Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors' Psychological Distress
Phase: NA
Conditions: Cardiorespiratory Failure
Sponsor: Duke University

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 1 of 116 
 
Study Protocol: Optimizing a self-directed mobile coping skills 
training intervention to improve cardiorespiratory failure survivors’ 
psychological distress. 
 
Short Title: Blueprint 
 
Study Design: A Pilot, Randomized Trial 
 
Version 1.1 dated 22 July 2020 
 
 
 
 
Study Site(s): 
Duke University Hospital 
2301 Erwin Road 
Durham, NC 27710 
 
Duke Regional Hospital  
3643 N Roxboro St 
Durham, NC 27704 
 
Principal Investigator 
Christopher E. Cox, MD, MPH 
Division of Pulmonary Allergy & Critical Care 
Box 102043 
Durham, NC 27710 
Phone: 919-681-7232 
Email: christopher.cox@duke.edu 
 
Co-Investigator(s) 
Laura Porter, Ph.D. 
Behavioral Medicine 
Box 90399 
Durham, NC 27710 
Phone: 919-9416-3436 
Email: laura.porter@duke.edu 
 
Sarah Kelleher, Ph.D. 
Behavioral Medicine 
2200 W. Main St., Suite 340 
Durham, NC 27705 
Phone: 919-416-3405 
Email: sarah.kelleher@duke.edu
 
 
IRB Number: Pro00101848 
ClinicalTrials.gov identifier: NCT04329702 
 
 
 
 

  
 
 
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Table of Contents 
 
Table of Contents 
2 
Abbreviations and Definitions 
4 
Clinical Protocol Synopsis 
6 
1. 
Title 
6 
2. 
Background 
6 
3. 
Study Design 
6 
4. 
Study Objectives, Hypotheses, and Outcomes 
8 
5. 
Study Population 
8 
Eligibility Criteria: 
9 
Inclusion Criteria (at the time of hospital admission) 
9 
Exclusion Criteria (at the time of hospital admission) 
9 
Inclusion Criteria (at the time of hospital discharge; at home) 
10 
Exclusion Criteria (at the time of hospital discharge; at home) 
10 
6. 
Study Procedures 
10 
Screening, Recruitment and Consent 
10 
Study Visits 
11 
Compensation 
12 
7. 
Enrollment sites 
12 
8. 
Statistical Design, Analyses Plan, and Sample Size and Power 
13 
Statistical Design and Analyses Plan 
13 
Sample Size and Power 
13 
9. 
Subject Participation Duration 
13 
10. 
Study Duration 
13 
11. 
Risk-Benefit Assessment 
14 
Potential risks 
14 
Adequacy of protection against risks: 
14 
Protections against risk 
14 
Suicidality Response Plan 
15 
Patient Death While in Study 
16 
Patient Withdraw While in Study 
16 
Vulnerable Populations 
16 
Adverse events (AEs), serious adverse events, (SAEs) and unanticipated problems (UPs). 
16 
Period and Frequency for Event Assessment and Follow-Up 
17 

  
 
 
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Characteristics of an Adverse or Serious Adverse Event 
17 
Relationship to Study Intervention 
17 
Expectedness 
17 
Severity 
17 
Reporting Procedures 
17 
Protocol Deviations and Other Unanticipated Problem Reporting 
18 
Privacy 
18 
12. 
Data management 
19 
13. 
Data & Safety Monitoring Plan 
20 
Plans for Assurance of Compliance regarding Adverse Event Reporting. 
20 
Plans for Assuring Data Accuracy and Protocol Compliance. 
20 
Data Safety Monitoring Board (DSMB). 
20 
Quality Assurance and Confidentiality 
21 
Confidentiality 
21 
14. 
Privacy, Data Storage & Confidentiality – see Research Data Security Plan. 
21 
15. 
IRB of Record 
21 
Appendix 1: Schedule of Events 
23 
Appendix 2: Study Workflow 
24 
Appendix 3: CRFs and Surveys 
25 
Appendix 4: Assessment Tools 
109 
Appendix 5: Study Contact Information 
116 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
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Abbreviations and Definitions 
 
Adverse Event (AE) 
o Any untoward medical occurrence associated with or observed in the context of a study 
procedure. For this study and patient population, an AE will be considered any suicidal 
ideation. No other events will be considered AEs as this patient population is ill and it is 
expected that other untoward medical occurrences will occur.  
 
Clinical Trial Management System (CTMS) 
o For this study, a CTMS known as OnCore will be utilized to manage the study’s 
administrative responsibilities and subject level documentation.  
 
Duke Regional Hospital (DRH) 
o Study site in which eligible patients will be enrolled.  
 
Duke University Hospital (DUH) 
o Study site in which eligible patients will be enrolled. 
 
Electronic Data Capture (EDC) 
o For this study, the EDC will be supported by Pattern Health in which relevant study data, 
such as screening, enrollment, and clinical variables will be documented. Additionally, 
the study team will utilize RedCap, which is a secure, Duke approved EDC platform, in 
which the study screening and enrollment logs will be maintained.  
 
Electronic Health Record (EHR) 
o Used interchangeably with EMR; the EHR is the patient-specific medical record located 
in the secure MaestroCare (aka: EPIC).  
 
Electronic Medical Record (EMR) 
o Used interchangeably with EHR; the EMR is the patient-specific medical record located 
in the secure MaestroCare (aka: EPIC).  
 
Electronic Patient Reported Outcomes (ePRO) 
o ePRO can be used to describe study source, such as the patient-completed 
questionnaires (e.g., HADS, PHQ-10, PTSS), or can refer to the system that houses 
patient-derived data. For this study, ePRO may refer to the patient-questionnaires for 
psychological distress OR it may refer to the system, which houses the patient-derived 
data, which is the mCST app known as “Blueprint.”  
 
Hospital Anxiety and Depression Scale survey (HADS) 
o Anxiety and depression symptoms 
 
Intensive Care Unit (ICU) 
o Defined as any medical, surgical, trauma, neurological, cardiac, or cardio-thoracic unit in 
which a patient is receiving cardiac or respiratory support for survival means.  
 
Institutional Review Board (IRB) 
o Ethical and regulatory committee who provides approval and oversight of clinical trial at 
study site.  
 
Mobile Coping Skills Training app (mCST, also known as ‘Blueprint’) 
o A native app that uses this downloaded as a self-contained program and is subject to the 
device operating system. The mCST created for this study known as “Blueprint”, was 
developed, and is maintained by Pattern Health (212 W Main St Suite 213, Durham, NC 
27701). 
 
Patient Health Questionnaire-10 (PHQ-10) 
o Physical symptoms 
 
Post-Traumatic Stress Scale survey (PTSS) 
o PTSD symptoms 
 
 

  
 
 
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 
Protocol Deviation (PD) 
o An inadvertent event or event this is out of the control of the study team and/or the 
subject that occurs outside of the study protocol design and/or procedures.  
 
Protocol Violation 
o An act of intentionality that is committed by the study team and/or the subject that occurs 
outside of the study protocol design and/or procedures.  
 
Serious Adverse Event (SAE) 
o Defined as an adverse event that is both serious and expected in nature; the event may 
have a reasonable possibility that it is related to a study. SAEs for this study are defined 
as a suicide attempt, a hospitalization, or death. 
 
Suicide Ideation (SI) 
o The idea of committing self-harm and/or the intent to act on the idea of committing self-
harm.  
 
Unanticipated Problem (UP) 
o Any other event, not meeting the definition of PD, UP, AE or SAE that, in the opinion of 
the principal investigator, merits documentation as it occurred outside the expected 
design of the study and/or study procedures. These events, like PDs, UPs, AEs, or 
SAEs, may be reported to the IRB and/or the study sponsor, as applicable.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
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Clinical Protocol Synopsis 
 
 
1. Title  
Optimizing a self-directed mobile coping skills training intervention to improve cardiorespiratory failure 
survivors’ psychological distress (aka: Blueprint).  
 
2. Background  
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in the US, 
it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of 
psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD).  However, 
few targeted interventions exist that are relevant to patients' experiences and that accommodate their many 
physical, and social barriers to personalized care. To fill this gap, we have developed an innovative, native 
mobile coping skills training (CST) program that promotes automated care delivery and self-management 
of symptom-related distress. CST, by improving self-efficacy and adaptive coping, reduces psychological 
distress symptoms, thereby also improving quality of life. 
 
Previous trials, in which this pilot randomized clinical trial (RCT) is based, have demonstrated that adaptive 
coping skills training (CST), is an active response for managing stressful events such as the experience of 
a critical illness. Cardiorespiratory failure survivors have emphasized in their own words the importance of 
coping to their perceived quality of life. While the use of adaptive coping skills (e.g., relaxation, positive 
reframing, problem solving) is associated with decreased psychological distress, survivors infrequently 
apply such strategies. 
 
Therefore, we propose a 2-year project that will pilot CST via a native mobile app known as “Blueprint” in 
which 2 distinct aims will be operationalized and tested. Aim 1 focuses on usability prior to release for real 
patient use. For aim 1, 5 to 15 subjects will be recruited and enrolled and provide feedback on app use. 
Aim 2, which is the main focus of this project, is an RCT in which 60 eligible patients will be randomized to 
1 of 3 arms in a 3:3:2 manner (i.e., n=25: n=25: n=10). The pilot RCT is both necessary and sufficient to 
inform a future definitive RCT designed to test a longer-term, self-directed mobile app version of CST. The 
pilot will ultimately aid in addressing key gaps identified in previous trials (CSTEP and LIFT RCTs). Both 
trials previously conducted raised questions about the ideal balance between the uses of a CST therapist 
versus the use of an app to deliver content. At the conclusion of this pilot study, we hope to have 
addressed the key questions raised in previous work and use the learned information to inform the conduct 
of a next-step multi-center RCT. 
 
3. Study Design 
As mentioned in section 2, this project consists of two distinct aims: aim 1 (usability) and aim 2 (RCT). Aim 
1 of this project will be conducted within a population of 5 to 15 healthy volunteers using a single study visit 
lasting approximately 30 to 60 minutes in which they will be asked to provide feedback on the app and it’s 
contents. Individuals enrolled into this aim will be asked to provide feedback via written communication. 
Feedback will be used to improve the app for Aim 2 (RCT). 
 
Aim 2, which is the main focus of this exploratory pilot randomized clinical trial (RCT) is to be conducted 
within a population of 60 cardio-respiratory survivors with a 3-month follow-up. Eligible patients will be 
those individuals who are admitted to the hospital and receive treatment for cardio or respiratory failure. 
Additional characteristics of the target population are those that exhibit high psychological distress, as 
defined by their scoring at the time of hospital discharge via the Hospital Anxiety and Depression Scale 
(HADS) and Post Traumatic Stress Scale (PTSS) surveys. Eligible patients will be identified via daily 
electronic medical record (EMR) review and approached for consent while still hospitalized. Patients will be 

  
 
 
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asked to complete app registration and baseline survey completion post-consent, but at the time of 
hospitalization, if possible. Upon discharge, patients will be asked to complete survey 1, T1, to assess their 
levels of psychological distress. Should the patient demonstrate high enough levels of psychological 
distress, they will be randomized to 1 of 3 treatment arms:  
 
Arm 1: mCST Intervention Group 1 (self-directed coping skills training app with CST therapist intro 
call) 
 
Arm 2: mCST Intervention Group 2 (self-directed coping skills training app only) 
 
Arm 3: usual care (control group; no CST therapist and no coping skills training app) 
 
Each participant, regardless of randomization arm will be asked to complete the following surveys at the 
listed time points below: 
 
Baseline (during hospitalization, post consent) 
o Collect sociodemographic data and establish baseline psychological distress.  
 
T1 (at the time of hospital discharge, within 1 week of returning to home but no more than 1 month 
(30 days) from discharge) 
o Complete the HADS, PTSS, and PHQ-10, QOL 100-point visual analog scale, IADL/ADLs 
 
T2 (1 month (30 days) post date of discharge; up to 2 months (60 days) for completion) 
o Complete the HADS, PTSS, and PHQ-10, QOL 100-point visual analog scale, IADL/ADLs 
 
T3 (3 months (90 days) post date of discharge; up to 4 months (120 days) for completion)  
o Complete the HADS, PTSS, and PHQ-10, QOL 100-point visual analog scale, IADL/ADLs, 
CSQ-8 
 
Additionally, each participant, regardless of randomization arm, will be asked to complete a weekly HADS 
survey during the first month (30 days) of study participation, post discharge. The purpose of this survey is 
to assess overall psychological distress.  
 
For those patients who are assigned to arms 1 or 2, the will be asked to utilize the app for 1 month (28 
days). During that 1 month time period, they will be provided with weekly coping skills, as listed below:  
 
Week 1: Progressive Muscle Relaxation and Pleasant Imagery 
o Week 1 includes two coping skills: progressive muscle relaxation and pleasant imagery. 
Progressive muscle relaxation is the practice of taking time to enjoy the feeling of relaxation, 
whereas the practice of pleasant imagery is using one’s imagination to create a pleasant or 
happy see, like a pleasant daydream, that they can return to at any moment.   
 
Week 2: Pleasant Activities and activity-Rest Cycling 
o Week 2, like week 1, includes two coping skills: pleasant activities and activity rest cycling. 
Pleasant activities is intended to help one plan to do regular activities by 1) convincing one’s 
self to find time and effort to complete the activity/ies they enjoy, 2) develop a schedule to 
help them commit to completing the activity/ies, and 3) encourage one to hold themselves 
and have others help hold them accountable to complete the activity/ies. Activity rest cycling 
is a practice in which one learns to overcome “over activity”, meaning doing too much at one 
time or over doing a particular activity. There are 3 components to practicing activity rest 
cycling: 1) identify activities that one may over-do, 2) take note of how one feels after the 
activity is completed, and 3) set time limitations on how long one will perform the activity.  
 
Week 3: Fast Relax and Managing Negative Thoughts 
o Week 3 includes two coping skills: Fast relax and managing negative thoughts. The purpose 
of fast relax is to help one keep feelings, such as pain or tension levels, low throughout the 
day by allowing one’s self to be still and breath fully for a few seconds to a minute. 
Managing negative thoughts encourages individuals to understand that having negative 
thoughts is okay and normal; the practice encourages one to notice their negative thoughts, 

  
 
 
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such as worry, anger, stress, and then teaches them to take control of the thought(s) and 
then change the thought to be more positive.  
 
