Digital Clinical Hypnosis for Chronic Pain Management
Phase: NA
Conditions: Chronic Low-back Pain, Chronic Pain
Sponsor: University of Washington

Study Protocol and Statistical Analysis Plan 
 
Title: Digital Clinical  Hypnosis for Chronic Pain Management 
NCT number:  NCT06050083 
Document date: 08/21/2025 
 

Study Protocol 
Overview of Study 1 and Study 2  
This protocol describes two studies that are a part of this project. They use the same 
experimental design to evaluate the feasibility of the digital program. The primary 
difference is that first study (Study 1) recruits individuals with chronic low back pain and 
the second (Study 2) recruits individuals with general chronic pain (which includes 
individuals with chronic low back pain as well as individuals with chronic pain as a 
secondary condition to another health problem, such as spinal cord injury). Both studies 
aim to enroll 50 participants, which, given an estimated 20% dropout rate, would allow 
for complete data from at least 40 participants in each study.  
Both studies use a 2-arm prospective randomized controlled trial design to evaluate 
the feasibility of the program (called Rose) over an 8-week period. Participants are 
randomly assigned to one of two groups: Rose access for a full 8 weeks (Access group) 
or Rose access for 4 weeks (Waitlist control group). The Waitlist group will not have 
access to Rose for the first 4 weeks of the study and then have access to Rose for the 
final 4 weeks. The 4-week assessment point is the primary study endpoint. Primary 
(feasibility) and secondary (clinical) outcomes using the Rose program and self-report 
measures using the Research Electronic Data Capture (REDCap) program, hosted by 
the University of Washington Institute of Translational Health Sciences (ITHS). 
Participants complete the self-report measures at three timepoints: baseline (before 
randomization), 4 weeks after randomization (primary endpoint), and 8 weeks after 
randomization. 
Measures 
Feasibility. The studies has five primary feasibility outcome domains: (1) frequency 
of listening to a hypnosis session; (2) participant satisfaction with Rose; (3) interest in 
having continued access to Rose after study completion; (4) willingness to pay for that 
continued access; and (5) system usability. For each feasibility outcome, we have a 
priori specific criteria for determining if Rose was feasible. 
Frequency of access. The Rose application tracks how frequently participants 
listened to a session. In this domain, we propose that Rose would be feasible if at least 
50% of the Access participants who were offered access to Rose used it at least 
once/week. This criterion was selected as clinical hypnosis sessions are usually 
scheduled to occur once/week, making this frequency a standard for this treatment.  
Satisfaction with Rose. We assess satisfaction with Rose at the 4-week timepoint 
(i.e. 4-weeks after randomization) using a 5-point global treatment satisfaction scale 
(“Taking all things into account, how satisfied are you with using the Rose web 
application?”), whose response options ranged from 1 (“Very satisfied") to 5 (“Very 
dissatisfied”), or “Prefer not to Answer.” We determined that Rose would be feasible if ≥ 
50% of the participants who listened to at least one Rose session would rate being 
either “Somewhat satisfied” or “Very satisfied” with Rose.  
Interest in continued Rose access. We assess interest in continued access to 
Rose by asking, that if the program were available, "... how interested would you be in 
downloading and using this application?" Participants respond to this question using a 
5-point Likert scale ranging from 0 = "I would not be interested" to 5 = "I would be 
extremely interested.” We determined that Rose would be feasible if ≥ 50% of the 

