Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD), Suicidal Ideation, Suicide Attempt
Sponsor: Ohio State University

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PROTOCOL TITLE: 
Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk  
among Patients with PTSD 
 
OVERALL PRINCIPAL INVESTIGATOR: 
Name: Craig Bryan, PsyD, ABPP 
Department: Department of Psychiatry and Behavioral Health 
University of Vermont 
Telephone Number: (614) 366-2314 
Email Address: craig.bryan@osumc.edu 
 
OSU PRINCIPAL INVESTIGATOR: 
Name: C. Rosie Bauder, PhD, MPH 
Department: Department of Psychiatry and Behavioral Health 
Telephone Number: (614) 814-0119 
Email Address: rosie.bauder@osumc.edu 
 
UTHSCSA PRINCIPAL INVESTIGATOR: 
Name: Alan Peterson, PhD, ABPP 
Department: Department of Psychiatry and Behavioral Sciences 
Telephone Number: (210) 694-6277562-6700 
Email Address: petersona3@uthscsa.edu 
 
Funding Mechanism: Department of Defense FY23 Peer Reviewed Medical Research Program 
(PRMRP) Contract: HT94252410360 
Funding Dates: 06/15/2024 to 06/14/2028 
 
Mays Cancer Center/CTMS#  
 
 
 
 
 
 
 
N/A ☒ 
 
VERSION NUMBER/DATE: V1, 07/10/25 
 
 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS  
TABLE OF CONTENTS .............................................................................................................................. 3 
1. STUDY SYNOPSIS .................................................................................................................................. 5 
1.1 
Study Schema ................................................................................................................................ 6 
1.2 Schedule of Events (SOE) ................................................................................................................... 6 
2. INTRODUCTION ..................................................................................................................................... 7 
2.1 Background ......................................................................................................................................... 7 
2.2 Risk/Benefit Assessment ..................................................................................................................... 8 
3. OBJECTIVES AND ENDPOINTS ........................................................................................................... 9 
4. STUDY DESIGN .................................................................................................................................... 10 
4.1 Overall Design ................................................................................................................................... 10 
4.2 Scientific Rationale for Study Design ............................................................................................... 10 
4.3 Justification for Intervention ............................................................................................................. 10 
4.4 End-Of-Study Definition ................................................................................................................... 11 
5. STUDY SETTING .................................................................................................................................. 11 
6. STUDY POPULATION .......................................................................................................................... 11 
6.1 Inclusion Criteria ............................................................................................................................... 11 
6.2 Exclusion Criteria .............................................................................................................................. 12 
6.3 Inclusion of Vulnerable or Special Populations 
                                                         N/A ☒ 12 
6.4 Lifestyle Considerations 
                                                                                                N/A ☒ 12 
6.5 Screen Failures .................................................................................................................................. 12 
6.6 Strategies for Recruitment and Retention ......................................................................................... 12 
7. STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ...................................... 13 
7.1 Administration of Study Intervention(s) or Experimental Manipulation(s) ...................................... 13 
7.2 Fidelity............................................................................................................................................... 14 
7.3 Measures to Minimize Bias: Randomization and Blinding                                                   N/A ☐ 15 
7.4 Study Intervention/Experimental Manipulation Adherence                                                   N/A ☐ 15 
7.5 Concomitant Therapy                                                                                                             N/A ☐ 15 
8. DISCONTINUATION AND WITHDRAWAL ...................................................................................... 15 
8.1 Discontinuation of Study Intervention or Experimental Manipulation ............................................. 15 
8.2 Participant Discontinuation/Withdrawal from the Study .................................................................. 15 
8.3 Lost to Follow-up                                                                                                                   N/A ☐ 16 
9. STUDY ASSESSMENTS AND PROCEDURES................................................................................... 16 

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9.1 Screening Procedures ........................................................................................................................ 16 
9.1.1 Screening activities performed prior to obtaining informed consent ......................................... 16 
9.1.2 Screening activities performed after a consent for screening has been signed .......................... 17 
9.2 Study Evaluations & Procedures ....................................................................................................... 17 
9.2.1 Visits and Procedures ................................................................................................................. 17 
9.2.1 Biospecimen Evaluations                                                                                                    N/A ☒ 22 
9.2.2 Samples for Genetic/Genomic Analysis                                                                             N/A ☒ 22 
9.3 Safety Assessments                                                                                                                N/A ☐ 22 
9.4 Adverse Events and Serious Adverse Events. ................................................................................... 23 
9.5 Unanticipated Problems .................................................................................................................... 23 
9.6 Reporting of Pregnancy                                                                                                         N/A ☒ 24 
10. STATISTICAL CONSIDERATIONS .................................................................................................. 24 
10.1 Statistical Hypothesis ...................................................................................................................... 24 
10.2 Sample Size Determination ............................................................................................................. 24 
10.3 Populations for Analyses ................................................................................................................. 24 
10.4 Statistical Analyses.......................................................................................................................... 24 
11. REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS ............................. 27 
11.1 Informed Consent Process ............................................................................................................... 27 
11.2 Study Discontinuation and Closure ................................................................................................. 27 
11.3 Confidentiality and Privacy ............................................................................................................. 28 
11.4 Future use of Stored Specimens and Data                                                                           N/A ☐ 30 
11.5 Safety and Clinical Monitoring ....................................................................................................... 30 
11.6 Quality Assurance and Quality Control .......................................................................................... 31 
11.7 Data Handling and Record Keeping ................................................................................................ 31 
11.8 Protocol Deviations and Non-Compliance ...................................................................................... 32 
11.9 Collaborative Agreements                                                                                                   N/A ☐ 32 
11.10 Conflict of Interest Policy ............................................................................................................. 33 
12. PUBLICATION POLICY ..................................................................................................................... 33 
13. ABBREVIATIONS ............................................................................................................................... 33 
14. REFERENCES ...................................................................................................................................... 34 
16. PLAN FOR REGULATORY OVERSIGHT ........................................................................................ 38 
 
 

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1. STUDY SYNOPSIS 
Protocol Information  Description  
Study Title 
Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide 
Risk among Patients with PTSD 
Study Design 
Randomized Clinical Trial 
Objectives/ 
Specific Aims 
The objective of this research is to determine if suicidal behaviors can be 
significantly reduced when massed Cognitive Processing Therapy (mCPT) is 
enhanced with Crisis Response Planning (CRP). 150 military personnel meeting 
diagnostic criteria for PTSD or subthreshold PTSD who also report active 
suicidal ideation within the past week and/or suicidal behavior within the 
preceding month will be enrolled. 
Specific Aims  
Aim 1: Determine if the addition of CRP to CPT reduces suicide attempts.  
Aim 2: Identify early markers of treatment response and relapse of suicide risk. 
Aim 3: Identify treatment content and design features that influence treatment 
effectiveness and acceptability. 
Research 
Intervention(s)  
Massed Cognitive Processing Therapy (mCPT): Cognitive processing therapy 
(CPT) is a trauma-focused treatment that involves learning to recognize and 
challenge thoughts related to the traumatic experience.  During this treatment, 
patients are asked to think about past traumatic experience and beliefs about the 
meaning of the traumatic event, as well as current beliefs about themselves and 
others. Topics such as problematic thinking, beliefs, safety, trust, power and 
control, esteem, and intimacy are discussed. CPT sessions will be scheduled 
daily for 10 consecutive business days (i.e., “massed” CPT). 
Crisis Response Planning (CRP): CRP is a collaborative process wherein a 
suicidal person provides a narrative description of a recent suicidal crisis or acute 
period of emotional arousal then creates a plan that lists indicators of acute 
affective arousal and strategies the person could use to regulate this arousal (e.g., 
self- management strategies, reasons for living, sources of social support, 
professional support).  
Setting/Approach 
Treatment will be provided and data collected at the Carl R. Darnall Army 
Medical Center (CRDAMC) located on Fort Hood.  
Study Population 
Active duty service members and veterans at least 18 years of age seeking care 
for PTSD symptoms who have experienced active suicidal ideation within the 
past week and/or suicidal behavior within the preceding month. 
Sample Size 
Number of participants to be consented to determine eligibility: 190 (anticipating 
20% of participants may screen out 
Target number of randomized (or enrolled) participants: 150 
Participant Duration 
Approximately 13 months to complete treatment and follow-up.  
Study Duration  
48 months from when the study opens to enrollment until completion of data 
analyses. 
 