Week 4: Problem Solving and Maintenance 
o Week 4 includes one additional coping skill: problem solving. Problem solving is a skill that 
helps an individual focus on one problem at a time and teaches them to 1) recognize what 
the problem is, 2) understand why there is a problem, and 3) help them think about what 
they can do to solve the problem. Additionally, during week 4, individuals are instructed on 
how to maintain the coping skills learned during the previous 3 weeks and are encouraged 
to practice the skill(s) that worked best for them.  
 
At the beginning of each week, a brief introduction video explaining the study will be provided. During each 
week’s exercise, patients will have the opportunity to listen to pre-recorded visual audios of physicians and 
patients describing their own, personal coping mechanisms related to each week’s skill.  
 
The native app will track fidelity and adherence by way of automated prompts and the use of an interactive 
dashboard for administrative users (i.e., study team) to track individual patient use. Should a patient stop 
responding to the app (e.g., stop using it for any period of time), the study team may contact the patient to 
remind him/her of their commitment to the study and the importance of compliance.  
 
For those individuals in arm 3, they will receive neither therapist nor app-directed intervention. The study 
team will administer the weekly surveys during the first month (30 days) via email and/or phone, and at T1, 
T2, and T3.  
 
The study will be conducted at Duke University Hospital (DUH) and Durham Regional Hospital (DRH). 
 
4. Study Objectives, Hypotheses, and Outcomes 
The overall objective of the pilot RCT is to determine the feasibility, acceptability and clinical impact of the 
intervention on patients’ 1- and 3-month psychological distress symptoms of a self-directed mobile coping 
skills training (mCST) intervention, known as “Blueprint” as compared to usual care control.  
 
The primary hypothesis in which this study is based is that the mCST will be feasible and acceptable based 
on comparison of observed to priori benchmarks. 
 
The second hypothesis is compared to usual care, the mCST use by enrolled subjects will lead to 
improvement in symptoms of psychological distress via the HADS and PTSS at the 1- and 3-month mark 
post randomization.  
 
The primary outcome of the pilot RCT is centered on acceptability and feasibility. The Client Satisfaction 
Questionnaire 8 will measure acceptability with open-ended participant feedback completed at the time of 
T3, which is considered end of study (EOS). Feasibility will be measured by frequency of randomization, 
retention, and adherence. Secondary outcomes are HADS and PTSS scores at 1 and 3 months post-
randomization.  
 
5. Study Population 
Blueprint is centered around the RCT portion of this pilot study. As such, the primary characteristics of the 
targeted study population will be those individuals who have been admitted to a hospital environment and 
are seriously ill due to respiratory failure or insufficiency (i.e., conditions that typically require respiratory 
support such as pneumonia, acute respiratory distress syndrome [ARDS], influenza, trauma, and post-op 
complications) or cardiac failure or insufficiency (i.e., conditions that require advanced cardiac support such 

  
 
 
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as septic shock, myocardial infarction, cardiogenic shock, and congestive heart failure). Additionally, given 
the world-wide pandemic of 2020, patients who experience a hospital admission due to COVID-19 and 
require respiratory and/or cardiac support will also be enrolled.  
 
Eligibility Criteria: Patients who are deemed eligible for study participation will ultimately be those 
individuals who experience high levels of psychological distress (i.e., HADS total ≥8).  
 
Specifically, patients enrolled into this pilot, RCT will meet the following criteria:  
 
Inclusion Criteria (at the time of hospital admission) 
1. Adult patient >18 years of age.  
2. Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met. 
3. Presence of acute cardiac or respiratory failure, defined as having > 1 of the following: 
a. Mechanical ventilation via endotracheal tube for ≥4 hours 
b. Non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute 
respiratory failure (not for obstructive sleep apnea or other stable use) 
c. New supplemental oxygen requirement ≥2 liters per minute (or increase in baseline continuous 
oxygen) 
d. Use of vasopressors for shock of any etiology (ie. isoproterenol, phenylephrine, norepinephrine, 
epinephrine, dopamine, and vasopressin) 
e. Use of inotropes for shock of any etiology (ie. dobutamine and milrinone)  
f. 
Use of pulmonary vasodilators (ie. flolan, treprostinil, etc.) 
g. Use of aortic balloon pump or cardiac assist device for cardiogenic shock 
h. Use of diuretic intravenous drip (ie. lasix) 
4. Cognitive status intact, defined as: 
a. No history of significant cognitive impairment (e.g., dementia) per electronic medical records 
b. Absence of current, significant cognitive impairment (> 3 errors on the Callahan cognitive 
status screen) 
c. Decisional capacity present 
5. Absence of severe and/or persistent serious mental illness that could disrupt study participation, as 
noted in the electronic medical record (EMR) or affirmed by clinical staff at the time of screening 
and approach for consent.  
Defined as any of the following: 
a. Treatment for severe or unstable mental illness (e.g., psychosis, bipolar affective disorder, 
schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical 
record], hospitalization for any psychiatric disorder) within the 6 months preceding the 
current hospital admission 
b. No endorsement of active suicidality at time of admission or informed consent 
c. No active substance abuse at a severity that impairs ability to participate 
6.  English fluency 
 
Exclusion Criteria (at the time of hospital admission) 
1. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation 
evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen) 
2. Unable to complete study procedures as determined by staff. 
3. Lack of access to either reliable smartphone with cellular data plan or Wi-Fi. 
 

  
 
 
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Inclusion Criteria (at the time of hospital discharge; at home) 
1. Elevated baseline psychological distress symptoms, defined as HADS total score of > 8 at the 
completion of survey 1 (T1). 
 
Exclusion Criteria (at the time of hospital discharge; at home) 
1. Failure to randomize within 1 month after discharge from the hospital to home.  
2. Failure to access app within 1 month after randomization.  
  
7. Study Procedures   
Screening, Recruitment and Consent 
Screening for eligible patients will occur daily via MaestroCare by delegated study team members for 
the Aim 2 (RCT). For Aim 1 (usability), the study team will recruit healthy volunteers from the 
Pulmonary Medicine Healthy Volunteer Data Repository (Pro00102890). The study team will maintain a 
robust screening log of all individuals reviewed and will document whether or not each individual was 
eligible for the study. Additionally, they will document if each individual was approached for consent and 
the outcome of consent. It will be essential, for the future RCT that it is understood why inidivuals are or 
are not eligible for approach and/or subsequent consent, therefore the screening log will track reason 
for ineligibility and reason for non-consent.  
 
For those individuals who are eligible to consent, the study team will recruit the individual in-person or 
remotely using an approved telephone script. Patients for the RCT will be approached, ideally at the 
time of their hospital admission, just prior to their discharge to an in home setting, if possible. Should 
the study team be unable to make contact with the patient during the hospitalization, the study team will 
contact them once discharged home. However, patients can be approached earlier in their admission, if 
well enough, or within a week of returning to their home for participation in the study. All patients will be 
informed at the time of recruitment that research is voluntary and they do not have to participate if they 
do not want to. Furthermore, they will be informed that participation will not affect their care in any way. 
If a patient chooses to not participate, he/she will be documented as a ‘declined’ patient and the date of 
decline, as well as reason for decline (if available) will be documented. Should a patient be approached 
while in the hospital and opt to consent, they will be asked to complete the app registration and 
baseline survey, and then a study team member will contact them, once home, to remind them to login 
to the app to complete T1 for randomization. Should a patient be approached post-hospital discharge, 
he/she will be asked to complete app registration, baseline survey and T1 on the same day for study 
enrollment and randomization purposes. As with screening, the study team will be required to maintain 
a robust enrollment log that documents the patient’s consent status, version of informed consent with 
reference date of IRB approval, and then ultimate study status with associated visit milestones.  
 
It is important to note that for this study, there are several statuses an individual can have. They are 
listed below:  
 
Screened (in screening or screened): defined as any individual whose EMR (aim 2 only) or 
REDCap CRF (aim 1 only) has been reviewed against protocol for eligibility purposes. 
Individuals who are assigned this status must be noted on the screening log.  
 
Consented: defined as any individual who is approached for consent and voluntarily chooses to 
consent to the study, the procedures, risks and benefits with the understanding that they may 
withdraw at any time. A signed/dated informed consent must be on record to account for this 
individual. Patients, enrolled in the aim 2, who reach this status will be required to complete T1 
at the time of hospital discharge within 1 week but no more than 1 month from returning to 
home. Individuals who are assigned this status must be noted on the enrollment log. 

  
 
 
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 
Declined: defined as any individual who was approached for consent, but opted to NOT 
consent and therefore to NOT participate in the study. Individuals who are assigned this status 
must be noted on the screening log. 
 
Randomized (aim 2 only): defined as any patient who was consented to the study, is 
discharged from hospital to home, completes T1 survey, and continues to meet all eligibility 
criteria (see Eligibility Criteria, section 5). Patients who reach this status will be required to 
interact with the app on a daily basis for 1 month and then complete T2 and T3. Patients who 
are assigned this status must be maintained on the enrollment log.  
 
Screen Failed (aim 2 only): defined as any patient who was consented to the study, is 
discharged from hospital to home, and completes T1 survey, and DOES NOT meet all eligibility 
criteria (see Eligibility Criteria, section 5). Patients who reach this status have no additional 
follow-ups or study requirements. Patients who are assigned this status must be maintained on 
the enrollment log. 
 
Withdraw by PI or Self: defined as any individual who voluntarily consents to participate in the 
study, but is then withdrawn from the study. The PI may withdraw a participate at any time 
without their consent if the PI deems it is in their best interest to no longer participate OR the 
patient demonstrates continuous lack of compliance with study protocol and study procedures. 
Additionally, if the patient is re-admitted to the hospital during the time of randomization, he/she 
will be withdrawn from the study by the PI. The study team may re-enroll the patient at the time 
of discharge following the same screening procedures. The patient may withdraw themselves at 
any time; the study team will be asked to document the reason for withdraw for study records. 
Patients who reach this status have no additional follow-ups or study requirements. Patients 
who are assigned this status must be maintained on the enrollment log. 
 
Lost to Follow-Up (LTF): defined as any individual who voluntarily consents to participate in 
the study but after non-compliance and at least 3 documented, attempted contacts appropriately 
spaced 1-5 days apart, the individual will be considered LTF.  
o For aim 2 only:  
 
Patients who reach this status have no additional follow-ups or study 
requirements. Patients who are assigned this status must be maintained on the 
enrollment log. 
 
A patient who returns the study team’s contacts within 1 week of last attempted 
contact may resume study participation.  
 
Completed: defined as any individual who both consented and randomized to the study and 
completed T1-T3 (aim 2 only) or any individual who completed assigned study visit (aim 1 only). 
Individuals who reach this status have no additional follow-up or study requirements. Individuals 
who are assigned this status must be maintained on the enrollment log. 
 
Study Visits 
 
For aim 1, each participant will be asked to complete a singular study visit that last approximately 30-60 
minutes. During this study visit, post consent, the individual will be asked to do the following: 
 
Find and install the Pattern Health app 
 
Register to the Blueprint study 
 
Complete baseline survey 
 
Randomize to 1 of 3 arms or screen fail purposely  
 
Provide feedback on app content and usability.  
 
For aim 2, each consented patient will be asked to complete up to four individual study visits. 

  
 
 
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 
Baseline: this visit is to occur post-consent (same day, ideally) at the time of hospital admission 
just prior to discharge. However, this visit may occur at the time of hospital discharge within 1-3 
days of returning to home. At this visit, the following will occur: 
o App Registration 
o Baseline Survey Completion 
 
T1 (Day 0) (+30 days): this visit is to occur at the time of hospital discharge to home, ideally 
within the first week (7 days) of returning to home; however, it can occur up to 1 month (30 
days) from the time of hospital discharge to home. At this visit, the patient will complete the T1 
survey via the app, which includes the HADS, PTSS, and PHQ-10 surveys. Score dependent, 
the patient will be randomized to 1 of 3 arms: Group 1 (Blueprint app), Group 2 (Blueprint app + 
therapist), and Group 3 (control; no Blueprint app and no therapist). If the patient’s 
psychological distress score is too low; he/she will receive an automated alert via the app 
describing they are not eligible and their study participation is complete.  
 
T2 (Day 30) (+60 days): this visit is to occur post 1 month randomization for those patients who 
remain eligible to participate in the study. HADS, PTSS, and PHQ-10 surveys will be 
administered again. If the patient’s survey scores indicate high levels of distress, as defined by 
a triggered SI alert or increased distress score from T1, a delegated study team member will 
contact the patient for safety precautions. 
 
T3 (Day 90) (+30 days): this visit is to occur post 3 months randomization for those patients 
who remain eligible to participate in the study. HADS, PTSS, and PHQ-10 surveys will be 
administered again. If the patient’s survey scores indicate high levels of distress, as defined by 
a triggered SI alert or increased distress score from T1, a delegated study team member will 
contact the patient for safety precautions. At the completion of this survey and assuming no 
additional follow-up is required due to high levels of distress, the patient’s participation in the 
study is complete.  
 
Additionally, each patient who is randomized will be asked to complete: 
 
Weekly Check-In: for those patients who are eligible for randomization to either Groups 1, 2 or 
3, a weekly check-in will be completed by a delegated study team member and/or via the app 
(randomization group dependent). This weekly check in (i.e., HADS survey) will be available 
beginning day 4 of the week until day 7 of the week.  
 
Compensation 
Compensation for study participation will be provided to each patient via Greenphire. Participates in aim 1 
will receive $20 for study participation and completion of the singular study visit. Participants in aim 2 may 
receive up to a total of $60 for study completion, $20 for each survey (T1, T2 and T3) to be paid after the 
participant has completed the trial.  
 
8. Enrollment Sites 
This study will be conducted at Duke University Health (DUH) and Duke Regional Hospital (DRH).  
 
It is anticipated that between both sites, the study team will enroll approximately 2/3 of their population from 
DUH (~40 patients) and 1/3 from DRH (~20).  
 
 

  
 
 
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9. Statistical Design, Analyses Plan, and Sample Size and Power 
Statistical Design and Analyses Plan 
The primary goal of this 3-arm pilot RCT is to explore the feasibility and acceptability of mCST to inform a 
definitive future clinical trial. To do so, we will test differences between observed and a priori-defined 
benchmarks among mCST recipients using t-tests for continuous variables and chi-square tests for 
categorical variables.  
 
