completely relaxed ... every 
muscle soft and loose ... relax your right foot completely ... and now allow your left foot to also 
become totally relaxed ... soft and loose and relaxed. 
Your whole body becomes comfortably relaxed. Your whole body continues to become more 
and more relaxed, comfortably warm and heavy and relaxed, your body continues to become 
even more relaxed all over as we continue ... 
Now I would like you to imagine something and see it clearly in your mind. Picture an open 
elevator in your mind, imagine yourself standing in front of an open elevator door. As you stand 
there, you can see the inside of the elevator. This is a large and luxurious elevator. See the 
beautiful wood- paneled walls. This is an elevator like they have in the most expensive and 
luxurious hotels. There is a comfortable-looking padded bench in the elevator. A bench to sit on. 
In your mind, go inside the elevator and sit down on the bench. Go inside and sit down on the 
bench. If you look around you, as you sit there in this luxurious elevator you can see the light 
panel on the wall with the numbers from one to twenty. Notice that the number one is lit up at 
the moment. I am now going to begin to count slowly from one to twenty in a moment. 
Concentrate your attention on the number panel. I will count slowly from one to twenty in a 
moment, and with each number in the count from two to twenty the corresponding number will 
light up on the elevator wall panel and you will find yourself going down, down deeper and 
deeper, automatically and effortlessly, going down into a deep and comfortable and relaxing 
hypnotic state. Not everybody pictures things as clearly in their mind, and even if you do not see 
this very clearly, that is all right. You will still go deeper and deeper with every number in the 
count. But most likely, you can see the light panel in front of you now. Notice the color, what it 
is made of, and so on. Concentrate on this. One... the elevator door is closing, it closes and you 
are now ready to sink safely and comfortably down into a deep hypnotic sleep. . . two, you can 
feel yourself beginning to move gently down in the elevator, down deeper into the hypnotic state 
as you relax more and more... your body relaxes even more... and will become even more relaxed 
with every number in the count... three ... see the lights changing on the elevator light board ... 
lighting up one number after another as you go down, sink gently deeper and deeper down into 
the hypnotic state... four... five... you go deeper into the hypnotic state with each number and 
relax more and more in an automatic way... six... see the numbered lights changing as you go 

 
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deeper down... deeper with each number... seven... eight... and as you sink gently and safely 
down, deep down with each number, you probably find that your mind calms down more and 
more, as your mind withdraws from all the cares and all the concerns in the world ... letting go of 
all worries and concerns... nine... nothing matters right now except just enjoying letting go... 
enjoying relaxing... ten... there are no troubles to bother you now... you can just permit yourself 
to let all worries and cares fade away, far away... as you sink slowly deeper... drifting down, 
sinking safely and comfortably down into a carefree and comfortable state of hypnosis... eleven... 
twelve... going down into a focused state in which you can probably let visual images come into 
your mind effortlessly in vivid detail... thirteen... fourteen... you go still deeper... fifteen... 
sinking down comfortably into a deeper state of hypnotic relaxation... sixteen... when the 
elevator is all the way to the bottom at the end of the count, the elevator door will open, and you 
will find yourself walking out of the elevator and stepping straight out into a secluded and 
beautiful garden... seventeen... deeper and deeper... eighteen... and your body and mind relax 
even more... your body and mind relax even more... nineteen.... twenty.  
You are now in a deep and comfortable state of hypnosis. Look at the elevator door now, picture 
the elevator door opening in front of you. Outside is a wonderful garden, you can see a beautiful 
sunny garden with lush plants. Step out into the garden. If you turn your head in your mind and 
look back at the elevator, you can still see the open elevator door there set in an old brick wall. 
The wall is tall and strong, and there is moss growing on the old bricks. Walk up to the wall 
beside the elevator and touch the wall. The wall is warm in the sunshine. Feel the roughness of 
the old bricks and how this contrasts with the feel of the very soft and cool and slightly moist 
moss growing between the bricks. Feel it. The moss is so soft, and cool and velvety, and the 
bricks so hard and rough. You can turn around now and enjoy the relaxed comfort of nature in 
bloom in this quiet and secluded garden. The air smells so fresh and wonderful in this garden, 
blended with the fragrance of exotic flowers. Smell the fresh and fragrant air... And look in front 
of you. There is a path in front of you, made of smooth, gray stone slabs that curves across the 
soft green grass of the lawn, weaving between the trees and bushes. See the path there in front of 
you. Now walk down the path; you can feel the hard and smooth stone slabs under your feet. As 
you walk lazily down the path between the bushes and trees, you can see a variety of colorful 
plants on both sides... red, white, blue, and yellow plants. The colors are so bright and vivid, set 
against the bright green of the grass, and the slightly darker green leaves of the bushes. If you 
stop for a moment there on the path, you can perhaps reach out and touch the leaves of the bush 
there right next to you to your left. Reach out in your mind with your hand and touch the leaves. 
Feel the leaves. Feel how the leaves have a slightly rubbery texture, and how they are smoother 
on the upper surface and rougher on the underside ... Now you can just let go of the leaves again, 
and continue down the path. Continue on, wandering further down the path. You may not have 
noticed it, but now when you pay attention to it, you can feel the warmth of the sun on your face. 
Feel how comfortably warm your face is from the rays of the sun high in the sky. And notice 
how, as you walk on further along the path, your face is sometimes a little cooler for a moment 

 
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as you walk into the shadow of one of the large trees. As you continue on the curving path 
weaving through the garden, listen to the cheerful and carefree natural sounds of the garden. You 
can probably hear birds singing, and you may even hear the sounds of squirrels scurrying in the 
trees. Everything is so carefree and easy in this garden, it seems like nothing can disturb the 
natural beauty and harmony in this secluded place. 
Allow the tranquility and healthy comfort of the garden to fill your mind and your body ... Out 
there in this garden on a beautiful and pleasantly warm day, you are so far away from all your 
troubles and cares. So far away from all discomfort.... It may feel like you are completely 
wrapped in deep, warm, relaxing comfort ... Let your body soak up that feeling of warm and 
healthy comfort - almost like you are soaking up with your body the peaceful and undisturbed 
feeling of this beautiful secluded garden. Feel a warm sensation deep inside your stomach ... 
Focus your mind on this comfortable and soothing, warm feeling in your stomach ... and allow 
that feeling to spread deep inside your body, allow it to spread down all through your intestines 
... Let the warm comfort spread inside you, soothing your intestines and giving them a healthy, 
undisturbed feeling ... In this state of warm and relaxing comfort inside you, it probably feels like 
nothing can disturb your body. It may feel as if you are like the peaceful secluded garden inside 
your body, so far removed from all discomfort and upset that no troubles, no discomfort can get 
to you. This comfortable sense of deep peace, which you can allow to remain with you, can keep 
any discomfort that you may face outside from affecting you inside your body. You can keep this 
deep feeling of warm and healthy comfort in your stomach and intestines from day to day. It will 
be with you even when you do not pay any attention to it, making sure that you are always 
continuing to become less and less sensitive to pain and discomfort inside your body. In 
situations where you might have experienced bowel discomfort or pain before, you will probably 
be surprised to realize that you only feel pleasant warm, soothing sensations. Gradually it will 
begin to feel more and more like nothing can upset or irritate your intestines anymore. As you 
carry this peaceful warm feeling with you deep inside your body, you become more comfortable 
and healthy every day. More comfortable and healthy every day, undisturbed and peaceful inside 
like this beautiful secluded garden. 
Now continue walking through the garden, down the path, between the trees and the bushes, 
enjoying the colorful plants... <LONGER PAUSE>... As you go on further, and come around a 
bend in the path, you can suddenly see the brick wall and the open elevator there further up the 
path in front of you again. You have gone a whole circle on the path, the path weaves through 
the garden in a big circle. Just stand there for a moment on the path, relax and absorb the 
tranquility of this beautiful garden. In a moment, when you step into the elevator again, and I 
begin to count back from twenty to one, you can carry this peaceful feeling of relaxation with 
you.... allowing the body to keep that comfortable healthy feeling even after you are fully awake. 