 
 

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1.1 STUDY SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.2 SCHEDULE OF EVENTS (SOE) 
Study Procedures & Assessments 
 
Visit Schedule 
Week 
BL 
Intake 
1 
2 
4 
13 26 
39 52 
Consent 
R 
 
 
 
 
 
 
 
 
Randomization (when determined eligible) 
 
R 
 
 
 
 
 
 
 
Interventions (mCPT with or without CRP) 
 
 
 
 
 
 
 
 
 
Massed Cognitive Processing Therapy (mCPT) 
 
 
1x/day 
 
 
 
 
 
Crisis Response Planning (CRP) or Treatment as Usual (TAU) 
 
 
R 
 
 
 
 
 
 
Booster Sessions 
 
 
 
 
up to 3 over the 
follow-up year 
Adverse Event Reporting 
 
R 
R 
R 
R 
R 
R 
R 
R 
Assessments: 
R 
R 
R 
R 
R 
R 
R 
R 
R 
1. Demographic and Military Service Characteristics 
x 
 
 
 
 
 
 
 
 
2. History of Head Injuries Questionnaire + Addendum (HHI+HHI-A) 
x 
 
 
 
 
 
 
 
 
3. Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-
R) 
x 
I 
x* 
SR 
x* 
SR 
x* 
SR 
x* 
I 
x* 
I 
x* 
I 
x* 
I 
x* 
I 
4. Scale for Suicide Ideation (SSI) 
x 
x 
x 
x 
x 
x 
x 
x 
x 
5. Interpersonal Needs Questionnaire (INQ) 
x 
 
 
 
 
x 
x 
x 
x 
6. Beck Hopelessness Scale (BHS) 
x 
 
 
 
 
x 
x 
x 
x 
7. Suicide Cognitions Scale-Revised (SCS-R) 
x 
x 
x 
x 
x 
x 
x 
x 
x 
8. Difficulties with Emotion Regulation Scale-Short Form (DERS-SF) 
x 
 
 
 
 
x 
x 
x 
x 
Informed Consent & Baseline Assessment 
Randomization 
Massed Cognitive Processing Therapy 
+ Treatment as Usual 
Massed Cognitive Processing Therapy 
+ Crisis Response Planning 
4-, 13-, 26-, 39-, and 52-week Follow-up Assessments 
Figure 1. Research Design and Overview 

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9. Monetary Choice Questionnaire (MCQ) 
x 
 
 
 
 
x 
x 
x 
x 
10. Behavioral Inhibition System and the Behavioral Activation System 
(BIS/BAS)  
x 
 
 
 
 
x 
x 
x 
x 
11. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) with 
Selection of Index Events (SOIE) 
x 
 
 
 
 
 
 
 
 
12. Life Events Checklist (LEC) 
x 
 
 
 
 
 
 
 
 
13. PTSD Checklist for DSM-5 (PCL-5)** 
 
x 
x 
x 
x 
x 
x 
x 
x 
14. Posttraumatic Cognitions Inventory (PTCI-9) 
 
x 
x 
x 
x 
x 
x 
x 
x 
15. Satisfaction with Therapy and Therapist Scale – Revised (STTS-R) 
 
 
 
x 
 
 
 
 
 
16. Cornell Services Index-Short Form (CSI-SF) 
x 
 
 
 
 
x 
x 
x 
x 
17. PROMIS Computer Adaptive Tests (PROMIS- CATs) 
 
x 
x 
x 
x 
x 
x 
x 
x 
18. Clinical Global Impression (CGI) 
 
 
x 
x 
 
 
 
 
 
19. Ecological Momentary Assessment (EMA) 
 
6x/day for 
28 days 
 
 
 
 
20. Fitbit 
 
for 28 days 
 
 
 
 
21. Qualitative Interview 
 
 
 
 
x 
 
 
 
 
All activities are for research. 
* “Since your last assessment” version 
** “In the past week” version for all assessments. 
I = Interview; SR =Self-report 
 
2. INTRODUCTION 
2.1 BACKGROUND  
Suicide is a significant threat to military readiness. Suicide prevention in military personnel is one 
of the highest priorities of the Department of Defense (DoD). Despite the DoD’s considerable 
investment in suicide prevention over the past 15 years, military suicide rates remain elevated (Ovis, 
2021; Suicide Prevention and Response Independent Review Committee, 2023). Concerns about rising 
suicide rates are not limited to military personnel, however; suicide rates have also increased over the 
past two decades in both veteran (Department of Veterans Affairs, 2019) and civilian populations (Xu 
et al., 2021). The suicide rate in veterans is now 1.5 times the rate of non-veterans, with approximately 
20 U.S. military personnel and veterans dying by suicide each day (Department of Veterans Affairs, 
2019). 
Rapid reductions in suicidal ideation decrease risk for suicidal behavior. Research shows that 
trajectories of suicidal ideation are heterogeneous (e.g., some patients 
take longer to recover than others) and are differentially associated 
with risk of suicidal behavior. PI Bryan has shown, for instance, that 
faster reductions in suicidal ideation among military personnel are 
associated with significantly reduced risk of suicidal behavior (Lee et 
al., 2020). Similar patterns have been observed in non-military settings 
(Czyz et al, 2012, 2015; Prinstein et al., 2008; Sicotte et al., 2023), 
suggesting rapid (and early) reductions in suicidal ideation may 
underlie the effectiveness of evidence-based suicide-focused 
interventions like crisis response planning (CRP). CRP is a 
collaborative, patient-centered intervention that focuses on several 
key components: (1) warning signs, (2) self-regulatory strategies, (3) 
reasons for living, (4) sources of social support, and (5) professional 
and crisis services. An example CRP is displayed in Figure 1. In a 
DoD-funded RCT previously conducted by PI Bryan 
Figure1. Sample CRP 