The secondary goal is to estimate a reasonable range of clinical effect of mCST in comparison to a usual 
care control condition. General linear models will be used to estimate mean changes and corresponding 
95% confidence intervals (CIs) in psychological distress (i.e., HADS and PTSS scores) for each treatment 
group over the 3 months of post-randomization follow-up using SAS PROC MIXED (SAS Institute, Cary 
NC). We will fit the models with an unstructured covariance matrix to better understand and represent the 
correlation between patients’ repeated measures. We will also use similar modeling strategies to explore 
how the key clinical characteristics (e.g., history of ICU delirium, illness severity, diagnosis grouping), 
objective physical characteristics (e.g., functional status), sociodemographic factors, and mechanistic 
elements (e.g. self-efficacy) described in the conceptual model are associated with changes in 
psychological distress both within and between treatment groups. While for main analyses we will pool all 
mCST participants in comparisons with usual care control, we will also perform exploratory analyses similar 
to those described above to compare all three groups as well.  
 
Sample Size and Power 
This exploratory trial is not intended to test mCST’s efficacy. While the 60-person sample size reflects the 
pragmatics of recruitment during a short enrollment period, it is large enough both to inform us about the 
potential challenges of delivering an app-based intervention in the context of post-discharge care as well as 
to provide meaningful confidence intervals for our estimates as was true for the similarly sized LIFT RCT 
(R34 AT00819).  
 
10. Subject Participation Duration 
Participating subjects in aim 1 will be asked to participate in a singular study visit lasting 30-60 minutes. 
Participating subjects in aim 2 will be asked to participate for up to a total of 3 months. Participating in this 
pilot, randomized RCT will require 1 month of daily, active participation in which the patient is practicing 
mCST daily and completing weekly check-ins. At the end of the 1 month (post T1 completion), the patient 
will be asked to complete T2 survey. Once the patient has completed the T2 survey, he/she is finished with 
active study participation for an additional 2 months at which time they will be asked to complete T3 survey. 
Patients will be given the option, between T2 and T3 completion, to continue to utilize the app and the 
mCST content; however, no weekly check-ins will be completed at this time.  
 
11. Study Duration 
For this project, Aim 1 (usability testing) is anticipated to take approximately 1-3 months to complete 
depending on rate of recruitment, user response to app usability, and required fixes to app based on user 
response.  
 
As this project is centered around Aim 2 (pilot RCT), it is anticipated that from the initiation of Aim 2, that it 
will take 15 months to complete data collection (~12 months for cumulative enrollment with 3 months to 
complete all long-term follow up). From the time period of completing follow-up, it is estimated that it will 
take an additional 1-3 months for all final analyses to be completed for all Aims.  
 
 

  
 
 
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12. Risk‐Benefit Assessment 
Potential risks 
It is possible that participating patients could experience a breach of confidentiality should their records be 
accessed unlawfully by an outside party or general, inadvertent error.  In addition, participants may 
experience mild anxiety when answering survey questions, though we have not observed this in similar 
interventions such as LIFT or CSTEP.  However, we believe that involvement in this study will present no 
significant physical, psychological, financial, legal, or other risks.   
 
Adequacy of protection against risks:  
Recruitment and informed consent procedures.   
First, the Duke Institutional Review Board (IRB) will review and approve the study protocol before study 
initiation. Informed consent (e-consent or written) will be required from all participants, including content 
experts.  Second, we will use a standardized screening and enrollment protocol that respects participant 
privacy and rights.  The study team will only approach those patients that are deemed appropriate for the 
study, which will be determined by EMR review and/or conversations with the clinical team and/or PI. The 
approach of patients will be aided by a short IRB-approved recruitment video. The study team will then ask the 
patient to read and sign the study consent form at the time of enrollment.  Potential subjects will be given as 
much time as they need to consider study participation.  For Aim 2, we will take great care to present the 
treatment group assignment possibilities (“like drawing a number out of a hat”) tactfully and with clearly stated 
equipoise in person or via phone utilizing the IRB approved telephone script, as we have done successfully in 
past clinical trials.  A copy of the consent form will be given to participant and the original maintained in a 
secure location at the study site.   
 
Protections against risk   
General oversight   
There are several ongoing mechanisms for monitoring the occurrence of adverse events.  The PI or delegated 
study team member will perform day-to-day monitoring of the study activities. Careful monitoring of all persons 
entering the study will minimize attrition and will ensure the clinical safety of these patients.  A telephone 
number for the study team facilitates this monitoring and an email address (blueprintstudy@duke.edu) 
provided to participants upon entry into the study to report concerns related to study participation.  
 
Plans to prevent coercion of patients and to ensure voluntary participation 
We will strive to create an environment free of any coercive practices for patients. We will stress that study 
involvement is voluntary and that choosing to participate or not participate will not affect their care in anyway. 
In addition, we will utilize the standardized 2-minute informational video, which has been used successfully in 
past trials describe treatment groups and ensure a similar approach across sites.   
 
Specific longitudinal participant oversight plans for severe psychological distress (including suicidal ideation) 
Given the difficult situations faced by patients, we recognize that there is a slight risk that some participants 
may become distressed completing questionnaires or viewing study materials, as mentioned above.   
 
We will take the following measures to prevent any negative reactions as well as effectively manage any 
serious distress that occurs:  
 
(1)  All of the in-person and telephone-based data collection sessions will be conducted by study team 
members who are sensitive to the issues that arise.  
 

  
 
 
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(2) Study team members will emphasize to participants that any interviews or other study interactions are 
participant-controlled.  Thus, participants will be instructed that they are in control over what they share and 
generally how long they discuss any topic that is addressed.   
 
(3)  Participants will be told that they can discontinue an interview or telephone session at any time and that 
they are free to reschedule an interview or treatment session at any time within the week.   
 
(4)  Overall, we are very sensitive to the common and pervasive nature of psychological distress among 
cardiorespiratory failure survivors and are experienced in discussing these issues with them.  There is also a 
potential risk for identifying underlying mental health issues through the mCST sessions, telephone calls, and 
survey responses.  For issues such as passive suicidal ideation or symptoms of depression, anxiety, or PTSD, 
an informational sheet will be provided with contact numbers for additional mental health services.  
Additionally, at the beginning of the program, all subjects will be informed that the training program may 
uncover unresolved and distressing thoughts or feelings; and a list of resources will be provided at that time. 
 
 
Suicidality Response Plan  
 
Should a patient indicate to a study team member, thoughts of suicidality or ideation of suicidality, the 
Suicidality Response Plan could be activated. 
 
If the participant is deemed to be at high risk based on direct interaction plus the C-SSRS item response, the 
delegated study team member will administer the C-SSRS to assess the participant to determine if they 
endorse active suicidal ideation.  The trained staff will also determine if the participant is currently being treated 
by a mental health professional.  
 
If the patient is deemed not to be actively suicidal, they will be given a list of local mental health resources as 
follows: 
 
 
Duke: Call Emergency Psychiatry at (919)-681-4410 or (919)-681-1316, available 24 hours a day, 7 
days a week. 
 
The National Suicide Prevention Lifeline - 1-800-273-TALK (8255) is a free, 24-hour hotline available to 
anyone in suicidal crisis or emotional distress. 
 
If the participant is considered actively suicidal then at least one of the following plans will be followed 
depending on the location of the participant for each of the following situations: 
 
 
Situation 1 
o If the participant is with one of the study personnel, the study personnel will notify the site PI one 
of the other PIs immediately. 
o The study personnel will either physically walk the subject to the emergency department, or call 
a Psychiatric Emergency services number relevant to the site as described above.  
 
 
Situation 2 
o If the participant is on the telephone: 
 
The study personnel will notify the site PI one of the other PIs immediately 
 
The study personnel will stay on the telephone with the subject participant. 
 
The study personnel will immediately contact 911 to initiate an on-site rescue if such 
action is clinically indicated. 

  
 
 
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o The study personnel will stay on the telephone with the subject until EMS services have 
contacted the participant. 
 
If the participant is determined to be actively suicidal and require immediate medical therapy, they will be 
withdrawn from the study. 
As described above, all concerns about participant safety will be discussed immediately with the PI - including 
concerning severe distress that does not involve suicidality.   
 
For these situations, once an “alert situation” is known, the PI will refer the participant if needed (based on a 
PI-led phone call) to local psychological resources. The study team will also make urgent and emergency 
referrals as needed based on information learned.  
 
To date based on some studies that have included over 400 participants, we have found that <5% of 
participants will require a call from the PI during some point in the study period.  Of those, none has required 
referral to acute psychiatric care after a detailed interview from the PI.  After a disposition / solution has been 
made, both the resolution (and follow up) will be documented in the ‘contact log’ section of the data system for 
reporting to the DSMB.   
 
Patient Death While in Study 
Finally, we recognize that we are working with a critically ill population that is at risk for death during follow up 
due to their underlying illness.  Before T2 and T3 data collection, the study team will review the EMR to look for 
records of death, halting all study procedures if death has occurred and noting the date. On phoning any 
participant, the study team will initiate a conversation to tactfully ascertain the patient’s vital status should a 
family member answer first.  If the patient has died, the study team will provide brief support and their 
condolences.   
 
Withdraw While in Study 
If an individual states that they wish to drop out, the study team will respect that as well. A follow-up question 
may be asked to ascertain the reason for withdraw; however, this is for documentation purposes only.  
 
Vulnerable Populations 
This project will not enroll individuals from vulnerable populations (e.g., imprisoned persons, minors). 
 
Adverse events (AEs), serious adverse events, (SAEs) and unanticipated problems (UPs).   
It is recognized that there is a slight risk that some participants may become distressed when completing self-
report measures or participating in interviews.  When necessary, participants who experience psychological 
distress related to completing questionnaires will be referred for appropriate psychiatric or psychological care.  
All participants will have access to the PI’s contact information 24 hours a day (shown in the consent form).  If 
a telephone interview is required, a trained study team member who has been trained to be sensitive to the 
nature of these issues will conduct it.   
 
It is anticipated, in this study, for AEs to be extremely rare as it is a behavioral study. However, it is possible 
that participants could become distressed in a hospital setting or post-discharge due to increased illness and/or 
limitations. As such, participants could exhibit signs of and/or experience suicidal ideations or be admitted for 
mental health symptoms. Therefore, for this study, only increased levels of distress related to completing the 
questionnaires or completing the coping skills practice and/or suicidal ideations will be considered AEs.  
 
Like, AEs, it is not anticipated that SAEs will occur. However, for this study, an SAE would be defined as a 
suicide attempt, a hospitalization (post hospitalization that initiated the patient’s eligibility for study 

  
 
 
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participation), or death. All serious adverse events will be reported within the standard timelines required to the 
IRB, study sponsor, and/or DSMB, as appropriate and when applicable.  
 
Given the nature of this study, it is anticipated that most enrolled patients will not complete their study 
visits within the assigned protocol window. Additionally, it is expected that visits and/or mCST practices 
will be missed. As such, these will not be considered protocol deviations. Should other protocol 
deviations or unanticipated problems occur, they will be discussed with the PI, documented, and 
reported to the IRB, study sponsor, and/or DSMB, as appropriate and when applicable.  
 
Period and Frequency for Event Assessment and Follow‐Up 
Protocol deviations and other unanticipated problems, as well as AEs and SAEs, will be recorded in the 
data collection system throughout the study and reported, as appropriate, to the IRB, study sponsor, 
and/or DSMB, when applicable.  
 
The study team will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation.  At each study visit, the study team will inquire by way of verbal or written request and/or 
EMR review, of the occurrence of AE/SAEs since the last visit.  Events will be followed for outcome 
information until resolution or stabilization. 
 
Characteristics of an Adverse or Serious Adverse Event 
 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset. 
b. An alternate etiology has been established. 
 
Expectedness  
The Study PI will be responsible for determining whether an event is expected or unexpected.  An 
event will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the intervention.   
 
Severity 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks medical attention, 
needs major assistance with ADL 
 
Reporting Procedures 
 
Adverse and Serious Adverse Events 

  
 
 
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For symptoms that are either great in total burden (i.e., total score is high), a delegated study team 
member (e.g., therapist) will call the participant to check in.  For specific symptoms such as the suicidal 
ideation, a delegated study team member will also call the participant and assess the severity of the 
situation, triaging them as appropriate to psychiatric support.   
 
For other matters, the study team will maintain frequent telephone contact with most participants, and 
can refer those with concerning symptoms.   
All deaths will be reported to NHLBI Program Officer and to the DSMB Chair within 72 hours of 
study’s knowledge of death. For each patient who dies, a brief report containing the following variables 
will be provided: 
 
Age 
 
Principal diagnosis 
 
Number of comorbidities 
 
Admission APACHE II score 
 
Days since enrollment 
 
Brief description of circumstances surrounding death including expected or unexpected. 
 
Serious (fatal or life-threatening) SAEs that are unanticipated and that are related to the intervention will 
be reported to the NHLBI Program Officer and to the DSMB Chair within 7 days of study staff’s 
knowledge of the SAE.   
 
The summary of all other SAEs will be reported to NHLBI Program Officer and to the DSMB quarterly, 
unless otherwise requested by the DSMB.   
 
Protocol Deviations and Other Unanticipated Problem Reporting  
Incidents or events that meet the reporting criteria, as outlined by the Duke IRB, will be reported to the 
Duke IRB as needed.  
 
The following will be included, at a minimum:  
 
A detailed description of the event, incident, experience, or outcome;  
 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the unanticipated problem. 
 
Privacy 
The study team will closely safeguard participant privacy regarding protected health and personal information.  
A study ID number will be generated at the time of consent and will be maintained in a secure file (e.g., linker 
file) which will contain the patient name and medical record number.  Further, names, birthdates, telephone 
numbers, addresses, and medical record numbers will be stored securely as described in the RDSP and only 
accessible by delegated study team members. The RedCAP system will store all data on a secure Duke 
University server with a sophisticated dual backup system.  Study participants cannot view data via the ePRO 
system or the electronic data capture (EDC) system, supported by Pattern Health. Patients will only have 
access to the ePRO system and will access the one-way view ePRO system via secure, PHI-free email or text 
links sent from the app.  
 
Digital security 
The study digital infrastructure consists of a mobile (i.e., native) app with a built-in electronic patient reported 
outcomes (ePRO) function, an electronic data capture (EDC) system, and a separate RedCAP digital study 
database. 