 
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I am now going to start counting backwards from twenty to one. At the count of one you will be 
fully awake in your normal state of wakefulness. You will feel relaxed and refreshed and you 
will not have any uncomfortable or unpleasant aftereffects. 
See the elevator once again in front of you... and walk up to the open elevator door. Step inside 
the elevator and sit down on the bench. You can see the elevator door closing now. Twenty... 
Now the elevator starts moving, beginning to carry you back to the waking state. At the count of 
one you will be awake. Nineteen... <CONTINUE SLOW COUNT BACKWARD>... three... now 
you are closer to waking up... two... now you are about to wake up... one now you wake up and 
open your eyes. Wide awake. 
IBS Session Five 
Please make yourself as comfortable as you can in your chair, finding a position that you can 
keep comfortably with minimum effort. Good. Look up at the spot in the ceiling and let your 
body begin to relax. Just concentrate on the spot and listen to my words, and at the same time 
relax your body. I will now begin the count once again from one to three, like always before, and 
with each number your eyelids will probably become heavier and heavier until they close. All 
you have to do is to listen to my words, relax your body and keep looking at the spot. One ... 
relax your body, allow it to become heavy and limp, heavy and limp, ... your muscles all over 
your body becoming soft and loose, and as you relax, your eyelids also begin to feel heavier and 
heavier, heavier and heavier, and soon they will start pushing down, pushing down with more 
and more force as the heaviness in your eyelids grows and grows. Let your body become more 
and more relaxed and limp and heavy. Relaxed and limp and heavy. Simply allow this to begin 
to happen to you in an automatic way, all by itself. Just let go, let go and allow your body to 
become limp like a rag doll, heavy and limp and relaxed. And as this happens, your eyelids will 
feel more and more heavy until they close all by themselves, all by themselves and you will drift 
comfortably into a deep hypnotic state. Two Now take a deep breath, a very deep breath, inhale 
... and hold ... hold your breath ... and exhale very slowly, and as you do, feel the tension leave 
the body so it becomes even more relaxed ... even more relaxed and heavy. Your eyes become 
more and more tired and your eyelids become heavier, still heavier. Feel the heaviness in your 
eyelids growing more and more, as if they are weighted and the weights are becoming heavier 
and heavier, forcing the eyelids down. Down, down, Three, your eyelids close all by themselves, 
all by themselves. Closing ... closing, heavier and heavier. Your eyes are closing completely, 
closing completely now. 
 
 Even if your eyes have not closed completely yet, that is all right. It does not matter. And 
there is no need to strain your eyes more. You can just close your eyes now ... close your eyes 
and allow yourself to let go and drift into a relaxed hypnotic state. Let yourself sink into a 
comfortable and restful state of hypnosis. 

 
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 Now I would like to ask you to focus your attention on your hands and listen to my 
words. Focus your whole attention on your hands so that you become more aware of them than 
you ordinarily are... and while you are paying such close attention to the hands... allow all the 
muscles in your hands to relax... beginning in the fingers... feel all the muscles in your fingers 
becoming softer and more relaxed... more and more relaxed... more and more relaxed... you may 
begin to feel a little tingling sensation in your fingers as they relax,... or feel that they are 
becoming warmer... pay close attention to this feeling of relaxation. And now, let the relaxation 
spread up into your hands... feel the hands becoming heavier and heavier... the muscles in the 
back of your hands, and in your palms, become soft and loose as the tension just fades away... 
and your hands become heavy and limp, more and more heavy and limp. Totally relaxed. And 
now, let that relaxation spread up your arms, through your wrists and up to your elbows. You can 
feel the tension leaving your arms. Feel the comfortable heaviness increase more and more in 
your arms. The muscles in each body part become completely heavy and inactive as you 
concentrate on that part. Let the relaxation spread on further up your arms, all the way up to your 
shoulders. All the muscles in your arms become heavy and limp, limp and loose. Your arms, 
limp and loose ... limp and heavy. Allow the arms to just hang down from your shoulders, and let 
your hands just lie there still and heavy. 
 
 Now turn your attention to your shoulders... let the comfortable relaxation spread into 
your shoulders, transforming the muscles in your shoulders into a soft and smooth mass ... feel 
the muscles in your shoulders becoming so soft and loose as the relaxation spreads into them 
from the arms... relax your shoulders more and more... and feel this relaxation spread down your 
body... relaxing your chest... feel the muscles in your chest relaxing, removing all tension, so you 
can breathe freely and deeply, ... freely ... and slowly ... and deeply. Relax all the muscles in your 
back ... relax your stomach ... allow the relaxation to spread further down your body, spreading 
down your body, relaxing each part of your body ... let the relaxation spread all the way down 
into your legs... your legs become heavy and limp... heavy and limp... feel the muscles become 
softer and more relaxed... in your thighs... and in your knees and in your calves... and allow the 
relaxation to reach all the way down into your feet... relax your feet more and more... relax your 
right foot... your right foot completely relaxed... relax your right foot completely... and now 
allow your left foot to also become totally relaxed. You are becoming very deeply and 
comfortably relaxed, and you will become even more relaxed as you continue to listen to my 
words. Your whole body becomes more and more relaxed. Your body may begin to feel a little 
numb, and that is fine. You do not really need to pay close attention to the feelings in your body. 
You can just let go of paying attention to it, and let it relax more and more in an automatic way 
just as you let go of everything else in this comfortable and restful state. 
You can become even more relaxed than you are now. I am now going to count slowly from one 
to twenty. With each number in the count, you will find yourself going down deeper and deeper 
into an even deeper and more comfortable and relaxing hypnotic state. Your mind will especially 

 
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calm down more and more. As I count, you can just allow yourself to drift away from all your 
everyday cares and just enjoy this carefree and comfortable state you are in. You can perhaps 
imagine yourself sinking gently down, deeper and deeper with each number and drifting far 
away from all the cares in the world, until everything you usually worry about disappears totally 
from your mind. One... you sink down, deeper into the hypnotic state as you relax more and 
more... two... deeper and deeper... three... four... five... deeper into the hypnotic state... there is 
nothing to worry about now, not a care or concern in the world... six... you go on still deeper... 
just allow yourself to turn within, away from you everyday worries, all you have to do is to listen 
to my voice and enjoy the relaxation... nothing else matters now... seven... eight... nine... ten... 
you are drifting far away from all the worries and concerns in the world ... drifting down, sinking 
safely and comfortably down into a carefree and comfortable state of hypnosis, eleven ... twelve 
... thirteen ... fourteen ... you go still deeper ... fifteen .... sixteen ... seventeen ... deeper and 
deeper ... eighteen ... and your body and mind relax even more ... nineteen ... twenty. You are 
now in a deep and comfortable state of hypnosis. 
I would like to ask you now to picture something in your mind. Imagine yourself standing 
outside, on a grassy hill out in the open country. Just imagine yourself standing there, picture it 
clearly, as if you had just opened your eyes and found yourself there. The grass around you is tall 
and yellowish green. It reaches up to your knees. If you look around you, you can see low, 
rolling hills in all directions, covered with the same yellowish grass. Further in the distance, you 
can see bluish mountains. These are magnificent and majestic mountains. There is a slight breeze 
blowing, you can feel the breeze on your face. It is refreshing, this feeling of clean and fresh air 
on your face, and you can see the gentle breeze moving the grass around you in a wave-like 
motion. Look at the sky. The sky is such a bright color of blue, with only a few small puffy 
clouds. And notice how quiet everything is, as you stand there on the hill. There is no sound at 
all, except the quiet whisper of the wind in the grass ... If you look down the hill to your right, 
you can see a pond down there, below the hill, not far away. And look closely, see this clearly 
now, there is a small boat down there by the bank of the pond. From where you are standing 
now, it seems to be just the right size for one person. Start walking down the hill. Walk down the 
side of the hill toward the pond. And as you do that, hear the swishing sound that is made when 
your legs move through the tall grass, and the little cracking sounds that come when you step 
down and break the straws. Walk all the way down the side of the hill and down to the boat that 
is rocking there gently by the side of the pond. This is a beautiful pond. The water reflects the 
intense blue color of the sky. Look at the boat. It is indeed a boat made for one person. It has a 
very comfortable-looking seat in the middle with a large cushion on it. There is also a pair of 
oars there lying in the bottom of the boat. The boat is so close to the bank that you can easily step 
into it. Step into the boat, it is perfectly safe. Step into the boat, and sit down in it. Feel the 
comfort of the thick and soft cushion under your body. And notice the slight rocking of the boat, 
it is almost imperceptible, because the surface of the pond is so calm, but you can feel it if you 
pay close attention. Now reach out in your mind with your hand and push the boat gently away 

 
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from the bank. As you do, feel the wetness and coolness of the mossy bank. As you drift away 
from the bank, you can feel the boat rocking a little bit more for a minute and you can hear tiny 
waves lapping against the bow, but then it calms down, and as it does you also calm down even 
more and just relax completely, sitting comfortably in a boat far out in nature, drifting 
comfortably and safely on a calm and beautiful pond, far removed away from all your concerns 
and everyday worries. Your body is totally relaxed and your mind is completely calm.  
Allow the relaxed and healthy feeling of unspoiled nature all around you to fill you as you 
continue to relax. Out there, so far away from all your troubles and cares, you can let your body 
relax completely. You can let the soothing tiny rocking motion relax you more deeply inside also 
- allow it to soothe your stomach and intestines, making them comfortably relaxed - enjoy this 
profound relaxation... resting out there surrounded by beautiful undisturbed nature, hundreds of 
miles from all problems... So far away from all disturbance and discomfort that it probably feels 
like nothing at all can get to you and that all discomfort is hundreds of miles away. Your 
intestines can keep this healthy and comfortable feeling even after you wake up in a little while 
and go about your business: Your intestines can continue to stay calm and comfortable, far 
removed from all discomfort and immune to all pain ... as distant from any discomfort and 
disturbance as you feel when you are far away out in nature: Healthy and undisturbed. After you 
wake up from this state in a little while, it will probably feel more and more like no troubles can 
get to you inside, and that all discomfort is disappearing from your life more and more, day by 
day. Bowel sensations that would have been painful before are no longer uncomfortable at all, 
you will hardly notice them, and they will not bother you any more than you are bothered by the 
gentle soothing rocking motion of the boat when you are floating on this beautiful still pond. 
In a moment, I am going to start counting backward from twenty to one. For most of the count 
you will be in the deeply relaxed state you are in now. As I begin to count down, you can just let 
the feeling of being in the boat gradually dissolve from your mind, and when I get down to one 
in the count, you will be wide awake with your eyes open, in your normal state of wakefulness. 
You will feel relaxed and refreshed, and you will not have any negative or uncomfortable 
aftereffects. Twenty... <CONTINUE SLOW COUNT BACKWARD>... three... you are now 
close to waking up... two... you are now almost awake... one now you wake up and open your 
eyes. Wide awake. 
IBS Session Six 
Please make yourself as comfortable as you can in your chair. Just find an easy position to relax 
in, a position that you can keep without having to move around too much. Good. Let your body 
relax, and look up at the spot in the ceiling. Just concentrate on the spot and listen to my words, 
and at the same time relax your body. I will now begin the count once again from one to three, 
and as I do that, a heavy feeling will probably come into your eyelids, and the eyelids will 
become heavier and heavier with each number until they sink down and you close your eyes. 