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(W81XWH1020181), acutely suicidal military personnel who received CRP showed significantly 
faster reductions in suicide ideation during the following month and were 76% less likely to attempt 
suicide as compared to military personnel receiving treatment as usual (Bryan et al., 2017). Subsequent 
research by PI Bryan shows that CRP’s effects on suicidal ideation can be observed within hours of the 
intervention (Bryan et al., 2017), confirming the intervention’s rapid effects. Although promising, to 
date this is the only RCT of CRP that has been conducted with military, veteran, or civilian 
participants. As noted by the Defense Centers of Excellence for Psychological Health and Traumatic 
Brain Injury (PHCoE), the quality of evidence supporting CRP’s effectiveness therefore remains low 
(Workman et al., 2021). For this reason, the PHCoE identified additional CRP-focused efficacy 
research as one of the DoD’s most important suicide prevention research gaps in their 2020 research 
gaps report; only lethal means safety strategies ranked higher (Workman et al., 2021). Informed by 
these identified research gaps, we propose to evaluate the CRP’s effectiveness for rapidly reducing 
suicidal ideation and suicidal behavior when used in conjunction with outpatient mental health 
treatment. 
Cognitive processing therapy for PTSD rapidly reduces suicidal ideation. Another research gap 
identified by the PHCoE is the need for additional research focused on how diagnosis-specific 
therapies and interventions may—or may not—reduce suicidal thoughts and behaviors. Research by 
our team and others suggests PTSD treatments are associated with significant reductions in suicidal 
ideation (Brown et al., 2019, 2020; Bryan et al., 2016, 2018, 2022; Gradus et al., 2013). PTSD is a 
common mental health condition among U.S. military personnel (Tanielian et al., 2008) and significant 
risk factor for suicide. PTSD is not just a consequence of military service, however; sexual assault, 
domestic abuse, accidents, and child abuse are other common contributors to PTSD. PTSD significantly 
increases the risk of suicidal thoughts, behaviors, and death (May & Klonsky, 2016; Nock et al., 2009; 
2018) and is one of the few psychiatric conditions that distinguishes people who have attempted 
suicide from those who only thought about suicide, suggesting PTSD facilitates the transition from 
suicidal thought to action (Nock et al., 2009; May & Klonsky, 2016). Early treatment of PTSD could 
therefore reduce suicide risk in the military. Cognitive processing therapy (CPT) is a trauma-focused 
therapy that produces very large reductions in PTSD symptoms (Forbes et al., 2010; Watts et al., 2013) 
and suicidal ideation (Bryan et al., 2016; Gradus et al., 2013; Resick et al., 2017). PI Bryan has further 
shown that CPT’s effects on reducing suicidal ideation are accelerated when CPT sessions are 
scheduled daily over 2 weeks (called “massed” CPT) versus the more typical pace of scheduling sessions 
weekly over several months (Bryan et al., 2018; Sciarrino et al., 2020). Massed CPT therefore achieves 
similar reductions in suicidal ideation and PTSD symptoms within a much shorter timeframe. 
Conclusions about CPT’s effects on suicidal behavior remain unknown, however, because studies to 
date have excluded higher risk patients and/or did not enroll a large enough number of high-risk 
patients to examine suicidal behavior as an outcome. To address this critical knowledge gap, the 
proposed study will: (a) enroll only high-risk patients who report active suicidal ideation or a recent 
suicide attempt and (b) examine suicidal behavior as our primary outcome. 
2.2 RISK/BENEFIT ASSESSMENT 
2.2.1 Known Potential Risks 
• 
Emotional distress including experiencing an initial increase of PTSD symptoms and suicidal 
ideation due to the discussion of traumatic events. 
• 
Assessment and treatments may be associated with a temporary or occasional increase in 
symptoms of depression, anxiety, or other pre-existing psychiatric symptoms.  
• 
Participants may experience skin irritation from wearing the Fitbit. 
• 
Risk of breach of confidentiality while handling research data.  

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• 
One of the risks of PTSD, both in and out of treatment, is attempted suicide, which can result in 
death. 
2.2.2 Known Potential Benefits 
The main benefit to participating in this research is the receipt of high-quality, closely supervised, trauma-
focused therapy (i.e., massed CPT) and suicide risk monitoring at no cost to the participant. In addition, the 
knowledge gained from this study will serve to inform the most effective interventions for the treatment of 
elevated suicide risk among active duty service members and veterans diagnosed with PTSD. 
2.2.3 Assessment of Potential Risks and Benefits, none of which are expected to negatively affect an 
active duty participant’s fitness for duty. 
Research procedures 
Risks 
Assessments (questionnaires, 
interviews, computer testing, 
EMA, wearing the Fitbit) 
• 
Serious and likely; none 
• 
Serious and less likely; none 
• 
Serious and rare; breach of confidentiality with the use of 
online conferencing systems, handling medical and research 
records, EMA, and by the Fitabase service 
• 
Not serious and likely; discomfort, emotional distress, and a 
temporary increase in PTSD symptoms and suicidal ideation 
thinking about and completing assessments 
• 
Not serious and less likely; skin irritation from wearing the 
Fitbit  
Massed CPT 
Crisis Response Planning 
• 
May be Serious and likely; treatment can cause some 
discomfort or emotional distress and can even produce a 
temporary increase in symptoms 
• 
Serious and less likely; none 
• 
Serious and rare; breach of confidentiality with the use of 
online conferencing systems, handling medical and research 
records, and by the Fitabase service 
• 
Not serious and likely; none 
• 
Not serious and less likely; none 
3. OBJECTIVES AND ENDPOINTS 
The primary objective of this project is to determine if suicidal behaviors can be significantly reduced 
when massed CPT is enhanced with CRP. CPT is an empirically supported psychotherapy for PTSD and 
CRP is an empirically supported intervention for suicidal thoughts and behaviors. To accomplish this 
objective, we will enroll military personnel meeting diagnostic criteria for PTSD or subthreshold PTSD 
(i.e., meeting threshold levels for 3 of 4 symptom criteria) who also report active suicidal ideation within 
the past week and/or suicidal behavior within the preceding month. 
Specific Aims and Hypotheses 
Aim 1: Determine if the addition of CRP to CPT reduces suicide attempts.  
Hypothesis 1 (H1): The rate of follow-up suicidal behavior will be significantly reduced among 
military personnel receiving CRP versus usual care risk management in addition to massed CPT.  
Hypothesis 2 (H2): Reductions in the severity of suicidal ideation will be significantly larger 
among military personnel receiving CRP versus usual care risk management. 
Aim 2: Identify early markers of treatment response and relapse of suicide risk.  

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Hypothesis 3 (H3): Less severe suicide risk features during treatment will predict treatment 
response (i.e., change in severity of suicidal ideation) and treatment relapse (i.e., follow-up 
suicidal behavior). Exploratory Research Question 1 (RQ1): Which subjective, objective, and 
treatment-related factors are most useful for predicting treatment response (i.e., change in 
severity of suicidal ideation) and treatment relapse (i.e., follow-up suicidal behavior)? 
Aim 3: Identify treatment content and design features that influence treatment effectiveness and 
acceptability.  
Hypothesis 4 (H4): More frequent CRP use will be correlated with reductions in suicide attempts 
and suicidal ideation. Exploratory RQ2: Which treatment components and design features do 
participants find most helpful for reducing suicidal ideation and attempts? 
4. STUDY DESIGN 
4.1 OVERALL DESIGN 
This is a two-arm parallel randomized clinical trial comparing CRP versus CPT to usual care suicide risk 
management procedures among military personnel and veterans receiving massed CPT for PTSD.  
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Treatments that rapidly reduce suicidal ideation also reduce suicidal behaviors. Results of a previous 
RCT indicates CRP rapidly reduces suicidal ideation and suicide attempts among military personnel, but 
additional studies of CRP are needed to evaluate the intervention’s effectiveness in a broader range of 
clinical settings and populations. Pilot data collected by our team indicate that, as compared to usual care 
suicide risk management, CRP accelerates reductions in suicidal ideation and reduces suicidal behavior 
among military personnel and veterans receiving treatment for PTSD. This study will build on these 
promising findings to further test the effectiveness of CRP on suicidal ideation and suicidal behaviors 
when combined with massed CPT for PTSD. This study will also investigate early indicators of treatment 
response (i.e., reductions in suicidal ideation) and treatment relapse (i.e., suicidal behavior), thereby 
providing critical information for developing novel decision-making tools for clinicians working with 
high-risk patients. 
4.3 JUSTIFICATION FOR INTERVENTION 
CRP accelerates reductions in suicidal 
ideation and prevents suicidal behaviors 
when used in conjunction with CPT. 
Preliminary data from a pilot RCT conducted 
by PI Bryan suggests the addition of CRP to 
massed CPT leads to (a) faster and larger 
reductions in suicidal ideation among military 
personnel and veterans diagnosed with PTSD 
or subthreshold PTSD (i.e., meeting 3 of 4 
diagnostic criteria) and (b) reduces suicide 
attempts during follow-up. In that study, 74 
military personnel and veterans reporting 
active suicidal ideation within the past week 
were randomly assigned to receive massed 
CPT in conjunction with either CRP or usual 
care suicide risk management procedures (e.g., 
suicide risk screening, safety planning). As 
compared to usual care (n = 33), participants 
Figure 2. Mean suicidal ideation (log-
transformed) among military personnel and 
veterans randomized to CRP (red) or safety 
planning (blue) during massed CPT for PTSD 