  
 
 
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 
mCST app:  The mCST app will be a native app. The programming service providers, Pattern Health, 
endeavor to build technological solutions that preserve the privacy, confidentiality, and security of 
protected health information that may be part of health records or research datasets. Protected Health 
Information (PHI) is handled according to appropriate Health Insurance Portability and Accountability 
Act of 1996 (HIPAA) Privacy and Security Regulations.  All staff who work with sensitive data are 
required to complete appropriate HIPAA training with periodic updates, complete human subjects and 
data privacy training, comply with site IT Security Policies, and agree to the provisions of the University 
Rules of Behavior and Sanction Policy.  All sites strive to implement reasonable security controls in its 
product builds guided by FISMA, HIPAA, and OMB Circular A-130, Appendix III. Pattern Health has 
implemented and maintains several security protocols and controls for apps as well.  Pattern Health 
has developed a formal information security program, with a named individual responsible for its overall 
execution.  Pattern Health also periodically conducts an information technology (IT) security risk 
assessment on its projects, maintains formal documented protocols for reporting security breaches, 
assesses and manages security risks associated with vendors and subcontractors, maintains employee 
on-boarding and off-boarding policies that protect study data and integrity, and ensures continuing 
employee awareness of and education on security policies, standards, and procedures.  In terms of 
development approaches to security, Pattern Health evaluates and installs security patches in a timely 
fashion, protects systems against self-propagating malware, maintains secure coding policies and 
practices, and utilizes standardized secure build processes to protect Pattern Health hardware that 
accesses customer networks, protecting confidential data against attack.  All storage of confidential 
participant data on Pattern Health hardware is strictly prohibited, and the use of off-shore service 
providers and/or data center facilities is prohibited unless approved by client.  For our study, the native 
app application and supporting backend system that Pattern Health develops will be hosted securely 
per DHTS regulations. 
 
EDC: The EDC has been developed and is supported by programming service providers, Pattern 
Health. As noted above, Pattern Health maintains all appropriate PHI and HIPAA regulations related to 
human subject research and data privacy and integrity pertaining to data management and IT security. 
The EDC will be a central location in which all study related data abstracted from each enrolled 
patient’s EMR will be stored. Data will be exported and analyzed for research purposes.  
 
REDCap:  The project will utilize a REDCap database system customized for our data needs.  For data 
validation, a series of project-defined data checks and conditional constraints can be required to ensure 
the highest quality data collection.  All system login procedures and data submissions will be 
transported and encrypted via the Transport Layer Security (TLS) protocol to the secure central 
database at Duke University.  The study team will use login/password (reset every 6 months) 
credentialing for authentication of all study staff.  User-level permissions will be based on user roles 
and defined within the project system to limit a user’s access to only those records an individual is 
authorized to see. Duke Health Technology Solutions staff to verify that security measures are 
operational will review audit logs routinely.  The servers are scanned twice weekly for vulnerabilities 
and are currently maintained at the highest level of vendor and CERT security recommendations.  Data 
will never be shared outside the project unless authorized by the project leader and the Duke IRB.  
User authentication is based on user passwords as described earlier.  Password creation requirements 
are in place to guarantee “strong passwords” as defined by the CERT security recommendations.  The 
lead systems administrator is GIAC Security Essentials certified through May 2018. 
 
13. Data management 
Most data entry will be self-completed by participants using the validated ePRO system accessed via the 
mCST app. The study team will complete electronic case report forms (eCRFs) securely integrated within 
the EDC by abstracting relevant clinical data from each patient’s EMR.  RedCap will be utilized to maintain 
study screening and enrollment logs. The mCST app dashboard, developed by Pattern Health for 

  
 
 
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administrative use only, will be accessed and used by delegated study team members to create scheduled 
reports on the trials’ conduct (e.g., study milestones) to enhance the study's quality.  Through this 
dashboard, quality and consistency of data, will be monitored. The Project Manager will do routine data 
cleaning and statistical team using customized group-blinded reports that will identify missing, outlier, or 
nonsensical data at time points when remedying them is feasible. 
 
14. Data & Safety Monitoring Plan 
Plans for Assurance of Compliance regarding Adverse Event Reporting.   
The study team will be required to document and report adverse events (including serious adverse events) to 
the Institutional Review Board (IRB), as appropriate and in line with institutional reporting criteria. In addition, 
all adverse events are reported as part of NIH Progress Reports in the non-competitive and competitive 
renewals.   
 
Plans for Assuring Data Accuracy and Protocol Compliance. 
The PI will supervise the study, including data management, data accuracy, and protocol compliance.  The 
study biostatistician and Project Manager will be the chief data managers and will adhere to established federal 
and institutional patient safety and protection guidelines.  To assure data accuracy, the Project Manager will 
review data system reports on a routine basis.  These reports will show enrollment, missing data, and other 
values that are neither study ID- nor outcome-based.  The Project Manager will process detailed reports to 
search for errors and generate basic reports for dissemination for regular staff meetings.   
 
Data Safety Monitoring Board (DSMB).  
Aim 2's RCT trial will be supervised by a single independent DSMB composed of professionals with significant 
experience in clinical trials, mind and body interventions, epidemiology, and biostatistics who are not directly 
involved in the study, its interpretation, or any study institution and have no active research relationship with a 
study team member.   
 
The main responsibilities of the DSMB will be to (a) assess for the presence of potential harms and unintended 
consequences of the mCST intervention, (b) ensure the validity and integrity of the data, and (c) make 
recommendations to the investigators and to the NIH about whether the study should be continued without 
modification, continued with modification, or terminated.  
 
The initial DSMB meeting will occur before the initiation of subject enrollment for the purpose of updating 
members on the study, ensuring agreement on the review process, establishing the review methodology and 
procedures, ensuring all conflicts of interest are disclosed (to be reviewed by NHLBI staff), reviewing the 
protocol, and codifying a written charter.  The NHLBI's Data Safety Monitoring Plan (DSMP) Template will be 
used to guide the drafting of the charter.  This document will specify procedures for protocol amendments, 
ensuring participant confidentiality and privacy, ensuring database protection, coordinating center 
responsibilities, creating adverse outcome definitions (adverse events, unanticipated problems, and serious 
adverse events), protocol for reporting and responding to adverse events while also maintaining subject 
confidentiality, justifying sample size, assessing accrual and compliance, halting and stopping rules (drafted 
with the assistance of the DSMB chair and the DSMB lead statistician), approving informed consent 
documents, and guidelines for quality control and quality assurance.  Before enrollment begins, the DSMB 
charter will be approved by both the DSMB and the NHLBI; additionally, ClinicalTrials.gov registration will be 
finalized as per the Milestone Plan shown in the Research Strategy document. 
 
The first DSMB data review will occur either after the first 20 participants have been enrolled or enrollment has 
occurred for 6 months, whichever is observed first.  Thereafter, the DSMB will review cleaned data reports 
(provided by the Project Manager 2 weeks before the DSMB meeting) every 3 months during enrollment and 

  
 
 
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follow up, and will prepare a report with any recommendations within 2 weeks following their review.  The 
specific study metrics that the DSMB will review at each meeting include enrollment rate, dropout rate, HADS 
scores, PTSS scores, and Adverse Events.  The primary safety measures will be Adverse Events reports and 
HADS scores.   
 
Other items reviewed by the DSMB at each meeting will include: (a) data quality, completeness, and 
timeliness; (b) performance of the individual sites; (c) adequacy of compliance with goals for recruitment and 
retention, including women and minorities; (d) protocol adherence; and (e) presence of factors that could 
adversely affect study outcome or compromise data confidentiality.  Study participants will be recovering from 
life-threatening illnesses managed in intensive care units, which increase the likelihood of death overtime in 
comparison to healthy individuals.  As such, any patient deaths and their cause during the follow up period will 
be recorded, discussed, and highly scrutinized.   
 
The study biostatistician will oversee any DSMB statistical requests and interpretations.  During the review 
process, formal statistical tests may be performed under DSMB supervision if requested (e.g., examining the 
differences in Adverse Event or outcome rates between factor-based groups).  Additionally, the DSMB may 
request a formal statistical assessment if a suspicious increase in HADS score is observed in any factor-based 
group.  If a specific factor group is found to have a statistically significant increase in HADS score, the DSMB 
scope of action may include recommendation for stopping the trial.  For differences in study dropout rates, 
appropriate changes to the protocol will be made by PI consensus after DSMB member input.  Any protocol 
changes, as well as any adverse events, will also be immediately reported to the relevant site IRB, the Central 
Institutional Review Board (located at Duke University), as well as to the NHLBI Program Officer. 
 
Quality Assurance and Confidentiality 
First, the electronic data entry system “forces” responses to key questionnaire items (e.g., primary outcomes 
surveys) before allowing progression through the particular interview’s template, thereby minimizing missing 
data.  For less critical items, delayed data entry is possible (though these data elements are non-essential to 
primary aims analyses). However, each time the study team logs into the secure data entry system, prompts 
appear on the welcome screen that show what data elements remain incomplete (as well as the time frame 
within which they must be entered) for all site participants.   
 
The study PI will ensure the validity of the data system by examining electronic summary case report forms 
within the EDC system to ensure adequacy and accuracy of data collection as well as transcription to the 
database itself after enrollment of the first 5 participants.  Agreement will be reviewed and discrepancies will be 
discussed.   
 
Confidentiality  
Subjects will not be identified on any study reports.  University firewalls, multiple passwords, and encryption 
programs protect the security of the electronic data entry system, which will be housed on a highly secure 
Duke University server.  All personal computers are located in lockable offices and are accessible only by 
frequently changed passwords.  The server room is accessible only to designated University Systems 
Administrators.   
 
15. Privacy, Data Storage & Confidentiality – see Research Data Security Plan.  
 
16. IRB of Record  
Duke University Health System (DUHS) IRB will be utilized as the IRB of record for this project pilot 
randomized, RCT and the future RCT.  
 

  
 
 
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A copy of the most recent DUHS IRB Federal Wide Assurance (FWA) statement may be found at: 
https://irb.duhs.duke.edu/about-us/federal-wide-assurance 
 
DUHS IRB current and historical rosters may be found at: https://irb.duhs.duke.edu/irb-review-
process/rosters 
 
DUHS IRB meeting dates may be found at: https://irb.duhs.duke.edu/irb-review-process/irb-meetings 
 
 

  
 
 
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Appendix 1: Schedule of Events  
 
 
Day 0 (In-Hospital, 
Baseline) 
Day 1 , T1 
(Discharge) (+30 
days) 
Week 1 
Week 2 
Week 3 
Week 4 
Day 30, T2 (+60 
days) 
 
Day 90 (+30 days), 
T3 
Screening* 
X 
 
 
 
 
 
 
Consent (a)* 
X 
 
 
 
 
 
 
App Registration* 
X 
 
 
 
 
 
 
Baseline Survey (b)* 
X 
 
 
 
 
 
 
Usability Survey* 
 
 
 
 
 
 
 
T1 Survey (c) 
 
X 
 
 
 
 
 
T2 Survey (c) 
 
 
 
 
 
X 
 
T3 Survey (c) 
 
 
 
 
 
 
X 
Weekly Check-In (d) 
 
 
X 
X 
X 
 
 
Progressive Muscle Relaxation and 
Pleasant Imagery (mCST) 
 
 
X 
 
 
 
 
Pleasant Activities and Activity 
Rest Cycling 
 
 
 
X 
 
 
 
Fast Relax and Managing Negative 
Thoughts 
 
 
 
 
X 
 
 
Problem Solving and Maintenance 
 
 
 
 
 
X 
 
Data Entry (e) 
X 
X 
 
 
 
X 
X 
AE/SAE assessment (f) 
X 
X 
 
 
 
X 
X 
Survival Status (f) 
 
X 
 
 
 
X 
X 
End of Study (g) 
 
 
 
 
 
 
X 
 
a) 
Patients may be approached and consented during their admission, if well enough; their hospitalization (e.g., while in step-down), or within 1-3 days of returning to their home for 
participation in the study 
b) 
Completion of the baseline survey includes the patient providing self-reported information such as social and demographic information and general health status.  
c) 
Surveys 1, 2 and 3 will be completed via the app by all study participants, regardless of arm assignments. Patients who are assigned to the control arm will be alerted when it is 
time to complete their T2 and T3 via app notification.  
d) 
For those participants assigned to Arm 1 or 2, they will complete a weekly check-in to ascertain overall safety of the patient and usefulness of coping skills practice.  
e) 
AE/SAE assessment and survival status will be completed via EMR review and/or telephone interview.  
f) 
Study completion for patients enrolled in the study is considered to occur at the completion of T3. However, participants may undergo EOS if they are withdrawn from the study by 
the PI or opt to withdraw from the study voluntarily at any time. Should withdraw of a patient occur, the reason for withdraw and date of withdraw will be documented. AE/SAEs 
and survival status will be noted, as applicable.   
*For aim 1 only.  
 
 

  
 
 
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Appendix 2: Study Workflow 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Daily Screening of EMR for 
Eligible Patients 
Ineligible 
(document 
on screening 
log) 
Note: approach may occur 
while patient is still hospitalized 
or within 1-3 days of discharge.  
Eligible  
(document on 
screening log and 
approach for 
consent) 
Consent  
(document on 
enrollment log) 
Declined 
(document 
on screening 
log) 
App Registration & 
Baseline Survey 
Completion 
Note: Complete data entry in 
RedCap and EDC, as well as 
CTMS (OnCore) 
T1 Survey Completion 
(+30 days from discharge) 
Note: T1 is completed once the 
patient is discharged from the 
hospital. Patients will be 
randomized to 1 of 3 arms or 
screen failed.  
Screen Failed 
(HADS < 8), EOS 
Randomized: Arm 
1 or Arm 2 
(intervention) 
Randomized: Arm 
3 (control) 
4 weeks of mCST 
with 3 weekly 
check-ins 
T2 Completion (Day 
30, + 60 days) 
T3 Completion (Day 
90, + 30 days) 
T2 Completion (Day 
30, + 60 days) 
T3 Completion (Day 
90, + 30 days) 
Note: 
Complete 
data entry in 
RedCap 
and EDC, 
as well as 
CTMS 
(OnCore) 

  
 
 
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Appendix 3: CRFs and Surveys 
 
A. Hospital Anxiety and Depression Scale (HADS) 
B. Patient Health Questionnaire – 10 (PHQ‐10) 
C. Post‐Traumatic Stress Scale (PTSS) 
D. QOL‐100 Visual Analog Scale 
E. Instrumental Activities of Daily Living/Activities of Daily Living (IADL/ADL) 
F. Baseline Survey 
1. Please begin by telling us a little more about yourself.  
 
(This is an information screen that requires no response) 
 
This survey should take approximately 10 minutes to complete. Click Next to continue.  
 
 2. Where were you enrolled in the study? 
 
Ask your Clinical Research Coordinator if you are unsure 
 
Response is **one** of: 
 
 - Medical ICU 
 - Surgical ICU 
 - Cardiac ICU 
 - Neurological ICU 
 - Other 
 - Not Applicable 
 
 3. What is your home address?  
 
Street Address City, State and Zip Code 
 
Response is **free-form text**, at least 20 characters. 
 