Access group participants who used Rose per protocol (i.e., at least 4 times during the 
four weeks after randomization) rated themselves as being at least "... a little interested" 
in using Rose. 
Willingness to pay for access to Rose. We also assess participants’ willingness to 
pay for continued Rose access after finishing the study. However, after the study began, 
we discovered that the question had been phrased incorrectly. The error was corrected 
when the error was discovered, but most of the Study 1 participants and four of the 
Study 2 had responded to the incorrectly worded question when the question was 
corrected. We therefore present the findings for this question only for the Study 2 
participants in the Study 2 participants in the Access group who used Rose per protocol. 
We determined a priori that Rose would be feasible if ≥ 40% of the Access group 
participants who used Rose per protocol endorsed a willingness to pay for continued 
access. 
Usability. Finally, we assess the usability of Rose using the System Usability Scale 
(SUS)(Lewis, 2018), a common 10-item measure of the overall usability of applications 
(sample item, “I thought the product was easy to use”). The cutoff we selected as the 
minimum average needed to determine that Rose was feasible was a score of ≥ 68, 
which is the average SUS score across a large variety of software products (i.e., if 
Rose's SUS score is ≥ 68, it has an above average level of usability; (Banger, Kortum, & 
Miller, 2008)). 
 Secondary outcomes: Changes in clinical domains. Study 1 and Study 2 were 
both feasibility studies and are therefore not powered to detect statistically significant 
effects on any clinical outcome. However, the primary purpose of Rose is to improve 
pain-related quality of life domains for individuals who access and listen to Rose's 
sessions, and these two feasibility studies were designed to provide data which could 
be used to inform a full clinical trial, if Rose is found to be feasible. A secondary aim of 
the two feasibility studies was therefore to provide preliminary estimates of the effects of 
Rose on a number of pain-related clinical outcomes to: (1) determine if anticipated 
improvements in these outcomes could be observed and, if so, to help (2) identify (a) 
the outcome domains that should be assessed in a fully-powered clinical trial, and (b) 
the measures that should be used to assess those domains in such a clinical trial. 
 
We assess six clinical outcome domains: (1) immediate (i.e., pre- to post-
session) changes in pain intensity; (2) change in average pain intensity from baseline 
(i.e., at randomization) to four weeks after randomization (primary endpoint) and to eight 
weeks after randomization (secondary endpoint); (3) change in pain interference from 
baseline to 4-weeks and from baseline to 8-weeks; (4) change in anxiety from baseline 
to 4-weeks and baseline to 8-weeks; (5) change in sleep disturbance from baseline to 4-
weeks and baseline to 8-weeks; and (6) change in opioid use from baseline to 4-weeks 
and baseline to 8-weeks after randomization. 
 
We measure pain intensity for the first two clinical outcomes using a 0-10 
Numerical Rating Scales (NRS) of pain intensity. The endpoints of the NRSs used here 
were 0 = "No pain" and 10 = "Pain as bad as you can imagine." NRSs have a great deal 
of evidence supporting their reliability and validity as measures of pain intensity 
(Jensen, 2018) and are recommended over other ratings scale in pain clinical trials 
(Dworkin et al., 2005). To assess immediate changes in pain intensity associated with 

listening to a Rose session, the Rose application prompts participants with a 
screen/question asking participants to rate their current pain on the 0-10 NRS just 
before and just after each listening session that included hypnotic suggestions for 
comfort. To assess change in average pain intensity from baseline to the 4-week and 
the 8-week assessment points, participants are asked to rate their "Average pain 
intensity in the past week" with the NRS at baseline (immediately after randomization), 
and then 4- and 8-weeks after randomization.  
 
Pain interference, anxiety, and sleep disturbance at baseline, week 4, and week 
8 are assessed by administering the Patient Reported Outcomes Measurement 
Information System (PROMIS) 8-item short form scales assessing these domains 
(PROMIS, 2024). PROMIS measures ask respondents to consider the magnitude or 
frequency of each symptom in the past seven days listed on the short forms using 5-
point Likert scales with the response options responses varying as a function of the item 
(e.g., for magnitude, "Not at all" to "Very much"; for frequency, "Never" to "Always"). 
Responses are summed and then transformed to T-scores with a mean of 50 and a SD 
of 10 in the normative samples. All PROMIS measures are scored such that higher 
scores indicate higher levels of the domain being assessed (i.e., here, more pain 
interference, anxiety, or sleep disturbance). Evidence supports the validity and reliability 
of each of these measures in a variety of clinical populations, including individuals with 
chronic pain (Bhandari et al., 2022; Chimenti et al., 2021). The baseline internal 
consistencies (Cronbach's alphas) for these measures were: .95, .95, and .90 for Study 
1 and .93, .86. .91 for Study 2 the PROMIS Pain Interference (8-item Short Form), 
PROMIS Anxiety (8-item Short Form), and PROMIS Sleep Disturbance (8-item Short 
Form) scales, respectively.  
 