 
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When you feel the heavy feeling coming into your eyelids, - when your eyes feel like they are 
ready to close - you can just allow it to happen. One ... relax your body, allow it to become heavy 
and limp, heavy and limp, ... and as you do, your eyelids also begin to feel heavier and heavier, 
heavier and heavier, and soon they will start pushing down, pushing down more and more as the 
heaviness in your eyelids grows more and more. Let your body become more and more relaxed 
and limp and heavy ... Relaxed and limp and heavy. Simply allow this to begin to happen to you 
in an automatic way, all by itself. Just let go ... let go, and allow your body to become limp like a 
rag doll, heavy and limp and relaxed. And as this happens, your eyelids will gradually feel more 
and more heavy until they close all by themselves, all by themselves, and you will drift 
comfortably into a deep hypnotic state. Two. Now take a deep breath, a very deep breath, inhale 
... and hold your breath ... hold it... and exhale very slowly, and as you do, feel the tension leave 
your body so it becomes even more relaxed ... even more relaxed and heavy. Your eyes become 
more and more tired and your eyelids become heavier, still heavier. Feel the heaviness in your 
eyelids growing more and more, as if they are weighted and the weights are becoming heavier 
and heavier, forcing the eyelids down. Down, down ... Three ... your eyelids close all by 
themselves, all by themselves. Closing ... closing, heavier and heavier ... heavier and heavier. 
Your eyes are closing completely, closing completely now... 
You can just close your eyes completely now ... let your eyes be completely closed and allow 
yourself to let go. Just let go and drift into a relaxed hypnotic state. Let yourself sink ... sink into 
a comfortable and restful state of hypnosis ... 
Now please focus your attention on your hands and listen to my words. Pay attention to your 
hands so that you become more aware of them than you usually are ... and while you are paying 
such close attention to the hands ... allow all the muscles in your hands to relax ... beginning in 
the fingers ... feel all the muscles in your fingers becoming softer ... softer and more relaxed ... 
more and more relaxed... more and more relaxed ... you may begin to feel a little bit of a tingling 
sensation in your fingers as they relax ... or you may feel that they are becoming warmer ... pay 
close attention to this feeling of relaxation. And now, let the relaxation spread up into your hands 
... feel the hands becoming heavier and heavier ... the muscles in the back of your hands, and in 
your palms, become soft and heavy ... soft and relaxed ... as the tension just fades away and your 
hands become heavy and limp, more and more heavy and limp. Totally relaxed. And now, let 
this relaxation spread up your arms, ... let it spread up through your wrists and up to your elbows. 
You can feel the tension leaving your arms. Feel the comfortable heaviness increase more and 
more in your arms ... your arms are becoming heavier and heavier. The muscles in each body 
part become completely heavy and inactive as you concentrate on that part. Let the relaxation 
spread on further up your arms, all the way up to your shoulders. All the muscles in your arms 
become heavy and limp, limp and loose ... limp ... and heavy. Allow the arms to just hang down 
from your shoulders, and your hands to just lie there still and heavy ... Now let the relaxation 
spread from your arms deep into your shoulders, waves of relaxation flowing into the shoulders 

 
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... easing up any tension in your shoulders and making them soft and loose... feel the muscles in 
your shoulders becoming so soft and loose ... soft and loose ... as the relaxation spreads into them 
from the arms ... relax your shoulders more and more ... your right shoulder, feel the right 
shoulder relaxing even more ... relaxing even more ... and your left shoulder ... your left shoulder 
relaxes too ... and feel this relaxation spread down your body ... relaxing all the muscles in your 
chest ... feel the muscles in your chest relaxing , all the tension fades away from the muscles of 
your chest, so you can breathe freely and deeply, ... freely ... and deeply. And as we continue, 
your body will continue to relax even more every time you breathe out. It will probably feel like 
you are drawing the tension from your body into the lungs each time you breathe in, and when 
you exhale you breathe the tension out of your body, so you become more and more relaxed. 
Relax all the muscles in your back ... feel all the muscles in your back becoming soft and relaxed 
... your whole back more and more at ease ... letting go of any tension ... and allow the relaxation 
to spread further down your body ... spreading down your body, relaxing each part of your body 
all the way down ... let the relaxation spread all the way down into your thighs and legs ... your 
legs become limp and heavy ... limp and heavy ... feel the muscles become softer ... soft and 
loose ... the muscles of your thighs limp and loose and more relaxed ... in your knees and in your 
calves ... and allow the relaxation to reach all the way down into your ankles ... your legs become 
limp and heavy all the way down into your ankles. And let the relaxation spread down even 
further, reaching all the way out into your feet ... relax your feet more and more ... relax your 
right foot... your right foot to be completely relaxed... relax your right foot completely... and now 
allow your left foot to also become totally relaxed. Your left foot also limp and relaxed. You are 
becoming very deeply and comfortably relaxed, and you will become even more relaxed as you 
continue to listen easily to my words. Your whole body becomes more and more relaxed. Your 
body may begin to feel a little numb, and that is fine. You do not really need to pay close 
attention to your body now. You can just let go of paying attention to your body, and just let it 
relax more and more in an automatic way just as you let go of everything else in this comfortable 
and restful state. 
I would like to ask you now to imagine yourself now, sitting or lying on a wonderful, fluffy 
cloud ... a soft and bouncy cloud that is so soft that you can just barely feel it even though it 
carries you securely. Imagine this now, imagine and feel yourself sitting or lying on this soft 
cloud. It is almost a sensation like floating. Perhaps you can feel that floating sensation in your 
body as you enjoy the comfort of relaxing completely and comfortably on this cloud. I am now 
going to count slowly from one to twenty. With each number in the count, you will feel yourself 
sinking gently down on the cloud, down into a safe and comfortable and carefree place deep in 
your mind. You will find yourself at the same time going down deeper into a more comfortable 
and relaxing hypnotic state in a totally automatic way... One, feel yourself sinking down, ever so 
gently down, on the soft and comfortable cloud, you can probably feel it moving down, carrying 
you down into a deeper state of carefree comfort if you pay close attention. Your mind will calm 
down more and more as I continue the count, automatically, until you reach a state where you are 

 
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free from all worries and concern. A deep, carefree state of total physical relaxation and 
complete mental calm. Two. And during the count, you can just let your mind withdraw and turn 
inside. You can just allow yourself to take a break from all worries and concerns. None of it 
matters right now. Three, there is nothing to achieve or accomplish now... all you have to do is to 
enjoy this deepening state of relaxation that you feel coming over you more and more, and allow 
yourself to go even deeper as you listen to my words... you sink down, deeper into the hypnotic 
state as you relax more and more... four... more and more relaxed... five... you feel yourself 
sinking down with each number into a comfortable and safe inner space... you may notice how it 
gets just a little bit darker with each number as you let the fluffy, bouncy cloud carry you down 
into a safe and carefree inner space within your mind and deeper into the hypnotic state ... but 
this is a comforting darkness that envelopes you and makes you feel more and more safe and 
carefree and comfortable... six... just allow yourself to turn within and enjoy the drowsy and cozy 
relaxation and mental calmness that you feel coming over you more and more with each 
number... seven.... feel the cloud carrying you down deeper ... eight … you may feel the cloud 
rocking you very gently and in a soothing way as it carries you down ... nine, and you may also 
feel how the cloud begins to turn slowly around as you go deeper ... spinning very slowly as it 
sinks down almost like a feather or a leaf falling very slowly through the air... rocking gently... 
spinning slowly ... as the cloud carries you safely into an even more profound state of hypnosis 
and relaxation... ten ... you are drifting down... drifting down, sinking safely and comfortably 
down into a carefree and comfortable state of hypnosis, eleven... twelve... thirteen... fourteen... 
you go still deeper... fifteen... sixteen ... seventeen... deeper and deeper ... eighteen... and your 
body and mind relax completely... relax completely... nineteen... twenty. You are now in a deep 
and comfortable state of hypnotic relaxation. Just continue to enjoy the relaxation. Just continue 
to relax more and more. 
And as you continue to relax like that, allow yourself to slowly drift away from the here and 
now. Let yourself be carried away in your mind to a place of peace and serenity. Let your mind 
drift effortlessly toward this beautiful natural place of peace and comfort. And you can see it 
taking shape in your mind now. You are standing in a small forest clearing on a grassy bank by a 
beautiful pond, on a wonderful sunny day. You are far out in nature, far away from everything 
and everybody. You are standing barefoot on the soft grassy bank. The grass feels a little ticklish 
against your feet, but in a comfortable way. The temperature is just right to be perfectly 
comfortable. You can see the sunlight shimmering brightly on the surface of the still pond ... and 
in the background you can hear the cheerful and relaxed sound of water running into the pond in 
a small waterfall, there to your right. Lie down in the soft grass on your back, on the bank of the 
pond, and look up into the bright blue sky. You can see small puffy clouds drifting slowly 
overhead, and below them, but still far up in the sky, you can see a bird, a falcon or an eagle, 
soaring high in the sky above you. For a moment, perhaps you can follow this graceful bird with 
your eyes ... as it soars effortlessly ... floating on the gentle breeze high above you, circling lazily 
... until it drifts out of sight ... As you lie there comfortably in the grass on the soft bank of the 