 4. What is your home phone? 
 
(111)111-1111 
 
Response is **free-form text**, at least 10 characters. 
 
 5. Is there another phone we could use to contact you?  
 
This question is optional. 
 
(111)111-1111 
 
Response is **free-form text**, at least 10 characters. 
 
 6. How do you prefer to be contacted?  

  
 
 
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Response is **one** of: 
 
 - Email  
 - Text message 
 - Cell phone call  
 - Home phone call 
 
 7. What is the best time to contact you?  
 
Response is **one** of: 
 
 - 6 am - 8 am 
 - 9 am - 11 am  
 - 12 pm - 2 pm 
 - 3 pm - 5 pm 
 - 6 pm - 8 pm 
 
 8. Do you consider yourself Hispanic or Latino? 
 
Response is **one** of: 
 
 - Yes 
 - No 
 - Don’t know or don’t want to answer 
 
 9. Which racial group do you most identify with? 
 
Select only one. 
 
Response is **one** of: 
 
 - American Indian or Alaska Native 
 - Asian 
 - Black or African American 
 - Native Hawaiian or Other Pacific Islander 
 - White 
 - Other 
 - l identify with 2 or more groups equally 
 
 10. Select all racial groups that you identify with: 
 
Please select all that apply. 
 
Response is **one or more** of: 
 
 - American Indian or Alaska Native 
 - Asian 
 - Black or African American 
 - Native Hawaiian or Other Pacific Islander 

  
 
 
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 - White 
 - Other 
 
 11. If other, please specify: 
 
Please select all that apply. 
 
Response is **free-form text**. 
 
 12. What is your current marital status? 
 
Response is **one** of: 
 
 - Married or live with partner 
 - Separated 
 - Divorced 
 - Widowed 
 - Single 
 
 13. Do you have someone who can help to take care of you? 
 
Response is **Yes** or **No**. 
 
 14. What is that person’s relationship to you? 
 
Response is **one** of: 
 
 - Spouse or partner 
 - Child 
 - Parent 
 - Brother or sister 
 - Other family 
 - Friend 
 - Other 
 
 15. If other, please specify:  
 
Response is **free-form text**. 
 
 16. Do you live with this person? 
 
Response is **Yes** or **No**. 
 
 17. Do children 18 or under live at home with you? 
 
Response is **Yes** or **No**. 
 
 18. Thinking back to the month or so before hospitalization, what best describes your work situation: 
 
This question is optional. 

  
 
 
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Response is **one** of: 
 
 - Working full time 
 - Working part time 
 - Homemaker full time 
 - Unemployed, looking for work 
 - Retired 
 - Disabled 
 - Student 
 
 19. What was the highest grade you completed in school? 
 
This question is optional. 
 
Response is **one** of: 
 
 - Less than high school graduate 
 - High school graduate or equivalent (GED) 
 - Trade, technical, or vocational school 
 - Some college but no degree 
 - College degree 
 - Postgraduate work or degree 
 
 20. How often do you have a drink containing alcohol?  
 
This question is optional. 
 
Response is **one** of: 
 
 - Never 
 - Monthly or less 
 - 2 to 4 times a month 
 - 2 to 3 times a week 
 - 4 or more times a week  
 
 21. Do you currently practice meditation or mindfulness? 
 
This question is optional. 
 
Response is **Yes** or **No**. 
 
 22. Would you like to be sent a brief overview of the study findings at the conclusion of the study? 
 
This question is optional. 
 
Response is **Yes** or **No**. 
 
  
 

  
 
 
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 23. Please answer these questions by thinking back to the month or so before you were admitted to 
the hospital. 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 24. I am able to adapt when changes occur. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 25. I can deal with whatever comes my way. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 26. I try to see the humorous side of things when I am faced with problems. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 27. Having to cope with stress can make me stronger. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 

  
 
 
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 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 28. I tend to bounce back after illness, injury, or other hardships. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 29. I believe I can achieve my goals, even if there are obstacles. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 30. Under pressure, I stay focused and think clearly. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 31. I am not easily discouraged by failure. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 

  
 
 
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 - Often true 
 - True nearly all the time 
 
 32. I think of myself as a strong person when dealing with life's challenges and difficulties. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 33. I am able to handle unpleasant or painful feelings like sadness, fear, and anger. 
 
This question is optional. 
 
Response is **one** of: 
 
 - Not true at all 
 - Rarely true 
 - Sometimes true 
 - Often true 
 - True nearly all the time 
 
 34. Click Next to submit your answers. 
 
(This is a score screen that requires no response) 
 
You're almost done! 
 
 35. Thank You! 
 
(This is an information screen that requires no response) 
 
Please click Next to exit the survey. 
 
 
G. T1 Survey 
 
# T1 
 
 First Survey 
 
 1. During the past 3 months, have you been treated for depression, anxiety, PTSD, or any other 
psychiatric condition? 
 
Response is **Yes** or **No**. 

  
 
 
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 2. In the past 3 months, have you been treated for depression or depressed mood? 
 
Response is **Yes** or **No**. 
 
 3. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 4. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 5. In the past 3 months, have you been treated for anxiety? 
 
Response is **Yes** or **No**. 
 
 6. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 7. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 8. In the past 3 months, have you been treated for post-traumatic stress disorder (PTSD)? 
 
Response is **Yes** or **No**. 
 
 9. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 10. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 11. In the past 3 months, have you been treated for chronic pain? 
 
Response is **Yes** or **No**. 
 
 12. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 13. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 14. For the next questions, select the option that best fits your current situation 

  
 
 
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(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 15. I have someone to confide in or talk to about myself and my problems. 
 
Response is **one** of: 
 
 - Never 
 - Rarely 
 - Sometimes 
 - Usually 
 - Always 
 
 16. At the end of an average month, what describes how you usually feel when you are paying the 
bills? 
 
Response is **one** of: 
 
 - Short on money and need more to pay bills 
 - Barely have enough to pay bills and for basic needs 
 - Have enough for just a few extra things 
 - Completely comfortable 
 
 17. Please select the response that describes how you felt in the past week. 
 
(This is an information screen that requires no response) 
 
Click Next to continue 
 
 18. I feel tense or wound up 
 
Response is **one** of: 
 
 - Most of the time 
 - A lot of the time  
 - Time to time, occasionally  
 - Not at all 
 
 19. I still enjoy the things I used to enjoy 
 
Response is **one** of: 
 
 - Hardly at all 
 - Only a little 
 - Not quite so much 
 - Definitely as much 
 
 20. I get a frightened feeling like something awful is about to happen 

  
 
 
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Response is **one** of: 
 
 - Very definitely and quite badly 
 - Yes, but not too badly 
 - A little, but it doesn’t worry me 
 - Not at all 
 
 21. I can laugh and see the funny side of things 
 
Response is **one** of: 
 
 - Not at all 
 - Definitely not so much now 
 - Not quite so much now 
 - As much as I always could 
 
 22. Worrying thoughts go through my mind 
 
Response is **one** of: 
 
 - A great deal of the time 
 - A lot of the time 
 - From time to time but not too often 
 - Only occasionally 
 
 23. I feel cheerful 
 
Response is **one** of: 
 
 - Not at all 
 - Not often 
 - Sometimes 
 - Most of the time 
 
 24. I can sit at ease and feel relaxed 
 
Response is **one** of: 
 
 - Not at all 
 - Not often 
 - Usually 
 - Definitely 
 
 25. I feel as if I am slowed down 
 
Response is **one** of: 
 
 - Nearly all of the time 
 - Very often 

  
 
 
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 - Sometimes 
 - Not at all 
 
 26. I get a sort of frightened feeling like butterflies in the stomach 
 
Response is **one** of: 
 
 - Very often 
 - Quite often 
 - Occasionally 
 - Not at all 
 
 27. I have lost interest in my appearance 
 
Response is **one** of: 
 
 - Definitely 
 - I don’t take as much care as I should  
 - I may not take quite as much care 
 - I take just as much care as ever 
 
 28. I feel restless as if I have to be on the move 
 
Response is **one** of: 
 
 - Very much indeed 
 - Quite a lot 
 - Not very much 
 - Not at all 
 
 29. I look forward with enjoyment to things 
 
Response is **one** of: 
 
 - Hardly at all 
 - Definitely less than I used to 
 - A bit less than I used to 
 - As much as I ever did 
 
 30. I get sudden feelings of panic 
 
Response is **one** of: 
 
 - Very often indeed 
 - Quite often 
 - Not very often 
 - Not at all 
 
 31. I can enjoy a good book or radio or TV program 
 

  
 
 
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Response is **one** of: 
 
 - Very seldom 
 - Not often 
 - Sometimes 
 - Often 
 
 32. Over the last week or so, how often have you been bothered by the following problems? 
 
(This is an information screen that requires no response) 
 
Click Next to continue.  
 
 33. Feeling nervous, anxious or on edge 
 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 34. Not being able to stop or control worrying 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 35. Worrying too much about different things 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 36. Trouble relaxing 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 37. Being so restless that it is hard to sit still 

  
 
 
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Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 38. Becoming easily annoyed or irritable 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 39. Feeling afraid as if something awful might happen 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 40. The last few questions asked how often you were bothered by the problems. Now, please share 
how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No Distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious Distress) 
 
 41. In the last week or so, how often have you experienced the following. 
 
(This is an information screen that requires no response) 
 
Click Next to continue.  
 
 42. I had sleep problems. 

  
 
 
Protocol version: 1.1  
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Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 43. I had nightmares. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 44. I had depression or felt dejected / downtrodden. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 45. I had jumpiness- I am easily frightened by sudden sounds or movements. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 46. I had the need to withdraw from others. 
 
Response is **one position** in this scale: 

  
 
 
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 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 47. I had irritability - I was easily agitated, annoyed and angered. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 48. I had frequent mood swings. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 49. I had a bad conscience, blamed myself, or had guilty feelings. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 50. I had a fear of places or situations that reminded me of the Intensive Care Unit. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 

  
 
 
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 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 51. I had muscular tension. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 52. The last few questions asked how often you were bothered by the problems. Now, please share 
how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No Distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious Distress) 
 
 53. Over the last 2 weeks, how much have you been bothered by any of the following problems? 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 54. Pain 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 

  
 
 
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 55. Difficulty concentrating 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 56. Weakness 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 57. Feeling your heart pound or race 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 58. Shortness of breath (or other breathing problems) 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 59. Stiffness in joints or muscles 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 60. Constipation or diarrhea 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 61. Nausea, gas or indigestion 
 

  
 
 
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Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 62. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No Distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious Distress) 
 
 63. In general, how would you rate your current quality of life? 
 
Response is **one position** in this scale: 
 
 - 0 (Worst imaginable quality of life) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Best imaginable quality of life) 
 
 
 78. How much do you agree or disagree with each statement?  
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 79. I never give up. 
 
Response is **one** of: 
 

  
 
 
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 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 80. I do everything to get well. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 81. I keep fighting to get better. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 82. I am afraid of pain. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 83. I can hardly tolerate pain. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 84. I am tough to myself when in pain. 
 
Response is **one** of: 
 

  
 
 
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 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 85. I view my illness as a personal learning experience. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 86. I am able to turn my illness into something positive. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 87. I use my illness in a creative way.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 88. I am gloomy about recovery.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 89. I feel the future is bleak. 
 
Response is **one** of: 
 

  
 
 
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 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 90. I do not believe in a happy ending.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 91. I resign myself to my destiny.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 92. I reconcile myself to the inevitable.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 93. I accept whatever will happen. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 94. Please indicate how frequently or infrequently you’ve been having each experience over the past 3 
days, including today. 
 
(This is an information screen that requires no response) 

  
 
 
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Click Next to continue. 
 
 95. I’m finding it difficult to stay focused on what’s happening in the present. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost Never 
 
 96. I’m rushing through activities without being really attentive to them. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 97. I’m doing jobs or tasks automatically, without being aware of what I'm doing. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 98. I’m finding myself preoccupied with the future or the past. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 99. I’m finding myself doing things without paying attention. 
 
Response is **one** of: 

  
 
 
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 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 100. Click Next to submit your answers and see your results. 
 
(This is a score screen that requires no response) 
 
 101. Thank you. 
 
(This is an information screen that requires no response) 
 
After reviewing your results you were found to have a low needs score, and this is a good thing! You 
are not required to complete any other surveys or exercises. Your participation has been completed as 
of today.  
 
CLICK NEXT TO SAVE YOUR RESULT 
 
 102. Thank you! 
 
(This is an information screen that requires no response) 
 
Congratulations! You are now enrolled in the Blueprint program. You will find new tasks added to your 
home screen daily. 
 
You can then review your daily tip and complete your coping skills practice. 
 
CLICK NEXT TO SAVE YOUR RESULT 
 
 
H. T2 Survey 
 
# T2 
 
 Second Survey 
 
 1. In the past month, have you been treated for depression, anxiety, PTSD, or any other psychiatric 
condition? 
 
Response is **Yes** or **No**. 
 
 2. In the past month, have you been treated for depression or depressed mood? 
 
Response is **Yes** or **No**. 
 
 3. Were you treated with medication? 

  
 
 
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Response is **Yes** or **No**. 
 
 4. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 5. In the past month, have you been treated for anxiety? 
 
Response is **Yes** or **No**. 
 
 6. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 7. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 8. In the past month, have you been treated for post-traumatic stress disorder (PTSD)? 
 
Response is **Yes** or **No**. 
 
 9. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 10. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 11. In the past month, have you been treated for chronic pain? 
 
Response is **Yes** or **No**. 
 
 12. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 13. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 14. Since you were last discharged from the hospital, have you been admitted to the hospital again?   
 
Response is **Yes** or **No**. 
 
 15. How many times have you been admitted? 
 
Response is **one** of: 

  
 
 
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 - Once 
 - 2 times 
 - 3 or more times  
 
 16. For the next questions, select the option that best fits your current situation. 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 17. I have someone to confide in or talk to about myself and my problems. 
 