Opioid use is assessed by a self-report question asking participants if they are 
taking any opioid medications (with opioid examples listed, such as oxycodone, 
hydrocodone, and fentanyl). If the participant responded "Yes," a sub-question 
appeared asking for: medication name, dosage, and frequency of use in the past seven 
days. These participant responses were then converted to Morphine Milligram 
Equivalents (MME), which refers to “the amount of morphine that an opioid dose is 
equal to when [the opioid is] prescribed.” MME converts different opioid medication 
dosages into a single unit and is calculated by comparing the results from two publicly 
available MME calculators (Hudson et al., 2018). 
Procedures 
Consent and enrollment 
Study 1 (Chronic Low Back Pain). The Study 1 participants are recruited using 
Research Match, a national research participant registry managed by the National 
Institute of Health. We use a multi-step recruitment process to identify eligible 
participants and focus on recruiting a racially diverse sample. First, we set the Research 
Match location filters to be anywhere in the United States, health condition filters to 
'"Chronic Low Back Pain," demographic filters to any sex/gender, and race/ethnicity 
filters to all non-White or Hispanic/Latinx individuals. After screening and enrolling 
participants from this first recruitment wave, we evaluate how close we were to our 
recruitment goals for sex and race. Our goal is to have racial diversity that is at or above 
average racial diversity percentages for the Seattle metropolitan area. That is: ≤ 47% 

White Non-Latino/Latina, ≥ 11% Asian, ≥ 6% Black or African American, and ≥10% 
More than one Race, and self-identified ethnicity (goal: ≥ 6% Hispanic or Latinx). Next, 
we adjust the Research Match filters to include White/Caucasian, Non-Hispanic Latinx 
adults until we reached our recruitment goal of N = 50. Potentially eligible participants 
received a study email invitation from Research Match with a link to our online REDCap 
screening form. The online screening form provided a UW Institutional Review Board 
(IRB) approved study summary and collected participants' contact information and 
screening question responses. 
The Study 1 screening form assesses for all study inclusion and exclusion criteria 
except for exclusion criteria (1), (2), and (3), which are assessed via telephone interview 
later. The inclusion criteria include: (1) 18 years old or older; (2) self-reported chronic 
low back pain (i.e., pain in the low back that has been ongoing for 3 months or more; 
and occurs on at least half the days in the past 3 months); (3) average pain intensity in 
the past week of ≥ 4 on a 0-10 scale, where 0 = “No Pain” and 10 = “Pain as bad as you 
can imagine”; (4) reads, speaks, and understands English; (5) regular access to the 
internet per self-report; and (6) access to a device (smartphone, desktop, laptop, tablet, 
etc.) that can connect to the internet. The study exclusion criteria include: (1) history or 
current diagnosis of primary psychotic or major thought disorder (i.e. Schizophrenia, 
Psychosis, Bipolar Disorder) with current active symptoms such as active delusional or 
psychotic thinking (self-report) within the past 5 years per self-report; (2) psychiatric 
hospitalization within the past 6 months per self-report; (3) psychiatric or behavioral 
conditions, including active suicidal ideation or intent to harm oneself or others, in which 
symptoms were unstable or severe within the past 6 months as disclosed during self-
report screening; (4) active malignancy (e.g., cancer not in remission) or actively in 
cancer treatment per self-report; (5) planned surgery in the next six months that is 
related to the back pain per self-report; and (6) currently receiving or have received 
hypnosis treatment for any pain condition per self-report. 
Potential participants who met the inclusion and exclusion criteria based on the 
REDCap screening form are contacted by study staff via telephone within 2 days of staff 
receiving a REDCap notification of a completed online screening form. During the 
phone call, study staff administer questions to assess the potential participant’s history 
or current diagnosis of primary psychotic or major thought disorder, whether they had 
been hospitalized for a psychiatric treatment within the past 6 months, and the presence 
of active suicidal ideation or intent to harm oneself or others. Participants that endorse a 
history of being diagnosed with schizophrenia, psychosis or bipolar disorder but did not 
have any active symptoms were still eligible. Participants that endorse active suicidal 
ideation or any of the above nine follow up questions regarding symptoms that could 
interfere with participation (e.g., delusional thinking) were referred to the study PI (MPJ), 
who is a licensed clinical psychologist, for a final eligibility decision (and potential 
referral to clinical resources). 
Study 2 (any type of chronic pain). The recruitment process for Study 2 isalmost 
identical to Study 1. The only difference is that instead of requiring that the participant 
have chronic low back pain, the Study 2 participants need to endorse having any type of 
chronic pain.  