 
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pond, looking up into the sky, and you let your whole body rest comfortably, notice what you 
can feel and experience ... If you listen closely, perhaps you can hear the soft rustling sound of 
the breeze moving the leaves of the treetops ... and the sounds of birds in the trees against the 
backdrop of the babbling sound of the small waterfall.... And as you lie there on your back, you 
may be able to see the tops of the tallest of-the-trees in the corner of your eye, swaying gently. 
And perhaps you can smell the fresh and fragrant air - notice the healthy and comforting scent of 
nature in bloom. Just lie there for a while, and breathe in this healthy and comforting freshness. 
Let the healthy air fill your lungs as you inhale, and when you exhale, that healthy feeling can be 
carried throughout your body, even going deep down into your intestines, filling you with 
healthy comfort inside ... restoring your intestines more and more to a natural and relaxed state 
of health more and more ... breath after breath. Let your whole body continue to soak up this 
feeling of soothing natural comfort, more and more relaxed, more perfectly comfortable inside. I 
am now going to be silent for a minute. Just let yourself enjoy this soothing and relaxing feeling 
of comfortable relaxation spreading inside you, making your feel more and more healthy, until I 
begin to talk to you again. Let the deep relaxation continue to fill you inside until I start talking 
again in a couple of minutes <SILENCE FOR TWO MINUTES>. 
In a moment, I am going to start counting slowly back from twenty to one. During most of the 
count, you will still be in the deeply relaxed you are in. At the count of one, you will wake up 
and be fully awake, with your eyes open, in your normal waking state. After you wake up, you 
can allow the deep soothing feeling of comfort to stay with you inside your body. Your body will 
feel healthier inside in the coming days and weeks, like nothing can interfere with its feeling of 
healthy comfort. You will probably notice after your session today, that your intestines are more 
and more functioning with a healthy, steady comfortable rhythm that does not cause you 
problems, a healthy natural rhythm that does not disturb your comfort... You are always 
becoming more and more comfortable inside in all situations. 
After you wake up, you will feel fine and not have any unpleasant after-effects. You will feel 
relaxed and refreshed and comfortable inside after you wake up. Ready: Twenty ... nineteen... 
<CONTINUE SLOW COUNT BACKWARD>... three... now you are closer to waking up... 
two... now you are about to wake up ... one now you wake up and open your eyes. Fully awake. 
Wide awake. 
IBS Session Seven 
Please make yourself comfortable. Find a comfortable and relaxed position. And look up, like 
before, and find a spot on the ceiling to concentrate on. Let your body begin to relax... Relax 
your body. Relax all the muscles of your body. Allow it to become comfortably heavy and 
limp... Limp and loose. As I continue, and I count from one to three like always, your eyelids 
will gradually begin to feel heavier and will want to close, and when you feel that heaviness, you 
can just allow your eyelids to sink down and let your eyes close by themselves when they are 

 
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ready to close so you can drift into a comfortable hypnotic state. Just let it happen when you 
become relaxed and comfortable enough. One. Relax your body, allow it to become more and 
more limp and heavy ... comfortably limp. Allow the tension to evaporate from your muscles, 
making them soft and heavy. Soft ... and limp ... and heavy. As your body relaxes, it probably 
feels like it pushes down more and more into the chair as if it becomes weighted down, as your 
muscles go limp and let go of all the tension and you settle deeper into a state of relaxation. Two. 
Your body gradually settles into a deep and heavy state of relaxation as you focus on allowing 
the muscles to go limp and soft, your body limp and heavy, and you just concentrate effortlessly 
on what I am saying. Relax your body more and more. Your whole body more and more relaxed. 
Limp and loose and relaxed. Three. Relax your whole body. You can just allow your eyes to 
close completely now. Just let the eyes be completely closed, and allow yourself to let go ... let 
go and drift off into a comfortable state of hypnosis. Your body is gradually becoming very 
comfortably relaxed, but you can allow it to relax even further by letting your thoughts turn off 
all the tension in each body part as you think about it... Think about your fingers now... If you 
focus your attention, you can sense what the fingers feel like as they just lie there completely 
still. And as you do, let all the little muscles in your fingers relax even further... become soft and 
relaxed... the fingers can relax even further when you think about them relaxing or picture them 
in your mind relaxing. Your fingers may begin to feel a little numb as you let them relax more 
and more... as your fingers become limp and loose... or you may feel a little bit of a tingling 
sensation... or even a warm feeling in them, as they relax even more completely. And that is 
fine... whatever sensation you may feel coming into your fingers, simply tells you that your 
fingers are becoming completely relaxed... Allow this deep relaxation to come into your fingers 
and take over. Feel all the tension left in your fingers disappearing, making them totally relaxed. 
And now let this feeling of deep relaxation begin to spread up into your hands. Feel this deep 
relaxation spread through the muscles of your palms ... and over the back of your hands, making 
your hands heavy and totally relaxed ... heavy and totally relaxed. Every muscle in your hands 
becomes comfortably soft and loose. Make your hands totally relaxed. And let that feeling of 
relaxation spread on up your arms, maybe you can picture it in your mind or feel it in your arms, 
a wave of even more profound relaxation, deep, heavy relaxation, moving slowly up your arms, 
spreading through the muscles of your arms, automatically, making your arms more and more 
completely limp and loose... all the way up to your elbows your arms become heavy and limp 
and loose. Limp and heavy. And these waves of relaxation spread on, into your upper arms, 
making your upper arms also more and more limp and heavy. The heavy relaxation spreads all 
the way up your arms, up to your shoulders. All the way up to your shoulders, the arms relax, 
limp and comfortably heavy, just lying there comfortably heavy and loose like the arms of a rag 
doll. 
And feel the relaxation beginning to spread deep into your shoulders, making your shoulder 
muscles more comfortably soft and heavy ... relaxing all the muscles of your shoulders. Your 
shoulders become soft and loose. Soft and loose. And maybe you can feel a warm feeling 

 
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spreading through your shoulders also, as all the muscles in your shoulders become so soft and 
comfortably relaxed. And as we continue, and as you turn your attention to other things, your 
shoulders can continue to let go even more, continuing to relax even more deeply even when you 
pay no attention to it. It happens by itself. More and more, your body relaxes by itself. Let the 
relaxation spread down from your shoulders now down into your back... waves of relaxation 
flowing down through the muscles of your back, replacing any tension with a soft and soothing 
feeling of relaxation... the relaxation flows all the way down your back, relaxing the muscles of 
your back, easing up and loosening up any tension in your back... all the way down into your 
lower back. Feel the shoulders and back becoming even more comfortably relaxed... more and 
more relaxed... and now let the relaxation move further down your body... down into your thighs 
and down into your legs, moving all the way down into your feet, relaxing every body part on the 
way down, making the whole lower half of your body heavier and more comfortably relaxed. 
Limp and loose and relaxed. Your legs become more relaxed... the muscles of your legs become 
more and more soft and loose, and your feet also relax more. Relax your feet even further, let the 
right foot be totally relaxed.... relax your right foot completely... and now allow the left foot also 
to become totally relaxed. Both feet relax completely. Both feet deeply relaxed. 
Your entire body continues to become more thoroughly relaxed. All the muscles of your body 
relax even further, all over your body, relax even more deeply, as we continue. I am going to 
count now from one to twenty... and with each number, you can let yourself go deeper into the 
hypnotic state... deeper into a more comfortable and even more relaxing state of hypnosis. One, 
you go deeper down into this state of comfortable and carefree relaxation, deeper down... two... 
deeper down... more and more relaxed... three... four... you can let yourself go deeper into the 
hypnotic state with each number... five... deeper down... six... seven... deeper down into a 
carefree and comfortable state of hypnosis... eight... nine... ten... Just allow yourself to enjoy 
drifting away from all worries and concerns... eleven... twelve... let yourself sink safely down 
into a deep state of relaxed comfort... thirteen... fourteen... as you go deeper, your mind also 
relaxes more and more with each number... fifteen... sixteen... you go still deeper into a peaceful 
state of mental and physical relaxation... seventeen... eighteen... relax even more... nineteen... 
twenty. You are now deeply relaxed. Comfortably relaxed. I would now like to ask you, in this 
deeply relaxed state, to once again picture a comfortable place in your mind. Picture in your 
mind a comfortable place you know well, a place you are very familiar with, either currently or 
in your past experience, a place where you feel comfortable, happy and carefree. Let your mind 
choose a place to see in your mind's eye... a comfortable place you know. Allow the picture of 
this place to come into your mind so that you can recognize it. It may take a few moments for 
this to come into focus. And it doesn't matter what place you see, any place which is or has been 
very comfortable to you is fine. See this place in your mind. Imagine yourself in this place, in a 
way which is comfortable to you. Feel yourself in this place, and allow the comfort and 
relaxation of this place to fill you... As you picture yourself being in this place, it gradually 
becomes more and more vivid and clear to you. Notice the details of this place. See it clearly. 