Response is **one** of: 
 
 - Never 
 - Rarely 
 - Sometimes 
 - Usually 
 - Always 
 
 18. At the end of an average month, what describes how you usually feel when you are paying the 
bills? 
 
Response is **one** of: 
 
 - Short on money and need more to pay bills 
 - Barely have enough to pay bills and for basic needs 
 - Have enough for just a few extra things 
 - Completely comfortable 
 
 19. Please select the response that describes how you felt in the past week. 
 
(This is an information screen that requires no response) 
 
Click Next to continue 
 
 20. I feel tense or wound up 
 
Response is **one** of: 
 
 - Not at all  
 - Time to time, occasionally 
 - A lot of the time 
 - Most of the time 
 
 21. I still enjoy the things I used to enjoy 
 
Response is **one** of: 
 

  
 
 
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 - Definitely as much  
 - Not quite so much 
 - Only a little 
 - Hardly at all 
 
 22. I get a frightened feeling like something awful is about to happen 
 
Response is **one** of: 
 
 - Not at all 
 - A little, but it doesn’t worry me 
 - Yes, but not too badly 
 - Very definitely and quite badly 
 
 23. I can laugh and see the funny side of things 
 
Response is **one** of: 
 
 - As much as I always could 
 - Not quite so much now 
 - Definitely not so much now 
 - Not at all 
 
 24. Worrying thoughts go through my mind 
 
Response is **one** of: 
 
 - Only occasionally 
 - From time to time but not too often 
 - A lot of the time 
 - A great deal of the time 
 
 25. I feel cheerful 
 
Response is **one** of: 
 
 - Most of the time 
 - Sometimes 
 - Not often 
 - Not at all 
 
 26. I can sit at ease and feel relaxed 
 
Response is **one** of: 
 
 - Definitely 
 - Usually 
 - Not often 
 - Not at all 
 

  
 
 
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 27. I feel as if I am slowed down 
 
Response is **one** of: 
 
 - Not at all 
 - Sometimes 
 - Very often 
 - Nearly all of the time 
 
 28. I get a sort of frightened feeling like butterflies in the stomach 
 
Response is **one** of: 
 
 - Not at all 
 - Occasionally 
 - Quite often 
 - Very often 
 
 29. I have lost interest in my appearance 
 
Response is **one** of: 
 
 - I take just as much care as ever 
 - I may not take quite as much care 
 - I don’t take as much care as I should 
 - Definitely 
 
 30. I feel restless as if I have to be on the move 
 
Response is **one** of: 
 
 - Not at all 
 - Not very much 
 - Quite a lot 
 - Very much indeed 
 
 31. I look forward with enjoyment to things 
 
Response is **one** of: 
 
 - As much as I ever did 
 - A bit less than I used to 
 - Definitely less than I used to 
 - Hardly at all 
 
 32. I get sudden feelings of panic 
 
Response is **one** of: 
 
 - Not at all 

  
 
 
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 - Not very often 
 - Quite often 
 - Very often indeed 
 
 33. I can enjoy a good book or radio or TV program 
 
Response is **one** of: 
 
 - Often 
 - Sometimes 
 - Not often 
 - Very seldom 
 
 34. Over the last week or so, how often have you been bothered by the following problems? 
 
(This is an information screen that requires no response) 
 
Click Next to continue.  
 
 35. Feeling nervous, anxious or on edge 
 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 36. Not being able to stop or control worrying 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 37. Worrying too much about different things 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 38. Trouble relaxing 
 
Response is **one** of: 
 

  
 
 
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 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 39. Being so restless that it is hard to sit still  
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 40. Becoming easily annoyed or irritable 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 41. Feeling afraid as if something awful might happen 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 42. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious distress) 
 
 43. In the last week or so, how often have you experienced the following. 

  
 
 
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(This is an information screen that requires no response) 
 
Click Next to continue.  
 
 44. I had sleep problems. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 45. I had nightmares. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 46. I had depression or felt dejected/downtrodden. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 47. I had jumpiness- I am easily frightened by sudden sounds or movements. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 

  
 
 
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 - 6 
 - 7 (Always) 
 
 48. I had the need to withdraw from others. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 49. I had irritability - I was easily agitated, annoyed or angered. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 50. I had frequent mood swings. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 51. I had a bad conscience, blamed myself, had guilty feelings. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 

  
 
 
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 52. I had fear of places or situations that remind me of the Intensive Care Unit. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 53. I had muscular tension. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 54. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious distress) 
 
 55. Over the last 2 weeks, how much have you been bothered by any of the following problems? 
 
(This is an information screen that requires no response) 
 
 Click Next to continue. 
 
 56. Pain 
 

  
 
 
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Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 57. Difficulty concentrating 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 58. Weakness 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 59. Feeling your heart pound or race 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 60. Shortness of breath (or other breathing problems) 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 61. Stiffness in joints or muscles 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 62. Constipation or diarrhea 
 
Response is **one** of: 
 

  
 
 
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Dated: 22 July 2020 
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 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 63. Nausea, gas, or indigestion 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 64. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious distres) 
 
 65. In general, how would you rate your current quality of life? 
 
Response is **one position** in this scale: 
 
 - 0 (Worst imaginable quality of life) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Best imaginable quality of life) 
 
 66. Currently I am able to: 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 

  
 
 
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Dated: 22 July 2020 
Page 59 of 116 
 
 
 67. … bathe myself em>(either a sponge bath, tub bath, or shower)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 68. … dress myself em>(like putting on a shirt, buttoning and zipping, etc.)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 69. … feed myselfem> (holding fork, cutting food, drinking from a glass)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 70. … get from a bed to a chair by myself 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 71. … control my bladder or bowels 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 72. … use the toilet by myself 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 73. … use the telephone em>(including looking up numbers and dialing)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 

  
 
 
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 74.  … get to places beyond walking distance em>(drive own car or travel alone in buses or taxis)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 75. … go shopping for groceries or clothes 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 76. … prepare my own meals 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 77. … do housework em>(wash dishes, clean floors, etc.)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 78. … take my own medicine 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 79. … handle my own money em>(write checks, pay bills)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 80. How much do you agree or disagree with each statement?  
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 81. I never give up. 
 

  
 
 
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Page 61 of 116 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 82. I do everything to get well. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 83. I keep fighting to get better. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 84. I am afraid of pain. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 85. I can hardly tolerate pain. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 86. I am tough to myself when in pain. 
 

  
 
 
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Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 87. I view my illness as a personal learning experience. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 88. I am able to turn my illness into something positive. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 89. I use my illness in a creative way.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 90. I am gloomy about recovery.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 91. I feel the future is bleak. 
 

  
 
 
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Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 92. I do not believe in a happy ending.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 93. I resign myself to my destiny.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 94. I reconcile myself to the inevitable.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 95. I accept whatever will happen. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 96. Please indicate how frequently or infrequently you’ve been having each experience over the past 3 
days, including today. 

  
 
 
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Page 64 of 116 
 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 97. I’m finding it difficult to stay focused on what’s happening in the present. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 98. I’m rushing through activities without being really attentive to them. 
 
Response is **one** of: 
 
 - Almost Always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 99. I’m doing jobs or tasks automatically, without being aware of what I'm doing. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 100. I’m finding myself preoccupied with the future or the past. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 101. I’m finding myself doing things without paying attention. 

  
 
 
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Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 102. Please help us improve the Blueprint program by answering some questions about it. We are 
interested in your honest opinion, whether positive or negative. 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 103. How would you rate the quality of the Blueprint program? 
 
Response is **one** of: 
 
 - Excellent 
 - Good 
 - Fair 
 - Poor 
 
 104. Did you get the kind of program that you wanted? 
 
Response is **one** of: 
 
 - Yes, definitely 
 - Yes, generally 
 - No, not really 
 - No, definitely not 
 
 105. To what extent has the Blueprint program met your needs? 
 
Response is **one** of: 
 
 - Almost all of my needs have been met 
 - Most of my needs have been met 
 - Only a few of my needs have been met 
 - None of my needs have been met 
 
 106. If a friend were in need of similar help, would you recommend the Blueprint program to him or 
her? 
 
Response is **one** of: 
 
 - Yes, generally 

  
 
 
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Dated: 22 July 2020 
Page 66 of 116 
 
 - Yes, generally 
 - No, not really 
 - No, definitely not 
 
 107. How satisfied are you with the amount of help you received in the Blueprint program? 
 
Response is **one** of: 
 
 - Very satisfied 
 - Mostly satisfied 
 - Indifferent or mildly dissatisfied 
 - Quite dissatisfied 
 
 108. Has the Blueprint program helped you to deal more effectively with your problems or stresses? 
 
Response is **one** of: 
 
 - Yes, it helped a great deal 
 - Yes, it helped somewhat 
 - No, it really didn't help 
 - No, it seemed to make things worse 
 
 109. In an overall, general sense, how satisfied are you with the Blueprint program? 
 
Response is **one** of: 
 
 - Very satisfied 
 - Mostly satisfied 
 - Indifferent or mildly dissatisfied 
 - Quite dissatisfied 
 
 110. If you were to decide about participating or not in the Blueprint program, would you do it again? 
 
Response is **one** of: 
 
 - Yes, definitely 
 - Yes, I think so 
 - No, I don't think so 
 - No, definitely not 
 
 111. Could you provide any comments about specific ways the Blueprint program helped or didn’t help 
you? 
 
Response is **free-form text**. 
 
 112. Click Next to submit your answers and see your results. 
 
(This is a score screen that requires no response) 
 
 113. Thank You! 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 67 of 116 
 
 
(This is an information screen that requires no response) 
 
Please click Next to exit the survey. 
 
I. T3 Survey 
 
T3 
 
 Third Survey 
 
 1. During the past month, have you been treated for depression, anxiety, PTSD, or any other 
psychiatric condition? 
 
Response is **Yes** or **No**. 
 
 2. In the past month, have you been treated for depression or depressed mood? 
 
Response is **Yes** or **No**. 
 
 3. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 4. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 5. In the past month, have you been treated for anxiety? 
 
Response is **Yes** or **No**. 
 
 6. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 7. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 8. In the past month, have you been treated for post-traumatic stress disorder (PTSD)? 
 
Response is **Yes** or **No**. 
 
 9. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 10. Were you treated by a psychiatrist, psychologist, or counselor? 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 68 of 116 
 
Response is **Yes** or **No**. 
 
 11. In the past month, have you been treated for chronic pain? 
 
Response is **Yes** or **No**. 
 
 12. Were you treated with medication? 
 
Response is **Yes** or **No**. 
 
 13. Were you treated by a psychiatrist, psychologist, or counselor? 
 
Response is **Yes** or **No**. 
 
 14. Since you were last discharged from the hospital, have you been admitted to the hospital again?   
 
Response is **Yes** or **No**. 
 
 15. How many times have you been admitted? 
 
Response is **one** of: 
 
 - Once 
 - 2 times 
 - 3 or more times  
 
 16. For the next questions, select the option that best fits your current situation. 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 17. I have someone to confide in or talk to about myself and my problems. 
 
Response is **one** of: 
 
 - Never 
 - Rarely 
 - Sometimes 
 - Usually 
 - Always 
 
 18. At the end of an average month, what describes how you usually feel when you are paying the 
bills? 
 
Response is **one** of: 
 
 - Short on money and need more to pay bills 
 - Barely have enough to pay bills and for basic needs 
 - Have enough for just a few extra things 

  
 
 
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Dated: 22 July 2020 
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 - Completely comfortable 
 
 19. Please select the response that describes how you felt in the past week. 
 
(This is an information screen that requires no response) 
 
Click Next to continue 
 
 20. I feel tense or wound up 
 
Response is **one** of: 
 
 - Not at all  
 - Time to time, occasionally 
 - A lot of the time 
 - Most of the time 
 
 21. I still enjoy the things I used to enjoy 
 
Response is **one** of: 
 
 - Definitely as much  
 - Not quite so much 
 - Only a little 
 - Hardly at all 
 
 22. I get a frightened feeling like something awful is about to happen 
 
Response is **one** of: 
 
 - Not at all 
 - A little, but it doesn’t worry me 
 - Yes, but not too badly 
 - Very definitely and quite badly 
 
 23. I can laugh and see the funny side of things 
 
Response is **one** of: 
 
 - As much as I always could 
 - Not quite so much now 
 - Definitely not so much now 
 - Not at all 
 
 24. Worrying thoughts go through my mind 
 
Response is **one** of: 
 
 - Only occasionally 
 - From time to time but not too often 

  
 
 
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 - A lot of the time 
 - A great deal of the time 
 
 25. I feel cheerful 
 
Response is **one** of: 
 
 - Most of the time 
 - Sometimes 
 - Not often 
 - Not at all 
 
 26. I can sit at ease and feel relaxed 
 
Response is **one** of: 
 
 - Definitely 
 - Usually 
 - Not often 
 - Not at all 
 
 27. I feel as if I am slowed down 
 
Response is **one** of: 
 
 - Not at all 
 - Sometimes 
 - Very often 
 - Nearly all of the time 
 
 28. I get a sort of frightened feeling like butterflies in the stomach 
 
Response is **one** of: 
 
 - Not at all 
 - Occasionally 
 - Quite often 
 - Very often 
 
 29. I have lost interest in my appearance 
 
Response is **one** of: 
 
 - I take just as much care as ever 
 - I may not take quite as much care 
 - I don’t take as much care as I should 
 - Definitely 
 
 30. I feel restless as if I have to be on the move 
 

  
 
 
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Page 71 of 116 
 
Response is **one** of: 
 
 - Not at all 
 - Not very much 
 - Quite a lot 
 - Very much indeed 
 
 31. I look forward with enjoyment to things 
 
Response is **one** of: 
 
 - As much as I ever did 
 - A bit less than I used to 
 - Definitely less than I used to 
 - Hardly at all 
 
 32. I get sudden feelings of panic 
 
Response is **one** of: 
 
 - Not at all 
 - Not very often 
 - Quite often 
 - Very often indeed 
 
 33. I can enjoy a good book or radio or TV program 
 
Response is **one** of: 
 
 - Often 
 - Sometimes 
 - Not often 
 - Very seldom 
 
 34. Over the last week or so, how often have you been bothered by the following problems? 
 
(This is an information screen that requires no response) 
 
Click Next to continue.  
 
 35. Feeling nervous, anxious or on edge 
 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 36. Not being able to stop or control worrying 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 72 of 116 
 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 37. Worrying too much about different things 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 38. Trouble relaxing 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 39. Being so restless that it is hard to sit still  
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 40. Becoming easily annoyed or irritable 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 
 - More than half the days 
 - Nearly every day  
 
 41. Feeling afraid as if something awful might happen 
 
Response is **one** of: 
 
 - Not at all 
 - A couple of days 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 73 of 116 
 
 - More than half the days 
 - Nearly every day  
 
 42. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious distress) 
 
 43. In the last week or so, how often have you experienced the following? 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 44. I had sleep problems. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 45. I had nightmares. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 74 of 116 
 
 46. I had depression or felt dejected/downtrodden. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 47. I had jumpiness- I am easily frightened by sudden sounds or movements. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 48. I had the need to withdraw from others. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 49. I had irritability - I was easily agitated, annoyed or angered. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 50. I had frequent mood swings. 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 75 of 116 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 51. I had a bad conscience, blamed myself, or had have guilty feelings. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 52. I had a fear of places or situations that remind me of the Intensive Care Unit. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 
 - 5 
 - 6 
 - 7 (Always) 
 
 53. In the past week or so, I had muscular tension. 
 
Response is **one position** in this scale: 
 
 - 1 (Never) 
 - 2 
 - 3 
 - 4 [default] 
 - 5 
 - 6 
 - 7 (Always) 
 
 54. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 76 of 116 
 
 
 - 0 (No distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious distress) 
 
 55. Over the last 2 weeks, how much have you been bothered by any of the following problems? 
 
(This is an information screen that requires no response) 
 
 Click Next to continue. 
 