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receiving CRP (n = 41) reported significantly larger reductions in suicidal ideation within 1 week 
(t(281) = 2.1, p = .041; see Figure 2), which corresponds to the midpoint of massed CPT. By 6 months, 
there were 73.2% fewer suicide attempts in the CRP group (7 attempts) versus usual care (21 
attempts), suggesting CRP also reduced suicidal behaviors. These pilot results support the feasibility of 
our proposed study and suggest CRP may be more effective than usual care suicide risk management 
strategies for rapidly reducing suicide risk among military personnel with PTSD. Though promising, 
these findings require further examination in a larger clinical trial with suicidal behavior as the primary 
outcome. 
Early reductions in suicidal ideation promote recovery from PTSD. Recent findings by our team 
further suggest that rapid reductions in suicidal ideation may also be critical for recovery from PTSD. 
Using aggregated data from multiple DoD-sponsored clinical trials testing treatments for PTSD (Brown 
et al., 2021), PI Bryan and Co-Is Peterson and Young-McCaughan found that change in suicidal ideation 
during trauma-focused therapy preceded and influenced subsequent change in PTSD symptoms among 
treatment-seeking military personnel diagnosed with PTSD. Early change in PTSD symptoms did not 
influence subsequent change in suicidal ideation, however, suggesting early reductions in suicidal 
ideation may be critical not only for preventing suicidal behavior but also for recovery from PTSD. These 
findings are currently under review for publication. Additional research focused on early markers of 
treatment response are needed, though, to confirm these promising findings. 
Early reductions in suicidal ideation promote recovery from PTSD. Recent findings by our team 
further suggest that rapid reductions in suicidal ideation may also be critical for recovery from PTSD. 
Using aggregated data from multiple DoD-sponsored clinical trials testing treatments for PTSD (Brown 
et al., 2021), PI Bryan and Co-Is Peterson and Young-McCaughan found that change in suicidal 
ideation during trauma-focused therapy preceded and influenced subsequent change in PTSD 
symptoms among treatment-seeking military personnel diagnosed with PTSD. Early change in PTSD 
symptoms did not influence subsequent change in suicidal ideation, however, suggesting early 
reductions in suicidal ideation may be critical not only for preventing suicidal behavior but also for 
recovery from PTSD. These findings are currently under review for publication. Additional research 
focused on early markers of treatment response are needed, though, to confirm these promising findings. 
4.4 END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, all treatment sessions, 28 days of EMA assessments and wearing the Fitbit, and all follow-up 
assessments.  
A treatment completer is considered to have completed 7 of the 10 (70%) of the treatment sessions.  
5. STUDY SETTING 
Participants will be seen and treated at the STRONG STAR offices, part of the Carl R. Darnall Army 
Medical Center (CRDAMC), located on Fort Hood. 
6. STUDY POPULATION 
Active duty service members and veterans at least 18 years of age seeking care for PTSD symptoms who 
have experienced active suicidal ideation within the past week and/or suicidal behavior within the 
preceding month. 
6.1 INCLUSION CRITERIA 
1. Active duty service member or veteran aged 18 or older eligible for military medical care. 
2. Able to read, write, and speak English. 

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3. Meeting diagnostic criteria for PTSD or subthreshold PTSD (i.e., meeting diagnostic threshold for 3 
of 4 symptom criteria within the past month) on the Clinician Administered PTSD Scale for DSM-5 
(CAPS-5). 
4. Active suicidal ideation within the past week as assessed by scoring ≥ 1 on Scale for Suicidal Ideation 
(SSI) item 4 (i.e., active suicidal ideation within the past month) or report an interrupted, aborted, or 
actual suicide attempt within the preceding month on the Self-Injurious Thoughts and Behaviors 
Interview-Revised (SITBI-R). 
5. Regular use of an iPhone or Android smartphone.  
6.2 EXCLUSION CRITERIA 
1. Inability to comprehend and complete the consent and baseline screening questionnaires. 
2. Current suicide or homicide risk meriting crisis intervention. 
3. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders 
warranting immediate clinical attention based on interviewer assessment and clinical judgement. 
4. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Cognitive Processing Therapy, 
Prolonged Exposure Therapy, Written Exposure Therapy). 
6.3 INCLUSION OF VULNERABLE OR SPECIAL POPULATIONS ......................................... N/A ☒ 
6.4 LIFESTYLE CONSIDERATIONS................................................................................ N/A ☒  
6.5 SCREEN FAILURES 
Participants who do not meet one or more criteria required for participating in the study will be offered 
other options for care. 
6.6 STRATEGIES FOR RECRUITMENT AND RETENTION 
The target sample size is reported in Section 1 (Study Synopsis) as well as Section 10.12 (Sample Size 
Determination). The recruitment of women and minorities is presented in Section 6 (Study Population). 
Planned Recruitment Strategies: Participants will be recruited from the Carl R. Darnall Army Medical 
Center (CRDAMC) and the Fort Hood and Killeen communities through provider referrals, recruitment 
events, flyers, study information posted on the STRONG STAR website, and social media. Interested 
individuals will be provided a consent to contact at recruitment events that allows the study staff to contact 
the potential participant. No commanders are or will be present for their service members’ medical care at 
CRDAMC. Providers can give their patients contact information for the study staff so that interested 
individuals may contact STRONG STAR directly. Alternatively, providers can provide referral information 
(e.g., patient’s name, contact information, reason for referral) to STRONG STAR study staff via encrypted 
DoD email.  
6.6.1 Costs 
There are no anticipated costs to the participants in this study other than transportation to and from the 
clinic for assessment and treatment. 
6.6.2 Compensation  
 
 
 
 
 
 
 
N/A ☐ 
• 
Participants can be compensated for completing follow-up assessments using the following 
schedule:  
o $50 for the posttreatment qualitative interview 
o $25 at 1 month 
o $25 at 3 months 
o $25 at 6 months 
o $25 at 9 months 