 
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Notice the colors... the light. And notice the various details around you in this place... You may 
even be able to see things you have never noticed about this place... or see things you have 
forgotten about this place which make this a pleasant and comfortable place to be. Perhaps you 
can hear the sounds of this place if there are sounds... and maybe you can smell something if this 
place has a characteristic smell... Also notice whether it feels warm or cool in this place. Notice 
everything about this place and allow yourself to experience it as vividly as you can. And if you 
want to, you can reach out in your mind and touch something you see around you in this place... 
This is your own personal place of happy comfort and relaxation... Allow the happy relaxed 
feeling to come into you and fill you, as if you really are in this place. 
While you continue to experience the relaxed comfort of this place, seeing it and experiencing it 
more and more vividly, you can let your body continue to relax even more deeply by itself in the 
carefree and comfortable atmosphere of this place. When your body is so relaxed and your mind 
is so focused on the carefree feeling of this comfortable place, all discomfort fades away. After 
you wake up from this hypnotic state in a little while, you can keep this comfortable and healthy 
feeling in your body. Just like you know well the deep comfort of this familiar place, your body 
will more and more get to know the deep comfort of being relaxed and healthy inside. Your body 
will steadily feel healthier inside after you wake up from this state in a little while. Your body is 
becoming ever less and less sensitive to pain and discomfort in your bowels and intestines... 
More and more every day your intestines stay relaxed and comfortable and undisturbed no matter 
what goes on... functioning with a healthy comfortable rhythm that does not disturb your 
comfort, allowing you to go about your business of living without having to be troubled by upset 
in your intestines. You are becoming steadily more and more healthy and more comfortable until 
you feel no pain or discomfort inside anymore. All bowel pain and discomfort is disappearing 
from your life. Sensations that would have caused you discomfort and pain are now just soothing 
and comfortable. After your session today, all these healthy changes will happen more rapidly, 
until all bowel discomfort and upset simply disappears from your life.  
I would like to ask you now to let the image of your comfortable place fade away in your mind, 
as I start counting slowly backward from twenty to one. During most of the count, you can still 
be in the deeply relaxed state you are in now. But when I get down to the count of one, you will 
wake up and be fully awake, with your eyes open, in your normal state of wakefulness. You will 
feel fine and not have any uncomfortable after-effects. Ready now: Twenty... nineteen... 
<CONTINUE SLOW COUNT BACKWARD>... three... now you are closer to waking up... 
two... now you are about to wake up... one now you wake up and open your eyes. Fully awake. 
Wide awake. 

 
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APPENDIX C . GUT-DIRECTED HYPNOTHERAPY DAILY PRACTICE SESSION SCRIPT 
Make yourself comfortable in your seat. Find a position that you can keep without effort ... and 
just relax your body while you listen to my voice. Keep your thoughts on my words and picture 
in your mind the things that I am going to talk about. Allow my words to affect your mind and 
your body freely so that you can experience all the benefits from this exercise. 
As you allow your body to relax, I am now going to count slowly to three, and I will ask you to 
do different things at each number in the count Ready now ... One - look all the way up into your 
eyebrows, look up into your head as far up as you can go without straining your eyes too much, 
and keep your eyes up there, keep them still like that ... Two, and while you keep your eyes up 
there, close the eyelids slowly and take a deep breath, take a deep breath and hold your breath, 
hold it, hold it ... and three, now relax your eyes and breathe out slowly, and at the same time 
concentrate on the feeling of sinking, sinking down, sinking comfortably all the way down into 
the chair. 
It feels so good just to sit back and relax, and as you listen to my voice you can allow your body 
to become more and more heavy and relaxed, limp and loose and relaxed. Just let your body go 
limp and loose, more and more relaxed. 
Relax your eyes, allow the eyes to be comfortably relaxed ... relax your forehead ... and your 
jaws. Feel the tension evaporate from your jaws, your teeth, separating as the muscles in your 
jaw become more relaxed. Relax all the muscles in your face, making your face smooth and soft, 
your face smooth and soft and deeply relaxed. Feel the face relaxing more and more. Relax the 
muscles in your scalp and forehead, feel them becoming more and more smooth and soft, 
smoother and smoother as the relaxation deepens. 
As the tension leaves your body, you can start letting go of all the cares and all the concerns of 
the world. As you continue to enjoy deeper and deeper relaxation, you can allow yourself to drift 
away, drift far away from all your concerns and worries and simply enjoy this carefree state of 
comfort and ease. Nothing matters now, all you have to do is to listen to my words. Keep your 
thoughts on my words and allow my words the freedom to affect you in an automatic way. 
Let the deep relaxation you feel in your face and jaw spread down your body, making every body 
part limp and soft ... allow the relaxation to spread down your neck, making the muscles in the 
neck soft and comfortable. Relax your shoulders, let your shoulders sink down comfortably as 
the muscles become soft and loose ... Let the relaxation spill down into your chest, relaxing all 
the muscles of your chest, so you can breathe freely and deeply ... freely and slowly and deeply. 
As you continue to let your body go limp and loose, letting go of all your tension, you can also 
let go of all your cares. There is nothing to worry about now, nobody to please, you can let all 
your cares fade away, far away into the distance, as your body becomes more and more deeply 
relaxed and you listen lazily and comfortably to my words. 

 
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With every breath you breathe out you can relax even more as you sink down deeper and deeper 
into this relaxed state where nothing can bother you. Breathing out freely and rhythmically 
seems to allow you to sort of dissolve or melt into the chair. The chair is strong, it can hold your 
body safely as you sink deeper and deeper into this pleasant and relaxed state. 
Relax your shoulders, ... relax your upper back ... and your lower back. Feel the tension 
disappear from the muscles of your back, leaving only the comfortable sensation of relaxation. 
Relax the muscles of your stomach ... relax your stomach. 
As your muscles relax, you can also relax deep inside your body. Feel the relaxation spread deep 
into your stomach and flow down into your intestines, filling your intestines with a warm and 
soothing sense of comfort. You relax deeply inside, the comfort calms and soothes your bowels, 
making them less and less sensitive to upset or pain. It probably feels as if in this comfortable 
state you can only experience pleasant sensations, as if you cannot experience any discomfort, no 
pain and no discomfort. And as your body is gradually beginning to learn to maintain this deep 
soothing state of comfort inside, you can carry this comfort with you inside you whatever you 
are doing and wherever you are going. Every time you experience this deep soothing relaxation 
inside, your body learns better to maintain the comfort inside from day to day. 
Now relax your feet, let your feet relax ... from your toes, let the relaxation spread up your legs 
into your knees, ... and up into your thighs ... A feeling of comfortable heaviness and numbness 
grows stronger in your legs and feet as you settle even deeper into this pleasant state. As you 
continue to relax like that, you can perhaps imagine a nice warm blanket being drawn up over 
your body, all the way up to your chest. You may be able to feel a warm sensation in your limbs 
and perhaps a little tingling sensation coming into parts of your body as you relax even further. 
Allow your hands to relax even more, relax your fingers, and feel your hands and forearms 
becoming limp and heavy. More and more limp ... and heavy ... and comfortable. Relax your 
upper arms, all the muscles of your upper arms soft and relaxed. Just let the arms hang down 
limp and loose from your shoulders. 
Allow your whole body to be wrapped in this feeling of easy comfort, deeply relaxed, your 
whole body deeply relaxed. There is nothing to accomplish now, nothing to prove or worry 
about, you can just be yourself and enjoy this opportunity to let go while you sink down further 
into a deep state of comfort. 
I am going to be silent now for a minute, and you can just let your whole body continue to relax 
more and more deeply until I start talking again. Let your whole body sink deeper down into this 
carefree state of comfort, more and more relaxed all over until I start speaking to you again in a 
minute. 
<ONE MINUTE PAUSE> 

 
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In a moment, I am going to start counting slowly back from five to one. At the count of one you 
will be fully awake, with your eyes open, in your normal waking state. You will feel fine after 
you wake up, relaxed and refreshed, and you will not have any negative or uncomfortable after-
effects from this exercise... Ready now ... five ... four... three ... two ... now you are closer to 
waking up ... and one, open your eyes ... wide awake! Fully awake. 