 56. Pain 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 57. Difficulty concentrating 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 58. Weakness 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 59. Feeling your heart pound or race 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 77 of 116 
 
 
 60. Shortness of breath (or other breathing problems) 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 61. Stiffness in joints or muscles 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 62. Constipation or diarrhea 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 63. Nausea, gas, or indigestion 
 
Response is **one** of: 
 
 - Not bothered at all 
 - Bothered a little 
 - Bothered a lot 
 
 64. The last few questions asked how often you were bothered by the problems. Now, please share 
show how much distress the problem caused you: 
 
Response is **one position** in this scale: 
 
 - 0 (No distress) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Serious distress) 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 78 of 116 
 
 65. In general, how would you rate your current quality of life? 
 
Response is **one position** in this scale: 
 
 - 0 (Worst imaginable quality of life) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 [default] 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Best imaginable quality of life) 
 
 66. Currently I am able to: 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 67. … bathe myself (either a sponge bath, tub bath, or shower)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 68. … dress myself (like putting on a shirt, buttoning and zipping, etc.)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 69. … feed myself (holding fork, cutting food, drinking from a glass)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 70. … get from a bed to a chair by myself 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 79 of 116 
 
 71. … control my bladder or bowels 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 72. … use the toilet by myself 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 73. … use the telephone (including looking up numbers and dialing)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 74.  … get to places beyond walking distance (drive own car or travel alone in buses or taxis)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 75. … go shopping for groceries or clothes 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 76. … prepare my own meals 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 77. … do housework em>(wash dishes, clean floors, etc.)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 78. … take my own medicine 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 80 of 116 
 
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 79. … handle my own money (write checks, pay bills)   
 
Response is **one** of: 
 
 - Need no help 
 - Need some help or unable to do 
 
 80. How much do you agree or disagree with each statement?  
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 81. I never give up. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 82. I do everything to get well. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 83. I keep fighting to get better. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 84. I am afraid of pain. 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 81 of 116 
 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 85. I can hardly tolerate pain. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 86. I am tough to myself when in pain. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 87. I view my illness as a personal learning experience. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 88. I am able to turn my illness into something positive. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 89. I use my illness in a creative way.  

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 82 of 116 
 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 90. I am gloomy about recovery.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 91. I feel the future is bleak. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 92. I do not believe in a happy ending.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 93. I resign myself to my destiny.  
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 94. I reconcile myself to the inevitable.  

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 83 of 116 
 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 95. I accept whatever will happen. 
 
Response is **one** of: 
 
 - Totally disagree 
 - Disagree somewhat 
 - Neutral 
 - Agree somewhat 
 - Totally agree 
 
 96. Please indicate how frequently or infrequently you’ve been having each experience over the past 3 
days, including today. 
 
(This is an information screen that requires no response) 
 
Click Next to continue. 
 
 97. I’m finding it difficult to stay focused on what’s happening in the present. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 98. I’m rushing through activities without being really attentive to them. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 99. I’m doing jobs or tasks automatically, without being aware of what I'm doing. 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 84 of 116 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 100. I’m finding myself preoccupied with the future or the past. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 101. I’m finding myself doing things without paying attention. 
 
Response is **one** of: 
 
 - Almost always 
 - Very frequently 
 - Somewhat frequently 
 - Somewhat infrequently 
 - Very infrequently 
 - Almost never 
 
 102. Click Next to submit your answers and see your results. 
 
(This is a score screen that requires no response) 
 
 103. Thank You! 
 
(This is an information screen that requires no response) 
 
Please click Next to exit the survey. 
 
 
J. Weekly Check‐Ins 
 
 
Week 1 Check In  
# Week 1 Check In 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 85 of 116 
 
 Week 1 Check In 
 
Time for the 1-minute Blueprint weekly mini-survey! 
 
 1. Please select the response that describes how you felt in the past week. 
 
(This is an information screen that requires no response) 
 
Click Next to continue 
 
 2. I feel tense or wound up 
 
Response is **one** of: 
 
 - Not at all  
 - Time to time, occasionally 
 - A lot of the time 
 - Most of the time 
 
 3. I still enjoy the things I used to enjoy 
 
Response is **one** of: 
 
 - Definitely as much  
 - Not quite so much 
 - Only a little 
 - Hardly at all 
 
 4. I get a frightened feeling like something awful is about to happen 
 
Response is **one** of: 
 
 - Not at all 
 - A little, but it doesn’t worry me 
 - Yes, but not too badly 
 - Very definitely and quite badly 
 
 5. I can laugh and see the funny side of things 
 
Response is **one** of: 
 
 - As much as I always could 
 - Not quite so much now 
 - Definitely not so much now 
 - Not at all 
 
 6. Worrying thoughts go through my mind 
 
Response is **one** of: 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 86 of 116 
 
 - Only occasionally 
 - From time to time but not too often 
 - A lot of the time 
 - A great deal of the time 
 
 7. I feel cheerful 
 
Response is **one** of: 
 
 - Most of the time 
 - Sometimes 
 - Not often 
 - Not at all 
 
 8. I can sit at ease and feel relaxed 
 
Response is **one** of: 
 
 - Definitely 
 - Usually 
 - Not often 
 - Not at all 
 
 9. I feel as if I am slowed down 
 
Response is **one** of: 
 
 - Not at all 
 - Sometimes 
 - Very often 
 - Nearly all of the time 
 
 10. I get a sort of frightened feeling like butterflies in the stomach 
 
Response is **one** of: 
 
 - Not at all 
 - Occasionally 
 - Quite often 
 - Very often 
 
 11. I have lost interest in my appearance 
 
Response is **one** of: 
 
 - I take just as much care as ever 
 - I may not take quite as much care 
 - I don’t take as much care as I should 
 - Definitely 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 87 of 116 
 
 12. I feel restless as if I have to be on the move 
 
Response is **one** of: 
 
 - Not at all 
 - Not very much 
 - Quite a lot 
 - Very much indeed 
 
 13. I look forward with enjoyment to things 
 
Response is **one** of: 
 
 - As much as I ever did 
 - A bit less than I used to 
 - Definitely less than I used to 
 - Hardly at all 
 
 14. I get sudden feelings of panic 
 
Response is **one** of: 
 
 - Not at all 
 - Not very often 
 - Quite often 
 - Very often indeed 
 
 15. I can enjoy a good book or radio or TV program 
 
Response is **one** of: 
 
 - Often 
 - Sometimes 
 - Not often 
 - Very seldom 
 
 16.Howconfident do you feel using progressive muscle relaxation?  
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 88 of 116 
 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 17. That's okay. It is normal to feel a little unsure at first with progressive muscle relaxation. Most 
people find that their confidence improves with practice. You can do it! 
 
(This is an information screen that requires no response) 
 
 18. You are off to a great start. It is normal to feel this way about progressive muscle relaxation at this 
point. Remember to practice daily. Great work! 
 
(This is an information screen that requires no response) 
 
 19. : Wow, you really have the hang of progressive muscle relaxation. Remember to keep practicing. 
Great work! 
 
(This is an information screen that requires no response) 
 
 20. How helpful is using progressive muscle relaxation 
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 21. That’s OK. It often takes time to get comfortable with a new skill and see its benefits. Most people 
find that the more they practice progressive muscle relaxation, the more helpful they find it. Give it a try 
for awhile longer and see what you think. 
 
(This is an information screen that requires no response) 
 
 22. That's great. It sounds like progressive muscle relaxation might be a useful tool for you. Keep 
practicing—the more you use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 23. Great! It sounds like progressive muscle relaxation is a really useful tool for you. Keep practicing - 
the more you use it, the more helpful it is likely to be. 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 89 of 116 
 
 
(This is an information screen that requires no response) 
 
 24. How confident do you feel using pleasant imagery 
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 25. That's okay. It is normal to feel a little unsure at first with pleasant imagery. Most people find that 
their confidence improves with practice. You can do it. 
 
(This is an information screen that requires no response) 
 
 26. You are off to a great start. It is normal to feel this way about pleasant imagery at this point. 
Remember to practice daily. Great work! 
 
(This is an information screen that requires no response) 
 
 27. Wow, you really have the hang of pleasant imagery. Remember to keep practicing. Great work! 
 
(This is an information screen that requires no response) 
 
 28.Howhelpful is using pleasant imagery?  
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 90 of 116 
 
 - 90 
 - 100 (Extremely helpful) 
 
 29. That’s OK. It often takes time to get comfortable with a new skill and see its benefits. Most people 
find that the more they practice pleasant imagery, the more helpful they find it. Give it a try for awhile 
longer and see what you think. 
 
(This is an information screen that requires no response) 
 
 30. That's great. It sounds like pleasant imagery might be a useful tool for you. Keep practicing—the 
more you use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 31. Great! It sounds like pleasant imagery is a really useful tool for you. Keep practicing - the more you 
use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 32. Thank you! 
 
(This is a score screen that requires no response) 
 
You have completed the assessment.Click Next to submit your responses. 
 
Week 2 Check In  
# Week 1 Check In 
 
 Week 1 Check In 
 
Time for the 1-minute Blueprint weekly mini-survey! 
 
 1. Please select the response that describes how you felt in the past week. 
 
(This is an information screen that requires no response) 
 
Click Next to continue 
 
 2. I feel tense or wound up 
 
Response is **one** of: 
 
 - Not at all  
 - Time to time, occasionally 
 - A lot of the time 
 - Most of the time 
 
 3. I still enjoy the things I used to enjoy 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 91 of 116 
 
 
Response is **one** of: 
 
 - Definitely as much  
 - Not quite so much 
 - Only a little 
 - Hardly at all 
 
 4. I get a frightened feeling like something awful is about to happen 
 
Response is **one** of: 
 
 - Not at all 
 - A little, but it doesn’t worry me 
 - Yes, but not too badly 
 - Very definitely and quite badly 
 
 5. I can laugh and see the funny side of things 
 
Response is **one** of: 
 
 - As much as I always could 
 - Not quite so much now 
 - Definitely not so much now 
 - Not at all 
 
 6. Worrying thoughts go through my mind 
 
Response is **one** of: 
 
 - Only occasionally 
 - From time to time but not too often 
 - A lot of the time 
 - A great deal of the time 
 
 7. I feel cheerful 
 
Response is **one** of: 
 
 - Most of the time 
 - Sometimes 
 - Not often 
 - Not at all 
 
 8. I can sit at ease and feel relaxed 
 
Response is **one** of: 
 
 - Definitely 
 - Usually 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 92 of 116 
 
 - Not often 
 - Not at all 
 
 9. I feel as if I am slowed down 
 
Response is **one** of: 
 
 - Not at all 
 - Sometimes 
 - Very often 
 - Nearly all of the time 
 
 10. I get a sort of frightened feeling like butterflies in the stomach 
 
Response is **one** of: 
 
 - Not at all 
 - Occasionally 
 - Quite often 
 - Very often 
 
 11. I have lost interest in my appearance 
 
Response is **one** of: 
 
 - I take just as much care as ever 
 - I may not take quite as much care 
 - I don’t take as much care as I should 
 - Definitely 
 
 12. I feel restless as if I have to be on the move 
 
Response is **one** of: 
 
 - Not at all 
 - Not very much 
 - Quite a lot 
 - Very much indeed 
 
 13. I look forward with enjoyment to things 
 
Response is **one** of: 
 
 - As much as I ever did 
 - A bit less than I used to 
 - Definitely less than I used to 
 - Hardly at all 
 
 14. I get sudden feelings of panic 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 93 of 116 
 
Response is **one** of: 
 
 - Not at all 
 - Not very often 
 - Quite often 
 - Very often indeed 
 
 15. I can enjoy a good book or radio or TV program 
 
Response is **one** of: 
 
 - Often 
 - Sometimes 
 - Not often 
 - Very seldom 
 
 16.Howconfident do you feel using progressive muscle relaxation?  
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 17. That's okay. It is normal to feel a little unsure at first with progressive muscle relaxation. Most 
people find that their confidence improves with practice. You can do it! 
 
(This is an information screen that requires no response) 
 
 18. You are off to a great start. It is normal to feel this way about progressive muscle relaxation at this 
point. Remember to practice daily. Great work! 
 
(This is an information screen that requires no response) 
 
 19. Wow, you really have the hang of progressive muscle relaxation. Remember to keep practicing. 
Great work! 
 
(This is an information screen that requires no response) 
 
 20. How helpful is using progressive muscle relaxation 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 94 of 116 
 
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 21. That’s OK. It often takes time to get comfortable with a new skill and see its benefits. Most people 
find that the more they practice progressive muscle relaxation, the more helpful they find it. Give it a try 
for awhile longer and see what you think. 
 
(This is an information screen that requires no response) 
 
 22. That's great. It sounds like progressive muscle relaxation might be a useful tool for you. Keep 
practicing—the more you use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 23. Great! It sounds like progressive muscle relaxation is a really useful tool for you. Keep practicing - 
the more you use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 24. How confident do you feel using pleasant imagery? 
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 95 of 116 
 
 
 25. That's okay. It is normal to feel a little unsure at first with pleasant imagery. Most people find that 
their confidence improves with practice. You can do it. 
 
(This is an information screen that requires no response) 
 
 26. You are off to a great start. It is normal to feel this way about pleasant imagery at this point. 
Remember to practice daily. Great work! 
 
(This is an information screen that requires no response) 
 
 27. Wow, you really have the hang of pleasant imagery. Remember to keep practicing. Great work! 
 
(This is an information screen that requires no response) 
 
 28.Howhelpful is using pleasant imagery?  
 
This question includes an image. 
 
Response is **one position** in this scale: 
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 29. That’s OK. It often takes time to get comfortable with a new skill and see its benefits. Most people 
find that the more they practice pleasant imagery, the more helpful they find it. Give it a try for awhile 
longer and see what you think. 
 