Informed Consent. For both Study 1 and Study 2, participants provide verbal 
informed consent over the telephone with study staff. The UW IRB approved a waiver of 
written informed consent for this study. 
 
Statistical Analysis Plan 
Descriptive analyses of Rose use. We will compute the total number and percent 
of times sessions of each different duration were listened to (i.e., 5, 10, or 20 minutes) 
and the number of percent that each different voice were listened to across the entire 
study period for both groups. 
 Feasibility analyses. To evaluate the feasibility of Rose, and for both studies, we 
will first compute the mean, standard deviation, median and range for the number of 
times participants in the Access conditions listened to sessions as well as the number 
and percent of the participants who listened to a session at least four times during the 
first four weeks of access (i.e., per protocol). To evaluate satisfaction with use of Rose, 
we will compute the average satisfaction rating for those participants in the Access 
groups who listened to at least one session during the first four weeks of access, as well 
as the number and percent of the responses to each of the satisfaction response 
options. To evaluate interest in continued access to Rose, we will compute the average 
of the interest ratings of the participants in the Access groups who used Rose per 
protocol (i.e., at least four times during from baseline to the 4-week assessment point), 
as well as the number and percent of the responses to each of the interest question 
response options. To understand the participants' willingness to pay for continued 
access to Rose, we will compute the number and percent of responses to each of the 
payment question response options for the Access group participants in each study who 
had used Rose per protocol. Given the inherent differences between the two studies, 
Fisher’s exact tests will be used to compare satisfaction and interest for continued 
access between the two studies. To assess the usability of Rose, we will compute the 
average SUS for participants in the Access groups of each study who had used at least 
once.  
Clinical effects analyses. In order to estimate the possible effects of Rose on 
clinical outcomes, we will conduct two types of analyses. First, to estimate the 
immediate effects of the Rose sessions that target pain intensity, we will compute the 
ranges and average pre- to post-session changes in current pain intensity ratings for 
each participant individually (including participants in the Access condition who had 
access to 8 full weeks from baseline to the 8-week assessment point, and participants 
in the waitlist condition who had access for 4 weeks from the end of week 4 to the end 
of week 8 assessment point) and compute the median, minimum, and maximum of 
these values. Median statistics will be computed as the measure of central tendency 
given that the distributions of these changes were anticipated to be positively skewed 
(i.e., we anticipate that most participants would access Rose about four times during 
every 4-week period of access, but a fewer number might access Rose many times). Of 
interest is the general consistency of responses to the Rose sessions both within and 
between individuals. We will also conduct a linear mixed-effects model for the pre- to 
post-session change in pain intensity, including a random intercept for each participant 
to account for clustering (one for each study), to estimate the effect size and 

significance levels of these changes. Given the possibility that participants who found 
Rose to be particularly effective may choose to listen to more sessions than those who 
found Rose to be less effective, as a sensitivity analysis, we will assess if there is 
evidence of informed cluster sizes by testing if the effectiveness of Rose is associated 
with the number of times sessions were listened to. This allows us to determine if the 
magnitude of the pre- to post-session improvements in pain intensity and mood are 
associated with frequency of listening (i.e., if those who reported more benefits tended 
to listen more often, which could bias the estimates of average benefit).  
Next, we will calculat the mean and standard deviation for each of the five 
continuous outcomes and baseline, 4-weeks, and 8-weeks stratified by treatment 
condition (Access vs. Waitlist group). Standardized effects will be calculated to 
determine the within group change between baseline and both 4- and 8-weeks as well 
the between group difference in these changes. As this is feasibility study, no rigorous 
test of significance will be performed. However, 95% confidence intervals will be 
computed for the between group effect sizes to determine the range plausible effect 
sizes in the population.  
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