 
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APPENDIX D MUSCLE RELAXATION SCRIPTS 
Session One 
Now let’s begin. Close your eyes and we will start your treatment.” 
The first exercise I want you to do is to tense the muscles in your RIGHT LOWER ARM and 
RIGHT HAND by making a fist and holding it until I tell you to release. Make a fist now, and 
clench it tightly and tense your RIGHT LOWER ARM at the same time and hold the tension in 
those muscles (narrator silent count 5 seconds), … and now release the tension in your muscles. 
As you tense your muscles study the tension in the back of your hand and in your right lower 
arm – notice what the tension feels like. Now I want you to repeat that tensing in your right fist 
and right lower arm, until I tell you to release. BEGIN and keep them tense … and notice what 
the tension feels like (narrator silent count for 5 seconds), and now release the tension in your 
muscles. 
Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
…………… 
What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles. 
Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 
seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 
for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 

 
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silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  
This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed.  
Next I want you to tense the muscles in your RIGHT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your right lower leg (narrator silent 
count 5 seconds), now release your muscles. Repeat this one more time and hold it until I tell you 
to release BEGIN (narrator silent count 5 seconds), now release your muscles.  
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 
count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 
relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. muscles. 
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release your muscles. 
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose.  
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds).  
Now I want you to tense the muscles in your ABDOMINAL REGION by drawing your stomach 
muscles in tightly without causing pain and hold it until I tell you to release BEGIN (narrator 

 
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silent count 5 seconds), now release abdominal muscles. Repeat this one more time and hold it 
until I tell you to release BEGIN (narrator silent count 5 seconds).  
Now, feel your muscles as they become loose and relaxed. 
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
Next I want you to tense the muscles AROUND YOUR MOUTH by pressing your lips together 
tightly without biting down and study the tensions in the region around your mouth. Hold the 
tension until I tell you to release BEGIN (narrator silent count 5 seconds), now release. Repeat 
this one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), 
and now release. 
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose.  
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 
seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 

 
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hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release.  
his time I want you to tense the muscles in your UPPER FOREHEAD by raising your eyebrows 
upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your forehead, and 
pay close attention to the tension in your upper forehead and hold the tension until I tell you to 
release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing how 
different they feel as they relax. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release. 
Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 
…………………………………………………… 3……………….4……………… 
……………………5.  
When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key.  
Session Two 
Now let’s begin. Close your eyes and we will start your treatment. 
The first exercise I want you to do is to tense the muscles in your RIGHT LOWER LEG, 
particularly in your calf and hold it until I tell you to release, BEGIN study the tensions in your 
right lower leg (narrator silent count 5 seconds), now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now release 
your muscles.  
What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles. 
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 
count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 

 
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relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles.  
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release your muscles. 
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed. 
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds). 
Next I want you to tense the muscles in your RIGHT LOWER ARM and RIGHT HAND by 
making a fist and holding it until I tell you to release. Make a fist now, and clench it tightly and 
tense your RIGHT LOWER ARM at the same time and hold the tension in those muscles 
(narrator silent count 5 seconds), … and now release the tension in your muscles. As you tense 
your muscles study the tension in the back of your hand and in your right lower arm – notice 
what the tension feels like. Now I want you to repeat that tensing in your right fist and right 
lower arm, until I tell you to release. BEGIN and keep them tense … and notice what the tension 
feels like (narrator silent count for 5 seconds), and now release the tension in your muscles. 
Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
………………..  
Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 
seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 

 
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for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 
silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  
This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
Now, feel your muscles as they become loose and relaxed. 
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed. 

 
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Now I want you to tense the muscles in your ABDOMINAL REGION by drawing your stomach 
muscles in tightly without causing pain and hold it until I tell you to release BEGIN (narrator 
silent count 5 seconds), now release abdominal muscles. Repeat this one more time and hold it 
until I tell you to release BEGIN (narrator silent count 5 seconds).  
Next I want you to tense the muscles AROUND YOUR MOUTH by pressing your lips together 
tightly without biting down and study the tensions in the region around your mouth. Hold the 
tension until I tell you to release BEGIN (narrator silent count 5 seconds), now release. Repeat 
this one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), 
and now release.  
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose.  
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 
seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release.  
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
This time I want you to tense the muscles in your UPPER FOREHEAD by raising your 
eyebrows upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your 
forehead, and pay close attention to the tension in your upper forehead and hold the tension until 
I tell you to release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing 
how different they feel as they relax. Repeat this one more time and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), and now release. 
Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 

 
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…………………………………………………… 3……………….4……………… 
……………………5.  
When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key. 
Session Three 
Now let’s begin. Close your eyes and we will start your treatment. 
The first exercise I want you to do is to tense the muscles AROUND YOUR MOUTH by 
pressing your lips together tightly without biting down and study the tensions in the region 
around your mouth. Hold the tension until I tell you to release BEGIN (narrator silent count 5 
seconds), now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles. 
muscles. 
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 
seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release.  
This time I want you to tense the muscles in your UPPER FOREHEAD by raising your 
eyebrows upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your 
forehead, and pay close attention to the tension in your upper forehead and hold the tension until 
I tell you to release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing 
how different they feel as they relax. Repeat this one more time and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), and now release. 
 

 
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Now I want you to tense the muscles in your ABDOMINAL REGION by drawing your stomach 
muscles in tightly without causing pain and hold it until I tell you to release BEGIN (narrator 
silent count 5 seconds), now release abdominal muscles. Repeat this one more time and hold it 
until I tell you to release BEGIN (narrator silent count 5 seconds). Release your muscles.  
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed.  
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release.release your muscles. 
 to tense the muscles in your RIGHT LOWER ARM and RIGHT HAND by making a fist and 
holding it until I tell you to release. Make a fist now, and clench it tightly and tense your RIGHT 
LOWER ARM at the same time and hold the tension in those muscles (narrator silent count 5 
seconds), … and now release the tension in your muscles. As you tense your muscles study the 
tension in the back of your hand and in your right lower arm – notice what the tension feels like. 
Now I want you to repeat that tensing in your right fist and right lower arm, until I tell you to 
release. BEGIN and keep them tense … and notice what the tension feels like (narrator silent 
count for 5 seconds), and now release the tension in your muscles. 
Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
………… 

 
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Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 
seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 
for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 
silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  
This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
Now, feel your muscles as they become loose and relaxed. 
Next I want you to tense the muscles in your RIGHT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your right lower leg (narrator silent 
count 5 seconds), now release your muscles. Repeat this one more time and hold it until I tell you 
to release BEGIN (narrator silent count 5 seconds), now release your muscles.  
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 

 
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count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 
relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now  
release your muscles. 
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose. 
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds).  
Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 
…………………………………………………… 3……………….4……………… 
……………………5.  
When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key. 
Session Four 
Now let’s begin. Close your eyes and we will start your treatment.” 
The first exercise I want you to do is to tense the muscles in your ABDOMINAL REGION by 
drawing your stomach muscles in tightly without causing pain and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release abdominal muscles. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds). 

 
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What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles 
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed. 
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose.  
Next I want you to tense the muscles in your RIGHT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your right lower leg (narrator silent 
count 5 seconds), now release your muscles. Repeat this one more time and hold it until I tell you 
to release BEGIN (narrator silent count 5 seconds), now release your muscles.  
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 
count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 
relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. 
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 

 
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release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds). release your muscles.  
Now, feel your muscles as they become loose and relaxed. 
Now I want you to tense the muscles in your RIGHT LOWER ARM and RIGHT HAND by 
making a fist and holding it until I tell you to release. Make a fist now, and clench it tightly and 
tense your RIGHT LOWER ARM at the same time and hold the tension in those muscles 
(narrator silent count 5 seconds), … and now release the tension in your muscles. As you tense 
your muscles study the tension in the back of your hand and in your right lower arm – notice 
what the tension feels like. Now I want you to repeat that tensing in your right fist and right 
lower arm, until I tell you to release. BEGIN and keep them tense … and notice what the tension 
feels like (narrator silent count for 5 seconds), and now release the tension in your muscles. 
Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
………… 
Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 
seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 
for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 

 
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silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  
This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
Next I want you to tense the muscles AROUND YOUR MOUTH by pressing your lips together 
tightly without biting down and study the tensions in the region around your mouth. Hold the 
tension until I tell you to release BEGIN (narrator silent count 5 seconds), now release. Repeat 
this one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), 
and now release.  
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose. 
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 
seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
This time I want you to tense the muscles in your UPPER FOREHEAD by raising your 
eyebrows upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your 
forehead, and pay close attention to the tension in your upper forehead and hold the tension until 
I tell you to release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing 
how different they feel as they relax. Repeat this one more time and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), and now release. 

 
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Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 
…………………………………………………… 3……………….4……………… 
……………………5.  
When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key. 
Session Five 
Now let’s begin. Close your eyes and we will start your treatment.” 
 