(This is an information screen that requires no response) 
 
 30. That's great. It sounds like pleasant imagery might be a useful tool for you. Keep practicing—the 
more you use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 31. Great! It sounds like pleasant imagery is a really useful tool for you. Keep practicing - the more you 
use it, the more helpful it is likely to be. 
 
(This is an information screen that requires no response) 
 
 32. Thank you! 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 96 of 116 
 
 
(This is a score screen that requires no response) 
 
You have completed the assessment.Click Next to submit your responses. 
 
Week 2 Check In 
Time for the 1-minute Blueprint weekly mini-survey! 
 
 1. Please select the response that describes how you felt in the  past week .  
 
 (This is an information screen that requires no response)  
 
Click  Next to continue 
 
 2. I feel tense or wound up  
 
 Response is **one** of:  
 
 - Not at all  
 - Time to time, occasionally 
 - A lot of the time 
 - Most of the time 
 
 3. I still enjoy the things I used to enjoy  
 
 Response is **one** of:  
 
 - Definitely as much  
 - Not quite so much 
 - Only a little 
 - Hardly at all 
 
 4. I get a frightened feeling like something awful is about to happen  
 
 Response is **one** of:  
 
 - Not at all 
 - A little, but it doesn’t worry me 
 - Yes, but not too badly 
 - Very definitely and quite badly 
 
 5. I can laugh and see the funny side of things  
 
 Response is **one** of:  
 
 - As much as I always could 
 - Not quite so much now 
 - Definitely not so much now 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 97 of 116 
 
 - Not at all 
 
 6. Worrying thoughts go through my mind  
 
 Response is **one** of:  
 
 - Only occasionally 
 - From time to time but not too often 
 - A lot of the time 
 - A great deal of the time 
 
 7. I feel cheerful  
 
 Response is **one** of:  
 
 - Most of the time 
 - Sometimes 
 - Not often 
 - Not at all 
 
 8. I can sit at ease and feel relaxed  
 
 Response is **one** of:  
 
 - Definitely 
 - Usually 
 - Not often 
 - Not at all 
 
 9. I feel as if I am slowed down  
 
 Response is **one** of:  
 
 - Not at all 
 - Sometimes 
 - Very often 
 - Nearly all of the time 
 
 10. I get a sort of frightened feeling like butterflies in the stomach  
 
 Response is **one** of:  
 
 - Not at all 
 - Occasionally 
 - Quite often 
 - Very often 
 
 11. I have lost interest in my appearance  
 
 Response is **one** of:  

  
 
 
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 - I take just as much care as ever 
 - I may not take quite as much care 
 - I don’t take as much care as I should 
 - Definitely 
 
 12. I feel restless as if I have to be on the move  
 
 Response is **one** of:  
 
 - Not at all 
 - Not very much 
 - Quite a lot 
 - Very much indeed 
 
 13. I look forward with enjoyment to things  
 
 Response is **one** of:  
 
 - As much as I ever did 
 - A bit less than I used to 
 - Definitely less than I used to 
 - Hardly at all 
 
 14. I get sudden feelings of panic  
 
 Response is **one** of:  
 
 - Not at all 
 - Not very often 
 - Quite often 
 - Very often indeed 
 
 15. I can enjoy a good book or radio or TV program  
 
 Response is **one** of:  
 
 - Often 
 - Sometimes 
 - Not often 
 - Very seldom 
 
 16. Thank you! 
 
 (This is a score screen that requires no response)  
 
You have completed the assessment. Click  Next to submit your responses. 
 
 17. How    confident  do you feel using pleasant activities ?  
 

  
 
 
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 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 18. This feeling is pretty normal at first with  pleasant activities . You just have to make a plan--and 
stick with it! You can do it... 
 
 (This is an information screen that requires no response)  
 
 19. This is a good start. Remember, it can be tough to find the time for  pleasant activities . But you 
deserve it--and it can help. Hang in there... 
 
 (This is an information screen that requires no response)  
 
 20. Excellent! You are a  pleasant activities expert. Keep it going...great work! 
 
 (This is an information screen that requires no response)  
 
 21. How  helpfu l is using  pleasant activities ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 22. That’s OK.  Try to keep giving this skill a chance, because the more you take time for  pleasant 
activities , the more you get 'you' time. Give it a try for awhile longer and see what you think. 

  
 
 
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 (This is an information screen that requires no response)  
 
 23. Great!. It sounds like  pleasant activities are working for you. Keep making the time for these 
activities, because the more you do the better you could feel. 
 
 (This is an information screen that requires no response)  
 
 24. Wow! It seems like  pleasant activities is a really useful tool for you. Keep taking the time to do 
these - the more you use it, the more helpful it is likely to be. 
 
 (This is an information screen that requires no response)  
 
 25. How    confident  do you feel using activity rest cycle ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 26. That's okay because the  activity rest cycle can be tough to use at first. Try to focus on one activity 
at the beginning. This will help your confidence. You can do it! 
 
 (This is an information screen that requires no response)  
 
 27. You are off to a great start. It is normal not to feel like an  activity rest cycle expert at this point. 
Remember to practice daily. Great work! 
 
 (This is an information screen that requires no response)  
 
 28. Boom! You really have the hang of the  activity rest cycle.  Remember to keep practicing. 
Excellent! 
 
 (This is an information screen that requires no response)  
 
 29. How  helpful  is using  activity rest cycle ?  
 
 This question includes an image.  
 

  
 
 
Protocol version: 1.1  
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 Response is **one position** in this scale:  
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 30. It can take a little time to work through a new skill and figure out how it might work best. Most 
people find that the more they practice  activity rest cycle , the more helpful they find it. Give it a try for 
awhile longer and see what you think. 
 
 (This is an information screen that requires no response)  
 
 31. Really good! It sounds like  activity rest cycle is a good addition to the toolbox. Keep practicing—
the more you use it, the more helpful it is likely to be. 
 
 (This is an information screen that requires no response)  
 
 32. Wonderful! It sounds like  activity rest cycle is a keeper for you. Keep practicing - the more you use 
it, the more helpful it is likely to be. 
 
 (This is an information screen that requires no response)  
 
Week 3 Check In 
Time for the 1-minute Blueprint weekly mini-survey! 
 
 1. Please select the response that describes how you felt in the  past week .  
 
 (This is an information screen that requires no response)  
 
Click  Next to continue 
 
 2. I feel tense or wound up  
 
 Response is **one** of:  
 
 - Not at all  
 - Time to time, occasionally 
 - A lot of the time 
 - Most of the time 
 

  
 
 
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 3. I still enjoy the things I used to enjoy  
 
 Response is **one** of:  
 
 - Definitely as much  
 - Not quite so much 
 - Only a little 
 - Hardly at all 
 
 4. I get a frightened feeling like something awful is about to happen  
 
 Response is **one** of:  
 
 - Not at all 
 - A little, but it doesn’t worry me 
 - Yes, but not too badly 
 - Very definitely and quite badly 
 
 5. I can laugh and see the funny side of things  
 
 Response is **one** of:  
 
 - As much as I always could 
 - Not quite so much now 
 - Definitely not so much now 
 - Not at all 
 
 6. Worrying thoughts go through my mind  
 
 Response is **one** of:  
 
 - Only occasionally 
 - From time to time but not too often 
 - A lot of the time 
 - A great deal of the time 
 
 7. I feel cheerful  
 
 Response is **one** of:  
 
 - Most of the time 
 - Sometimes 
 - Not often 
 - Not at all 
 
 8. I can sit at ease and feel relaxed  
 
 Response is **one** of:  
 
 - Definitely 

  
 
 
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 - Usually 
 - Not often 
 - Not at all 
 
 9. I feel as if I am slowed down  
 
 Response is **one** of:  
 
 - Not at all 
 - Sometimes 
 - Very often 
 - Nearly all of the time 
 
 10. I get a sort of frightened feeling like butterflies in the stomach  
 
 Response is **one** of:  
 
 - Not at all 
 - Occasionally 
 - Quite often 
 - Very often 
 
 11. I have lost interest in my appearance  
 
 Response is **one** of:  
 
 - I take just as much care as ever 
 - I may not take quite as much care 
 - I don’t take as much care as I should 
 - Definitely 
 
 12. I feel restless as if I have to be on the move  
 
 Response is **one** of:  
 
 - Not at all 
 - Not very much 
 - Quite a lot 
 - Very much indeed 
 
 13. I look forward with enjoyment to things  
 
 Response is **one** of:  
 
 - As much as I ever did 
 - A bit less than I used to 
 - Definitely less than I used to 
 - Hardly at all 
 
 14. I get sudden feelings of panic  

  
 
 
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 Response is **one** of:  
 
 - Not at all 
 - Not very often 
 - Quite often 
 - Very often indeed 
 
 15. I can enjoy a good book or radio or TV program  
 
 Response is **one** of:  
 
 - Often 
 - Sometimes 
 - Not often 
 - Very seldom 
 
 16. Thank you! 
 
 (This is a score screen that requires no response)  
 
You have completed the assessment. Click Next to submit your responses. 
 
 17. How    confident  do you feel recognizing unhelpful thoughts ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 18. This is totally normal. Try to work on recognizing unhelpful thoughts when you are in certain 
situations or places. Your confidence will improve as you practice. You can do it! 
 
 (This is an information screen that requires no response)  
 
 19. OK, really good start!  Everybody struggles a bit with recognizing unhelpful thoughts at this point. 
Remember to practice using positive coping thoughts . Great work! 
 
 (This is an information screen that requires no response)  

  
 
 
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Dated: 22 July 2020 
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 20. Wow, you really have the hang of using coping thoughts to replace negative thoughts.  Remember 
to keep practicing. Great work! 
 
 (This is an information screen that requires no response)  
 
 21. How    helpful  is recognizing unhelpful thoughts  
 ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 22. That’s OK. But before you give up on  using positive coping thoughts , remember that many people 
start to see the benefits after a couple of weeks or more. Give it a try for awhile longer and see what 
you think. 
 
 (This is an information screen that requires no response)  
 
 23. That's great. It seems like you are having success with recognizing unhelpful thoughts . Keep 
practicing the positive coping thoughts —the more you use them, the more helpful they will be in tough 
situations. 
 
 (This is an information screen that requires no response)  
 
 24. Fantastic! It seems like recognizing unhelpful thoughts and replacing them with positive coping 
thoughts is another keeper for you. Keep practicing - the more you do, the more confident you'll be--
and the more helpful it is likely to be. 
 
 (This is an information screen that requires no response)  
 
 25. How confident do you feel using fast relax ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 

  
 
 
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 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 26. This is OK.  Fast relax is a brief skill, but can take some practice. Try using cues during the day 
(phone rings, you sit down, etc) to remind yourself to use it. You can do it! 
 
 (This is an information screen that requires no response)  
 
 27. OK, great! The key is just doing  fast relax a lot during the day. Use cues to trigger it (phone call, 
sitting down, etc). Great work! 
 
 (This is an information screen that requires no response)  
 
 28. You're a  fast relax expert now! Remember to keep practicing frequently during the day. Great 
work! 
 
 (This is an information screen that requires no response)  
 
 29. How helpful is using fast relax ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all helpful) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely helpful) 
 
 30. Try to give it a little more time. Most people find that the more they do  fast relax during the day, the 
more helpful they find it. Give it a try for awhile longer and see what you think. 
 
 (This is an information screen that requires no response)  
 
 31. OK, good--another keeper for the toolbox! Keep practicing fast relax frequently through the day. 
Use time or cues to remind yourself. Great! 

  
 
 
Protocol version: 1.1  
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 (This is an information screen that requires no response)  
 
 32. This is great. Let's remember that fast relax is a really useful tool for you. Keep practicing - the 
more you use it, the more helpful it is likely to be. 
 
 (This is an information screen that requires no response)  
 
Week 4 Check In 
Time for the 1-minute Blueprint weekly mini-survey! 
 
 1. How confident do you feel recognizing unhelpful thoughts ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 2. How helpful is recognizing unhelpful thoughts ?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 3. How confident do you feel fast relax ?  

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
Page 108 of 116 
 
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 4. How helpful is fast relax?  
 
 This question includes an image.  
 
 Response is **one position** in this scale:  
 
 - 0 (Not at all confident) 
 - 10 
 - 20 
 - 30 
 - 40 
 - 50 
 - 60 
 - 70 
 - 80 
 - 90 
 - 100 (Extremely confident) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
Protocol version: 1.1  
Dated: 22 July 2020 
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Appendix 4: Assessment Tools 
A. Callahan Cognitive Screen 
 
 
 
B. Columbia Suicide Severity Rating Scale (C‐SSRS) 
 
 

  
 
 
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Appendix 5: Study Contact Information 
 
Principal Investigator 
Christopher E. Cox, MD, MPH 
Division of Pulmonary Allergy & Critical Care 
Box 102043 
Durham, NC 27710 
Phone: 919-681-7232 
Email: christopher.cox@duke.edu 
Pattern Health 
Jennifer McLaughlin, Director-Program 
Management 
Email: jmclaughlin@pattern.health  
Email: support@pattern.health  
Phone Number: 844-877-7827 
 
 
Co-Investigator(s) 
Laura Porter, Ph.D. 
Behavioral Medicine 
Box 90399 
Durham, NC 27710 
Phone: 919-416-3436 
Email: laura.porter@duke.edu 
 
Sarah Kelleher, Ph.D. 
Behavioral Medicine 
2200 W. Main St., Suite 340 
Durham, NC 27705 
Phone: 919-416-3405 
Email: sarah.kelleher@duke.edu  
DSMB Members 
Erin Kross, MD (Chair) 
University of Washington 
ekross@uw.edu 
Phone: 206-744-4649 (work) 
 
Jennifer Steel, PhD 
University of Pittsburgh Medical Center 
steejl@UPMC.edu 
Phone: 412-692-2041 (work) and 412-726-3480 
(cell) 
 
Edward Valachovic, PhD, MA 
School of Public Health, University at Albany 
State University of New York 
evalachovic@albany.edu 
Phone: 518-408-2339 (work)  
 
Study Team 
Allie Frear, CRC Sr.  
Project Manager 
Division of Pulmonary, Allergy & Critical Care 
Phone: 919-684-8914 
Email: allie.frear@duke.edu 
 
Study Sponsor 
Lora Reineck, MD 
NHLBI Program Officer 
Email: lora.reineck@nih.gov 
Brittany McDowell, CRC  
Lead Clinical Research Coordinator 
Division of Pulmonary, Allergy & Critical Care 
Phone: 919-613-6833 
Email: brittany.mcodwell@duke.edu 
 
Vijoli Cermak, CRC  
Primary Study Clinical Research Coordinator 
Division of Pulmonary, Allergy & Critical Care 
Phone: 919-660-6605