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o $50 at 12 months 
Participants will also be compensated for completing EMA surveys and wearing their Fitbits. 
Participants will be compensated based on the number of EMA surveys completed per week:  
o $20 per week for completing at least 75% of EMA surveys (32 of 42 surveys) and wearing 
their Fitbit at least 75% of days (5 of 7 days) per week (total $80 for the four weeks) or  
o $30 per week for completing at least 90% of EMA surveys (38 of 42 surveys) and wearing 
their Fitbit at least 90% of days (6 of 7 days) per week (total of $120 for the four weeks).  
This yields a maximum possible compensation of $120 for EMA completion and Fitbit wear, 
totaling $320 of possible compensation for all study activities. Participants will be allowed to keep 
the Fitbit. 
• 
As required by UTHSCSA, these funds will be distributed using the university ClinCard system. 
• 
Payment will be provided via a rechargeable MasterCard® ClinCard. The MasterCard® ClinCard is a 
debit card issued to the study participant. Funds are loaded onto the card through the ClinCard 
website at www.clincard.com. Only authorized users are able to access the ClinCard website with a 
username and password to add funds. The ClinCard funds will typically be available to recipients 
within one business day but payment could take up to 2 weeks. ClinCard funds can be used as the 
participant chooses. The participant will be notified that their name, social security number, address 
and date of birth will be shared with a third-party (ClinCard) for the purposes of payment processing. 
This information will be used for the administration of the payment and will be kept strictly 
confidential. 
• 
The money paid may be taxable. When the total payments from the institution accumulate to $600 or 
more in one calendar year, the institution must report the amount to the IRS. The IRS considers it 
earned income and treats it like any other income. In addition to notifying the IRS, the institution will 
also send participants a tax form that can be used when filing their personal taxes. If a participant 
chooses not to provide their SSN, ClinCard is required to withhold 24% of the payment for taxes.  
The withheld amounts may be reclaimed from the IRS when the participant files their personal taxes 
depending upon their tax situation. 
• 
In accordance with DoDI 3216.02 active duty participants will be compensated if study participation 
does not adversely impact their ability to perform their assigned duties.   
7. STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
7.1 ADMINISTRATION OF STUDY INTERVENTION(S) OR EXPERIMENTAL 
MANIPULATION(S)  
7.1.1 Study Intervention or Experimental Manipulation Description 
Participants will be randomized to receive either Massed Cognitive Processing Therapy (mCPT) + Crisis 
Response Planning (CPT) or mCPT + Treatment as Usual (TAU).   
7.1.2 Administration  
Massed Cognitive Processing Therapy (mCPT) 

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All participants will meet with their assigned research 
therapist for an initial 1½ -hour “intake” session during 
which the research therapist will provide information about 
the massed therapy protocol, schedule dates and times for 
massed CPT sessions, conduct a suicide risk assessment, and 
administer the randomly assigned suicide risk intervention. 
CPT sessions will be scheduled daily for 10 consecutive 
business days (i.e., “massed” CPT), with the first 
appointment being 1-2 weeks post-intake. The CPT session 
content is summarized in Table 1. Participants will be 
allowed to schedule up to 3 optional “booster sessions” 
during the follow-up year to review skills learned in therapy 
and receive additional support and/or coaching after the acute 
treatment phase. 
Crisis Response Planning (CRP).  
CRP entails a collaborative process wherein a suicidal person provides a narrative description of a recent 
suicidal crisis or acute period of emotional arousal then creates a plan that lists indicators of acute 
affective arousal (i.e., “warning signs”) and strategies the person could use to regulate this arousal (e.g., 
self- management strategies, reasons for living, sources of social support, professional support. With 
assistance from their research therapist, participants will handwrite a crisis response plan on an index 
card. Consistent with the intervention’s design, participants will be asked about CRP use during each 
massed CPT session as part of homework review.  
Usual Care. 
Usual care entails safety planning, a procedure that includes warning signs for a suicidal crisis; self-
management strategies; list of people, places, or events to distract from or decrease distress, contact 
information for social support; and contact information for professional resources, crisis services within 
the participant’s local community, and the Military Crisis Line. These components are handwritten on a 
pre-printed form. Safety planning is routinely administered to suicidal patients at Fort Hood as part of 
existing behavioral health services. Participants will review their safety plan with the research clinician 
during the intake session and will be directed to use it as prescribed by their military behavioral health 
clinician. 
7.1.3 Access to and Documenting Care in the Electronic Health Record   
MHS GENESIS will be accessed by a member of the research team to document the participant's care 
delivered per the study protocol and communicate with the participant’s medical care team. 
7.2 FIDELITY 
7.2.1 Interventionist Training and Tracking 
Faculty and staff providing the intervention will be required to be credentialed and privileged by 
CRDAMC or supervised by a credentialed and privileged provider prior to providing therapy at 
CRDAMC. Collaborating party staff requiring privileges will follow the Federal Laboratory’s 
requirements for requesting clinical privileges.  
Research therapists will complete standardized competency-based training in the delivery of CPT and 
CRP. The CPT curriculum includes the completion of CPTweb 2.0 online training modules available 
through the Medical University of South Carolina and a 2-day live training workshop conducted by Co-I 
Losavio and PI Bryan, two certified CPT instructors and consultants. Research therapists will also 
complete a 1-day CRP live training workshop conducted by PI Bryan, a co-developer of CRP. The 
Session No. 
Session Focus 
1 
Education about PTSD 
2 
Impact Statement #1, ABC 
3 
Challenging Quest. 
4 
Patterns of Prob. Thinking 
5 
Challenging Beliefs, Safety 
6 
Trust 
7 
Power & Control 
8 
Esteem 
9 
Intimacy 
10 
Impact Statement #2 
Table 1. Massed CPT Session Content 

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training includes didactics, case examples, demonstration videos, and opportunities for skills practice via 
role play. Research therapists will initially participate in daily clinical supervision with approved CPT and 
CRP consultants until they demonstrate protocol fidelity for a minimum of two consecutive cases. Once 
fidelity has been established, clinical supervision will be scheduled 1-2 times per week to monitor 
fidelity.  
7.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING                             N/A ☐ 
Participants meeting study inclusion and exclusion criteria will be randomized to mCPT+TAU or 
mCPT+TAU using a permuted block randomization algorithm with randomly selected block sizes. This 
algorithm increases the probability that each arm will contain an equal number of participants while 
avoiding selection bias by using random block sizes. Randomization will be supervised by the study 
biostatistician. 
 
Because participants, interventionalists, and study staff cannot be blind to the behavioral therapies being 
delivered, only the independent evaluators will be blind to the treatment condition.  
7.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE                    N/A ☐ 
Protocol fidelity will be monitored via review of audio recorded sessions using published CPT and CRP 
fidelity checklists. At the outset of the study, 100% of intake sessions and therapy sessions will be 
reviewed for fidelity. Research therapists will be required to obtain a minimum fidelity score of 85% for a 
minimum of two consecutive cases. Once fidelity has been established, 10% of intake and therapy 
sessions will be randomly selected for fidelity review to monitor fidelity throughout the study. Because 
protocol fidelity will serve as a predictor of treatment outcomes (Hypothesis 4) in this study, we will 
continue to assign cases to therapists even if they do not maintain high protocol fidelity. Therapists will 
continue to receive supervision and corrective feedback to improve fidelity, however. This approach will 
be adopted to enhance generalizability to usual care conditions. 
7.5 CONCOMITANT THERAPY                                                                                                              N/A ☐ 
Participants meeting the study inclusion/exclusion criteria and randomized to the active arm will be 
encouraged to take their prescribed medications regularly and to not start, stop, or change medications or 
medication doses if possible.  
8. DISCONTINUATION AND WITHDRAWAL  
8.1 DISCONTINUATION OF STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION 
When a participant discontinues from follow-ups, the study team will attempt to collect the following: 
• 
The reason(s) for discontinuing. 
• 
Planned follow-up assessments. 
As with all adverse event reporting, if a clinically significant finding is identified the research team 
member will bring the event to a study teleconference for adjudication and to determine if any action by 
the research team is warranted.  
8.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
• 
Participant does not meet inclusion/exclusion criteria. 