The first exercise I want you to do is to tense the muscles in your RIGHT LOWER ARM and 
RIGHT HAND by making a fist and holding it until I tell you to release. Make a fist now, and 
clench it tightly and tense your RIGHT LOWER ARM at the same time and hold the tension in 
those muscles (narrator silent count 5 seconds), … and now release the tension in your muscles. 
As you tense your muscles study the tension in the back of your hand and in your right lower 
arm – notice what the tension feels like. Now I want you to repeat that tensing in your right fist 
and right lower arm, until I tell you to release. BEGIN and keep them tense … and notice what 
the tension feels like (narrator silent count for 5 seconds), and now release the tension in your 
muscles. 
Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
……… 
What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles. 
Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 

 
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seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 
for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 
silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  
This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed.  
Next I want you to tense the muscles in your RIGHT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your right lower leg (narrator silent 
count 5 seconds), now release your muscles. Repeat this one more time and hold it until I tell you 
to release BEGIN (narrator silent count 5 seconds), now release your muscles.  
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 
count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 
relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 

 
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one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles 
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose. 
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds). release your muscles. 
Now I want you to tense the muscles in your ABDOMINAL REGION by drawing your stomach 
muscles in tightly without causing pain and hold it until I tell you to release BEGIN (narrator 
silent count 5 seconds), now release abdominal muscles. Repeat this one more time and hold it 
until I tell you to release BEGIN (narrator silent count 5 seconds). 
Now, feel your muscles as they become loose and relaxed. 
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed.  
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
Next I want you to tense the muscles AROUND YOUR MOUTH by pressing your lips together 
tightly without biting down and study the tensions in the region around your mouth. Hold the 
tension until I tell you to release BEGIN (narrator silent count 5 seconds), now release. Repeat 

 
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this one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), 
and now release. 
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose. 
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 
seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
This time I want you to tense the muscles in your UPPER FOREHEAD by raising your 
eyebrows upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your 
forehead, and pay close attention to the tension in your upper forehead and hold the tension until 
I tell you to release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing 
how different they feel as they relax. Repeat this one more time and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), and now release. 
Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 
…………………………………………………… 3……………….4……………… 
……………………5. 
When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key.  

 
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Session Six 
Now let’s begin. Close your eyes and we will start your treatment.” 
The first exercise I want you to do is to tense the muscles in your RIGHT LOWER LEG, 
particularly in your calf and hold it until I tell you to release, BEGIN study the tensions in your 
right lower leg (narrator silent count 5 seconds), now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now release 
your muscles.  
What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles. 
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 
count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 
relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. 
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed. 
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds).  
Next I want you to tense the muscles in your RIGHT LOWER ARM and RIGHT HAND by 
making a fist and holding it until I tell you to release. Make a fist now, and clench it tightly and 
tense your RIGHT LOWER ARM at the same time and hold the tension in those muscles 
(narrator silent count 5 seconds), … and now release the tension in your muscles. As you tense 
your muscles study the tension in the back of your hand and in your right lower arm – notice 
what the tension feels like. Now I want you to repeat that tensing in your right fist and right 
lower arm, until I tell you to release. BEGIN and keep them tense … and notice what the tension 
feels like (narrator silent count for 5 seconds), and now release the tension in your muscles. 

 
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Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
……… 
Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 
seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 
for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 
silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  
This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 

 
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release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
Now, feel your muscles as they become loose and relaxed. 
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed. 
Now I want you to tense the muscles in your ABDOMINAL REGION by drawing your stomach 
muscles in tightly without causing pain and hold it until I tell you to release BEGIN (narrator 
silent count 5 seconds), now release abdominal muscles. Repeat this one more time and hold it 
until I tell you to release BEGIN (narrator silent count 5 seconds). 
Next I want you to tense the muscles AROUND YOUR MOUTH by pressing your lips together 
tightly without biting down and study the tensions in the region around your mouth. Hold the 
tension until I tell you to release BEGIN (narrator silent count 5 seconds), now release. Repeat 
this one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), 
and now release. 
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose.  
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 
seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 

 
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hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
This time I want you to tense the muscles in your UPPER FOREHEAD by raising your 
eyebrows upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your 
forehead, and pay close attention to the tension in your upper forehead and hold the tension until 
I tell you to release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing 
how different they feel as they relax. Repeat this one more time and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), and now release. 
Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 
…………………………………………………… 3……………….4……………… 
……………………5.  
When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key.  
Session Seven 
Now let’s begin. Close your eyes and we will start your treatment.” 
The first exercise I want you to do is to tense the muscles AROUND YOUR MOUTH by 
pressing your lips together tightly without biting down and study the tensions in the region 
around your mouth. Hold the tension until I tell you to release BEGIN (narrator silent count 5 
seconds), now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
What we are doing is teaching your brain to distinguish better and better between a state of 
tension and relaxation in different muscle groups by paying close attention to the contrast in 
sensations, so that the brain becomes more effective at releasing all tension from those muscles. 
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly BEGIN. Notice what the tension feels like around your eyes and in your upper face, 
study those tensions and hold the tension until I tell you to release (narrator silent count 5 

 
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seconds) now release. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
This time I want you to tense the muscles in your LOWER FOREHEAD by frowning and 
pushing your eyebrows downward. Frown and knit your eyebrows together. BEGIN Pay close 
attention to the tension around your eyes and in your lower forehead study those tensions until I 
tell you to release (narrator silent count 5 seconds), now release. Repeat this one more time and 
hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
This time I want you to tense the muscles in your UPPER FOREHEAD by raising your 
eyebrows upward and wrinkling your forehead. Lift your eyebrows up high, Wrinkling your 
forehead, and pay close attention to the tension in your upper forehead and hold the tension until 
I tell you to release, BEGIN (narrator silent count 5 seconds) and now relax the muscles, noticing 
how different they feel as they relax. Repeat this one more time and hold it until I tell you to 
release BEGIN (narrator silent count 5 seconds), and now release. 
Now I want you to tense the muscles in your ABDOMINAL REGION by drawing your stomach 
muscles in tightly without causing pain and hold it until I tell you to release BEGIN (narrator 
silent count 5 seconds), now release abdominal muscles. Repeat this one more time and hold it 
until I tell you to release BEGIN (narrator silent count 5 seconds). 
As you work on your muscles, notice how you can feel your muscles becoming loose and soft 
and relaxed.  
Next I want you to tense the muscles in your CHEST by taking in a deep breath and holding it 
BEGIN. Hold your breath (narrator silent count 5 seconds) now let it out slowly. And now, let 
your breathing be regular and relaxed.. Repeat this one more time when I tell you to begin, 
taking a deep breath and holding it until I tell you to release it BEGIN (narrator silent count 5 
seconds), and now breathe out … and then letting your breathing be regular and relaxed. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears and holding them tense like that until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Repeat this one more 
time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), and now 
release. And feel the sensation of relaxation that comes into the shoulders and upper back and 
how it is different than the tension you felt before. 
You can feel the comfortable sensation of your muscles relaxing and as the tension in your 
muscles resolves and they become soft and loose. 
Next I want you to tense the muscles in the BACK OF YOUR NECK by pressing your head 
against the headrest of your chair or into the bed, and keep those muscles tense until I tell you to 
release BEGIN (narrator silent count 5 seconds), now release. Repeat this one more time and 

 
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hold the tension steady until I tell you to release BEGIN (narrator silent count 5 seconds), and 
now release. 
 to tense the muscles in your RIGHT LOWER ARM and RIGHT HAND by making a fist and 
holding it until I tell you to release. Make a fist now, and clench it tightly and tense your RIGHT 
LOWER ARM at the same time and hold the tension in those muscles (narrator silent count 5 
seconds), … and now release the tension in your muscles. As you tense your muscles study the 
tension in the back of your hand and in your right lower arm – notice what the tension feels like. 
Now I want you to repeat that tensing in your right fist and right lower arm, until I tell you to 
release. BEGIN and keep them tense … and notice what the tension feels like (narrator silent 
count for 5 seconds), and now release the tension in your muscles. 
Notice the difference between the tension and the 
relaxation.…………………………………………………………………………………………
………… 
Next I want you to tense the muscles in your LEFT LOWER ARM and LEFT HAND by making 
a fist and holding it until I tell you to release. BEGIN. Study the tensions in the back of your 
hand and in your left lower arm, Notice what those tensions feel like. (narrator silent count for 5 
seconds) and now release the muscles. Notice the difference in your muscles between the tension 
and the relaxation. Now I want you to repeat that until I tell you to release. BEGIN (narrator 
silent count for 5 seconds), and now release your muscles. And feel how the relaxed muscles feel 
different than when you were keeping them tense. 
Now this time I want you to tense BOTH FOREARMS AND BOTH HANDS at the same time 
and hold the tension steady until I tell you to release it. BEGIN Study the tensions in the back of 
your hands and in your lower arms, Notice what the tensions feel like (narrator silent count 5 
seconds) and now release the muscles. Notice the difference between the tension and the 
relaxation. Now I want you to repeat that until I tell you to release BEGIN (narrator silent count 
for 5 seconds), and now release your muscles … paying close attention to what the relaxation 
feels like. 
This time I want you to tense the muscles in your RIGHT UPPER ARM by bringing your right 
hand up towards your shoulder and tensing the biceps muscle and hold it until I tell you to 
release. BEGIN Study the tensions in the muscles of your arm study those tensions (narrator 
silent count 5 seconds) and then release the muscles. Now I want you to repeat that until I tell 
you to release BEGIN (narrator silent count for 5 seconds), and now release your muscles.  
This time I want you to tense the muscles in your LEFT UPPER ARM by bringing your left hand 
up towards your shoulder and tensing the biceps muscle until I tell you to release. BEGIN Study 
the tensions in the muscles of your arm, study those tensions (narrator silent count 5 seconds) 
and now release the muscles. Now I want you to repeat that until I tell you to release BEGIN 
(narrator silent count 5 seconds), now release your muscles.  

 
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This time I want you to tense the muscles in BOTH UPPER ARMS at the same time BEGIN 
Study the tensions in in your upper arms, study those tensions (narrator silent count 5 seconds) 
and then release the muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (narrator silent count 5 seconds), and now release your muscles. Notice the difference 
between the tension and the relaxation.  
Now, feel your muscles as they become loose and relaxed. 
Next I want you to tense the muscles in your RIGHT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your right lower leg (narrator silent 
count 5 seconds), now release your muscles. Repeat this one more time and hold it until I tell you 
to release BEGIN (narrator silent count 5 seconds), now release your muscles.  
Next I want you to tense the muscles in your LEFT LOWER LEG, particularly in your calf and 
hold it until I tell you to release, BEGIN study the tensions in your left lower leg (narrator silent 
count 5 seconds), now release your muscles. Remember, When tensing your muscles, and then 
relaxing them, study the difference in feeling between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now  
release your muscles. 
By now, the various muscles that you have been working on should be feeling more loose and 
relaxed than before, and you can let them stay that way … comfortably soft and loose.  
This time I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you 
release, BEGIN study the tensions in your lower legs (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds), and now release. 
Next I want you to tense the muscles in your THIGHS by pressing your legs together from the 
knee upward and hold it until I tell you to release BEGIN (narrator silent count 5 seconds), now 
release your muscles. Repeat this one more time and hold it until I tell you to release BEGIN 
(narrator silent count 5 seconds). release your muscles. 
Now I want you to tense all of the muscles in your body and hold the tension steady until I tell 
you to release BEGIN (narrator silent count 5 seconds), now relax all the muscles in your body 
together. Just let them release all the tension and become soft and relaxed. Notice how your body 
feels different now that it lets go of all the tension, and all the muscles become soft and loose. I 
am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you can let muscles all over your body becoming even more soft and loose.  
1…………………your muscles are feeling more soft and relaxed, 
…………………..2………………..your muscles are releasing any remaining tension 
…………………………………………………… 3……………….4……………… 
……………………5.  

 
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When you are ready you can get yourself back into a normal state. Remember, only through 
practice can your brain become more aware of your muscles, how they respond to tension and 
how you can relax them. Training your muscles to respond differently is like any training. 
Practicing consistently is the key.  

 
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APPENDIX E.  
MUSCLE RELAXATION DAILY PRACTICE SESSION SCRIPT 
Now let’s begin. Close your eyes and we will begin the exercise.” 
First, I want you to tense BOTH ARMS AND BOTH HANDS together,. Keep the tension and 
now bend your arms at the elbow. BEGIN Study the tensions in the back of your hands and in 
your lower arms………………study those tensions (Narrator count 5 seconds) now RELAX 
your arms and hands. Notice the difference between the tension and the relaxation. Repeat this 
one more time and hold it until I tell you to release BEGIN (Narrator count 5 seconds), now 
release your muscles. 
Next I want you to tense BOTH LOWER LEGS at the same time and hold it until I tell you to 
release, BEGIN, remember to study the tensions in your lower legs (Narrator count 5 seconds), 
now release your muscles. Repeat this one more time and hold it until I tell you to release 
BEGIN (Narrator count 5 seconds), now release your muscles. 
Next I want you to tense the muscles in your SHOULDERS and UPPER BACK by hunching 
your shoulders up towards your ears. BEGIN Study those tensions across your upper 
back………………….study those tensions (Narrator count 5 seconds) now relax the muscles. 
Study the difference between the tension and the relaxation. Repeat this one more time and hold 
it until I tell you to release BEGIN (Narrator count 5 seconds), now release your muscles. 
This time I want you to tense the muscles in the region around your EYES by closing your eyes 
very tightly. BEGIN Just close your eyes tightly and study the tension around your eyes and 
upper face (Narrator count 5 seconds) then RELAX the muscles. Notice the difference between 
the tension and the relaxation. Repeat this one more time and hold it until I tell you to release 
BEGIN (Narrator count 5 seconds), now release your muscles. 
Now I want you to tense all of the muscles in your body and hold it until I tell you to release 
BEGIN (Narrator count 5 seconds), now relax all the muscles in your body together. Just let 
them become more and more relaxed. Repeat this one more time and hold it until I tell you to 
release BEGIN (Narrator count 5 seconds), now release your muscles. 
I am going to help you achieve a deeper state of muscle relaxation now by counting from 1 to 5. 
As I count you will feel the muscles all over your body becoming soft and loose.  
1…………………your muscles are feeling soft, …………………..2………………..your 
muscles are deeply relaxed…………………………………………………… 
3……………….4……………… ……………………5.  
When you are ready you can get yourself back into a normal state. 
 

 
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APPENDIX F GDH INTRO SCRIPT 
Implementation notes: 
1. The intro video will be played before the first treatment (no option to opt out).  
2. Starting with Session 2, intro video will be accessible from a button/link near the large 
video play button (opt-in to watch).  
3. The intro video will also be accessible from the help section of the app. 
Intro Script (sentences in italics indicate GDH-specific text): 
Welcome and thank you for participating in this important clinical study. Your treatment session 
will begin after this two-minute introductory video. Your treatment program will consist of seven 
30-minute sessions, with two weeks between each session. You will be sent an email reminder 24 
hours and 1 hour before each of your sessions, and a text message reminder 5 minutes before each 
of your sessions. It is important to do your treatment session on the day that it is scheduled. If you 
do miss a session, you will be notified by email. If you know in advance that you can’t make your 
scheduled session time, you may re-schedule it in your app. All treatment sessions must be 
completed within 3 days of the originally scheduled date. 
On days you don’t have a treatment session, a “practice” session will be available to you. A 
minimum of three practice sessions per week is recommended, but you may complete a practice 
session every day you don’t have a treatment session. You can always access your treatment or 
practice sessions by logging into this app. To play your treatment or practice session, press the 
large arrow-button on your app. The button is designed to always play the correct treatment or 
practice session.  
If you are interrupted for any reason during your session, it’s best to start over from the 
beginning. To do this, you may press the “begin again” button at any time. You may restart each 
of your sessions up to three times. When you successfully complete a session, press the 
“complete session” button.  
Relaxation can improve gut symptoms. That’s why during your sessions, it is important to be in a 
quiet place where you can sit comfortably and will not be disturbed. Be sure to place your phone 
in “Do Not Disturb” mode. Choose a place you can adjust the lights so that they are not too bright, 
and a place with a good wifi or cellular network connection. If possible, loosen any restrictive 
clothing. We recommend using headphones, earbuds, or quality speakers. Never view or listen to 
your sessions in a car, even if it is not moving.  
If after completing your session you still feel like you are not fully alert, it is ok to sit for another 
few minutes before getting up. Thank you again for participating in this study. 

 
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APPENDIX G 
MUSCLE RELAXATION INTRO SCRIPT 
Implementation notes: 
1. The intro video will be played before the first treatment (no option to opt out).  
2. Starting with Session 2, intro video will be accessible from a button/link near the large 
video play button (opt-in to watch).  
3. The intro video will also be accessible from the help section of the app. 
Welcome and thank you for participating in this important clinical trial. Your treatment session 
will begin after this 2-minute introductory video.  
Your treatment program will consist of seven 30-minute sessions, with 2 weeks between each 
session. An email reminder will be sent to you 24 hours and 1 hour before each of your sessions. 
And a text message reminder will be sent to you 5 minutes before each of your sessions.  
It’s important to do your treatment session on the day that it’s scheduled. If you miss a session, 
you’ll be notified by email. If you know in advance that you cannot make a scheduled session, 
you may re-schedule it in this app. But all treatment sessions must be completed within 3 days of 
the originally scheduled date. 
On days when you don’t have a treatment session, a “practice” session will be available. A 
minimum of 3 practice sessions between treatment sessions is recommended. You may complete 
a practice session on any day that you don’t have a treatment session.  
You can always access your treatment or practice sessions by logging into this app. To play your 
treatment or practice session, press the large arrow button in the app. It will always play the 
correct treatment or practice session. 
If you’re interrupted during a session, it’s best to start over from the beginning. To do this, press 
the “Begin Again” button at any time. You may restart each session up to 3 times.  
When you successfully complete a session, press the “complete session” button.  
Relaxation can improve gut symptoms. That’s why it is important to find a comfortable position 
for your sessions, preferably lying in a recliner or on a bed. Be sure you’re in a quiet place where 
you won’t be disturbed. And put your phone in “Do Not Disturb” mode. If possible, loosen any 
tight or restrictive clothing. Choose a place where you can adjust the lights so they’re not too 
bright, and someplace with a good Wi-Fi or cellular network connection. Place your smartphone 

 
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or mobile device close enough so you can hear it. Or better yet, use headphones, earbuds, or 
quality speakers. Never listen to your sessions in a car, even if it’s not moving. 
If you ever have any muscle discomfort during your session, immediately release and relax the 
muscle. If you have discomfort with a muscle group, you may choose not to try that muscle 
group again and wait until the session takes you to the next muscle group. Thank you again for 
participating in this trial.