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• 
An event or medical condition or situation occurs such that continued participation would not be 
in the best interest of the participant or might require an additional treatment that would confound 
the interpretation of the study. 
• 
The participant does not follow the study procedures resulting in significant non-compliance. 
• 
Lost-to-follow up; unable to contact participant. 
• 
Participant has completed the study follow-up period. 
The reason(s) for participant discontinuation or withdrawal from the study will be recorded in the study 
database. Participants who sign the informed consent form and are randomized but who never begin the 
study intervention may be replaced. Participants who sign the informed consent form, are randomized and 
receive the study intervention but who subsequently withdraw or are discontinued from the study will not 
be replaced. 
8.3 LOST TO FOLLOW-UP                                                                                                                      N/A ☐ 
A participant will be considered lost to follow-up if he or she fails to return for scheduled visits and is 
unable to be contacted by the study site staff. The following actions will be taken if a participant fails to 
return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant and reschedule the missed visit as soon as possible 
and attempt to re-schedule the visit. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant through a combination of up to 3 telephone calls or 
text messages. These contact attempts will be documented in the participant’s study file. 
9. STUDY ASSESSMENTS AND PROCEDURES 
9.1 SCREENING PROCEDURES 
See Table in Section 1.2 (Visit Schedule Study Procedures and Assessments). 
9.1.1 Screening activities performed prior to obtaining informed consent  
Under an IRB-approved HIPAA Partial Waiver of Authorization, study personnel will conduct a brief 
discussion by in person or telephone in a private setting where the basic study inclusion and exclusion 
criteria will be reviewed to help the individual determine if he or she meets the study criteria or has 
obvious exclusions from the study protocol to prevent individuals from making unnecessary travel for 
consent and more in-depth screening. This information will be entered into a secure database as a phone 
call to a potential participant or a phone call from a potential participant: name, phone number, name of 
study the caller is interested in, referral date, referral source, potential eligibility status, reason if not 
eligible, and verbal permission to contact the caller in the future for other studies. We will also record the 
date and time of the call, outcome of the call, and any notes. Individuals who agree to study participation 
will sign a consent document before any further screening takes place. Any individually identifiable 
information and Protected Health Information (PHI) collected from individuals who do not consent to 
participation will not become part of the research data. This data will be stored in a locked file cabinet in 
the research offices (only accessible to study staff) and will be destroyed at the end of the study. If 
participants agree to participate in the research, the identifiable data collected will become part of the 
participants’ research records and will be stored according to the research confidentiality plan. 
Active duty or retired military service members who are not eligible or interested in other IRB-approved 
STRONG STAR protocols will also be told about this study. If interested, a member of the research team 
will review eligibility with these potential participants over the phone. If the person believes they may 
qualify for the study, the participant will be scheduled for an appointment in which consent will be 
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9.1.2 Screening activities performed after a consent for screening has been signed 
See Table in Section 1.2 (Visit Schedule Study Procedures and Assessments). 
9.2 STUDY EVALUATIONS & PROCEDURES 
9.2.1 Visits and Procedures 
Visits: See Table in Section 1.2 (Visit Schedule Study Procedures and Assessments) for Study Visits. 
Procedures: 
• 
Individuals referred by their provider for consideration of the study or who self-refer in response to 
study advertisements will have a brief discussion with a member of the study team where the basic 
study inclusion and exclusion criteria will be reviewed to help the individual determine if he or she 
meets the study criteria or has obvious exclusions from the study protocol so as to prevent individuals 
from taking unnecessary time for consent and more in-depth screening.  
• 
Following consent, participants will complete the baseline assessment. The baseline assessment will 
include questionnaires and interviews and will last 2-3 hours in total.  
• 
Once confirmed eligible, the participant will be randomly assigned into one of the two study arms, 
Crisis Response Planning (CRP) or Treatment as Usual (TAU). Regardless of which study arm the 
participant is randomized to, all participants will receive Massed Cognitive Processing Therapy 
(mCPT). This information will be conveyed to the participant during a 1½ -hour Intake Appointment. 
During this appointment additional questionnaires will be completed either on paper or on the 
computer. Also at this time, the participant will sync their Fitbit or a Fitbit provided by the study staff 
with Fitabase and load the EMA app onto the participant’s phone. The data collection through 
Fitabase and EMA prompts will start at this time and continue for 28 days. 
• 
CPT sessions will be scheduled daily for 10 consecutive business days (i.e., “massed” CPT), with the 
first appointment being 1-2 weeks post-intake. Participants will be allowed to schedule up to 3 
optional “booster sessions” during the follow-up year to review skills learned in therapy and receive 
additional support and/or coaching after the acute treatment. Each of the 10 treatment sessions and up 
to 3 optional booster sessions will last 1-hour.  
• 
Within 1 month of ending therapy, participants will complete one 45–60-minute semi-structured 
interview with study staff. 
• 
Follow-up assessments will be completed 4-, 13-, 26-, 39-, and 52-weeks following treatment. Each 
follow-up will last 30-45 minutes. 
Description of the Assessment Measures Administered throughout the Study. See Table in Section 1.2 
(Visit Schedule Study Procedures and Assessments) for when specific measures will be administered. 
1. Demographic and Military Service Characteristics. Participants will provide demographic 
information at their baseline assessment to include age, marital status, education, sex, and military 
service. This information will be used to compare and evaluate outcomes across participants. 
2. History of Head Injuries Questionnaire + Addendum (HHI+HHI-A). The HHI is a modified 
version of the Defense and Veterans Brain Injury Center (DVBIC) 3-Item Screening Tool (Schwab et 
al., 2007). This instrument was used as the gold standard for the diagnosis of TBI in a sample of 
soldiers returning from duty in Iraq and/or Afghanistan (Schwab et al. 2007). The HHI has been 
modified to gather information on the number of head injuries and to inquiry about any head injury 
sustained outside of deployment. 

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3. Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R_Bryan 84-CRP_TBI; Fox et 
al., 2020). The SITBI-R is a semi-structured interview assessing the presence, frequency, and 
characteristics of self-injurious and suicidal thoughts and behaviors. The SITBI-R has high interrater 
reliability, strong test-retest reliability (Fox et al., 2020; Gratch et al., 2021). The SITBI-R was 
developed from the SITBI which also demonstrated strong psychometric properties (Nock et al., 
2007). The SITBI-R consists of multiple modules assessing suicide related outcomes. Each module 
includes an initial question assessing the lifetime occurrence of the target construct (e.g., the suicidal 
ideation module asks respondents, “Have you ever had thoughts of killing yourself?”). Respondents 
who answer “Yes” to the initial question are then asked a series of quantitative and qualitative follow-
up questions. Respondents who answer No” to the gate question skip to the end of the module. The 
SITBI-R does not generate a total score. The administration takes approximately 5 to 45 minutes to 
complete, depending on the number of modules administered. This study will use selected questions 
from the SITBI-R to measure the incidence of non-suicidal self-injury, suicidal ideation, aborted and 
interrupted attempts, and suicide attempts. The interview version of the SITBI will be administered at 
baseline and at all follow-up appointments; however only 4 selected items from the interview version 
will be administered by self-report at intake, and weeks 1 and 2 assessments. 
4. Scale for Suicide Ideation (SSI; Beck et al., 1979). The Scale for Suicide Ideation (SSI) is a 19-item 
semi-structured interview that assesses the severity of suicide-related thoughts, urges, and behaviors 
(e.g., writing suicide notes) within the past week using 3-point ordinal scales. Items are summed to 
obtain an overall metric of suicide risk severity. To be eligible for this study, participants will be 
required to score ≥1 on SSI item 4, which assesses the severity of active suicidal ideation. 
5. Interpersonal Needs Questionnaire (INQ; Van Orden et al, 2012). The INQ is a self-report measure 
that assesses perceived burdensomeness and thwarted belongingness. This study will use a 5-item 
version of the INQ developed by the Military Suicide Research Consortium that showed an excellent 
internal consistency (Stanley et al., 2019). 
6. Beck Hopelessness Scale (BHS; Beck, 1974). The BHS is a self-report measure that assess 
hopelessness using a dichotomist scoring system (0 or 1). Higher scores indicated higher levels of 
hopelessness. The BHS has strong reliability and construct validity (Beck, 1974), high test-retest 
reliability (Fernandez, 1994), and good convergent validity (Steed, 2001). This study will use a 5-
item version of the BHS developed by the Military Suicide Research Consortium that (Stanley et al., 
2019) 
7. Suicide Cognition Scale-Revised (SCS-R; Bryan et al., 2022). The SCS-R is a 16-item, self-report 
measure that assesses suicide-specific thoughts and belief. The scale has demonstrated good internal 
consistency, convergent validity, and divergent validity (Bryan et al., 2014). The SCS-R evaluates 
how much an individual agrees with the suicide-related cognition. 
8. Difficulties with Emotion Regulation Scale-Short Form (DERS-SF; Kaufman et al., 2016). The 
DERS-SF is an 18-item measure created to identify emotional regulation problems. The measure 
assesses for aspects of emotional regulation and includes six subscales: nonacceptance of emotional 
responses, difficulty in goal-directed behavior, impulse control challenges, lack of emotional 
awareness, limited access to regulation strategies, and lack of emotional clarity. 
9. Monetary Choice Questionnaire (MCQ; Kirby & Maraković, 1996). The MCQ is a 27-item, self-
administered questionnaire. For each item, the participant chooses between a smaller, immediate 
monetary reward and a larger, delayed monetary reward (e.g., “Would you prefer $54 today or $80 in 
30 days?”). The protocol is scored by calculating where the respondent’s answers place them amid 
reference discounting curves, with steeper curves indicating higher levels of impulsivity. The MCQ 
has good external validity (Kirby & Maraković, 1996), as well as good internal consistency, test-
retest reliability (Duckworth & Seligman, 2005). PI Bryan has used the MCQ in multiple studies and 

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found that MCQ scores are elevated (indicating a preference for immediately available rewards) 
among adults who have recently attempted suicide.  
10. Behavioral Inhibition System / Behavioral Activation System Scale (BIS/BAS Scale; Carver & 
White, 1994). The BAS/BIS Scale is 24-item self-report assessment that measures individual 
differences in motivation. PI Bryan has used the BIS/BAS Scale in several ongoing research studies 
and has found that suicide attempts are significantly elevated among adults who score high on both 
subscales. The BIS/BAS Scale has demonstrated good convergent and discriminant validity, 
reliability, and test-retest reliability (Carver & White, 1994).  
11. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) with the Selection of Index Events 
(SOIE). The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD (Weathers et 
al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 
(Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 
symptoms. Additional items that are not included in the total score evaluate overall symptom 
duration, distress, impairment, dissociative symptoms, and global ratings by the interviewer. 
Validation studies are nearly complete to establish the psychometric properties of the CAPS-5 and 
findings will be reported in peer-reviewed publications. Subscale scores are calculated by summing 
severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, 
negative alterations in cognitions and mood, and hyperarousal. The Selection of Index Event is a 
semi-structured questionnaire was developed by the STRONG STAR Consortium. It is designed to 
assist participants in identifying their most distressing traumatic experience, for the focus of further 
assessment and treatment. It will be used in this study, in conjunction with the CAPS-5, to assist in 
the assessment of PTSD symptoms. 
12. Life Events Checklist (LEC). Life Events Checklist for DSM-5 (LEC-5; Weathers, Blake, et al., 
2013) includes a list of 16 potentially traumatic life events commonly associated with PTSD 
symptoms, along with an additional item (17) that allows respondents to describe any other stressful 
events or experience. The STRONG STAR Consortium included two additional items that screen for 
military sexual trauma, which are also used by the VA to assess for uninvited and unwanted sexual 
attention as well as sexual assault. A final item asks the participant to consider what they consider 
their “worst event.” For each potentially traumatic life event, respondents rate their experience of that 
event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part 
of my job, 5 = not sure, and 6 = doesn’t apply). The LEC-5 has demonstrated desirable levels of test-
retest reliability when utilized as a cumulative trauma measure to assess for varying types of 
traumatic experiences (e.g., direct experience of trauma, witnessing trauma, etc.; Pugach et al., 2021). 
13. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013). The PCL-
5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. The 
PCL-5 evaluates how much participants have been bothered by PTSD symptoms as a result of a 
specific life event. Each item of the PCL-5 is scored on a 5-point scale ranging from 0 (not at all) to 4 
(extremely). The PCL has excellent psychometric characteristics for screening and as a secondary 
indicator of PTSD symptom severity (see McDonald & Calhoun, 2010). The PCL-5 has also 
demonstrated excellent internal consistency (α = .96), as well as convergent and discriminant validity 
(Bovin et al., 2016). The PCL-5 also has strong test-retest reliability (Blevins et al, 2015). 
14. Posttraumatic Cognitions Inventory-9 (PTCI-9; Wells et al., 2019). Trauma-related beliefs will be 
assessed using the shortened version of the Posttraumatic Cognitions Inventory (PTCI), which is a self-
report scale that assesses negative beliefs about the self, others, and the world stemming from one’s 
trauma. 

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15. Satisfaction with Therapy and Therapist Scale – Revised (STTS-R; Oei & Green, 2008). The STTS-
R (Oei & Green, 2008) is a 12-item self-report measure with strong psychometric properties used to 
assess the patient’s satisfaction with the therapy provided and the therapist. Even number items assess 
satisfaction with therapy and odd number items assess satisfaction with therapist. Higher scores are 
reflective of greater satisfaction. Items are on a 5-point Likert scale that ranges from 1 = “Strong 
disagree” to 5 = “Strongly Agree’. Additionally, a 13th item provides an independent assessment of 
the patient's global improvement. 
16. The Cornell Services Index – Short Form (CSI-SF; Sirey et al., 2005) is a brief assessment tool that 
measures service utilization across medical, mental health, social support domains. It helps identify 
care patterns, service gaps, and overall service impact, making it useful for research, clinical 
assessments, and program evaluations. 
17. PROMIS Computer Adaptive Tests (PROMIS-CATs; Segawa et al., 2020). Mental health symptoms 
(e.g., depression, anxiety, insomnia) and quality of life will be assessed using PROMIS Computer 
Adaptive Tests (PROMIS- CATs) in REDCap. Please note that while all of the possible PROMIS-
CATs questions are being submitted for regulatory reviews, the actual number of questions 
participants respond to will be less based on the PROMIS-CATs adaptive testing algorithm.  
18. Clinical Global Impression (CGI; Busner & Targum, 2007). The Clinical Global Impression (CGI) 
scale is a measure developed for clinical trials to provide a brief assessment of the clinician’s view of 
a patient’s functioning prior to and after initiating a study treatment. The CGI provides an overall 
summary measure that considers knowledge of the patient’s history, psychosocial circumstances, 
symptoms, behaviors, and life functioning. The CGI involves two 7-point items that evaluate (a) the 
severity of a participant’s psychopathology and (a) change from the start of treatment. This study will 
only use the improvement scale.  
19. Ecological Momentary Assessment (EMA). This study will utilize EMA to assess participants’ 
behaviors, mood, and social context in real time in participants’ natural environments. Positive and 
negative mood state will be assessed using 15 items to assess affect, some drawn from the Positive 
and Negative Affects Scale (PANAS; Watson et al., 1988). Social context will include researcher-
developed items to assess who participants are with and perceived closeness to other people. Suicidal 
ideation will be assessed using a sum score of items assessing various facets of ideation including 
wish to live, wish to die, suicidal intent, feeling that life is not worth living, and thoughts about 
suicide. Consistent with best-practice recommendations (Conner & Lehman, 2012), we will employ a 
mixture of fixed time-based sampling and experience sampling. A fixed time-based survey will be 
administered every morning to assess the occurrence of variables during the preceding night or prior 
day, and experience sampling will be used to deliver five standardized surveys, distributed quasi-
randomly during each day (<5 minutes to complete). The protocol for these prompts draws from 
items from a battery that measures: 1) select items assessing current positive and negative affect and 
rumination; 2) items measuring suicidal ideation and behavior; 3) items measuring substance use; 4) 
behavioral and contextual factors that can impact risk/resilience for our outcomes of interest (i.e., 
stressful situations, social engagement), 5) sleep characteristics, and 6) crisis response plan use. 
Please note that while all of the possible 96 questions are being submitted for regulatory reviews, a 
selection of questions 1-50 will be administered each morning during EMA and a selection of 
questions 1-46 (starting on page 7) will be administered the other times throughout the day. 
Participants will respond to EMA prompts through their smartphone. Participants will be trained to 
complete the EMA procedures by study staff who will lead participants through a training demo to 
ensure that participants understand how and when to answer questions through EMA. EMA prompts 
will be randomly delivered throughout the day, with no scheduled differences between weekend and 
weekday prompts. To offset participant reactivity, question sets will be administered in a random 

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order each day. These procedures are in line with those currently of DoD-funded EMA research of 
CRP (W81XWH-22-2-0072; PI Bryan, Co-I Khazem). 
EMA is administered through the HIPAA certified MetricWire system, which provides a cross-
platform (iOS and Android) application for the delivery of EMA surveys and collection of phone 
sensor data. EMA data will be collected for approximately a 4-week EMA period. The MetricWire 
system has been enhanced to comprehensively collect and analyze participant interaction data through 
various phone sensors, ensuring privacy and battery conservation. As part of the Intake Interview, 
participants will be instructed how to set up, log into, and manage their MetricWire account on their 
smart phone. The participant will enter their email address to activate their account. No PHI is 
maintained by the MetricWire. Question prompts are sent out by MetricWire and the participant’s 
responses are linked to the participant via their study ID number which The OSU collaborators will 
download for analysis. All EMA prompts contain an integrated safety protocol to direct participants 
to their treatment team and/or emergency services should we identify suicide risk during momentary 
assessments. See Section 9.3 (Safety Assessments) below for details. 
20. Fitbit. Fitbit Inspire HR will measure heart rate, physical activity, and nighttime wakefulness. Fitbit 
has psychometric validation for assessing each of these constructs (Wallen et al., 2016). Fitbit data 
will be collected through Fitabase, HIPAA-compliant software. This product collects Fitbit data 
(connected to an identification number) in real-time and makes it accessible to the research team for 
continual monitoring. Fitabase provides more fine-grained detail about the data than is typically 
provided through Fitbit. 
21. Qualitative Interviews. Within 1 month of ending therapy, participants will complete one 45–60-
minute semi-structured interview with study staff, which will be recorded and later transcribed for 
data analysis. Sample interview questions are listed below and will focus on participants’ treatment 
experiences, strategies for coping with suicidal thoughts, and treatment acceptability.  
 
Sample qualitative interview questions 
Treatment Experiences 
What part of the treatment do you think helped you the most? How 
so? 
Was there a time during treatment where it “clicked” or you felt 
more comfortable with the materials and understanding? 
Coping with Suicidal 
Thoughts 
What skills, if any, have you learned from your treatment to cope 
with suicidal thoughts? 
Was there a time when you considered discussing your suicidal 
ideation, plans, or attempts, during CPT treatment and decided not 
to? If yes, what stopped you from discussing them? If no, what 
made you comfortable enough to discuss them? 
Treatment Acceptability 
What parts of treatment do you think you will retain in your day-to-
day life after ending? Are there parts that you will not continue? 
Would you recommend this treatment to other service members 
experiencing similar difficulties? Why or why not? 
 
Interviews will be conducted virtually using a HIPAA-compliant video-based communication 
platform and will be recorded using the system’s automated transcription feature. Interview 
recordings and associated transcripts will be saved on the encrypted study database server at 
UTHSCSA that is only accessible to IRB-approved members of the study team. A member of the 
study team will review the transcriptions for accuracy and to remove any identifying information so 
that the transcriptions are de-identified. 
 

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Content Coding of the Transcribed Interviews: We will use interpretative phenomenological 
analysis,63,64 a qualitative, thematic approach which fundamentally acknowledges phenomenological, 
hermeneutic, and idiographic principles in the development and interpretation of one’s subjective, 
lived experience and has been extensively  used  in  healthcare  and  in  the examination of chronic 
illness and pain.65,66 NVivo, a qualitative analysis software platform that allows researchers to 
organize, and assign attributes to data for comparative purposes will be used to assist the researchers  
code and categorize the text into personal experiential themes and then into group experiential themes 
across participants using interpretative phenomenological analysis. No data are stored in NVivo, 
rather it is a tool to facilitate the qualitative analysis of research interview data. 
9.2.1 BIOSPECIMEN EVALUATIONS                                                                                                     N/A ☒ 
9.2.2 SAMPLES FOR GENETIC/GENOMIC ANALYSIS                                                                    N/A ☒ 
9.3 SAFETY ASSESSMENTS                                                                                                                      N/A ☐ 
Study assessments that will be done to ensure inclusion and exclusion criteria are outlined as part of the 
inclusion and exclusion criteria in Section 6 (Study Population) and Section 9 (Study Assessments and 
Procedures). 
Baseline suicide-specific measures are reviewed by a member of the study staff to determine if any 
additional assessment or intervention is warranted.  
Safety Assessment Specific to EMA: Participants will be instructed to complete the EMA surveys in a 
safe place and during a time when they can briefly (< 5 minutes) stop what they are doing to answer the 
EMA questions. Participants will have up to an hour to respond to the questions to allow them time to 
respond to the EMA prompts in a safe place. 
Risk of suicide might be a concern for some participants. Although suicidal ideation is a risk factor for 
suicidal behavior, most people who think about suicide do not act on these thoughts. Additionally, studies 
have demonstrated that repeated assessment does not cause or lead to suicidal thoughts/behaviors. As 
such, the current protocol itself is not likely to increase participant’s risk for suicide. Nonetheless, suicide 
risk might naturally change throughout the course of the study, and we have developed a detailed protocol 
to address safety concerns that might arise. For suicidality reported during EMA prompts, our research 
team has successfully conducted a number of studies assessing suicidality via EMA among high-risk 
patients, including both adolescents and adults.  
The following procedures were developed in collaboration with the National Institute of Mental Health 
(NIMH) and have been successfully used by our team and collaborators to manage suicide risk identified 
via EMA. We will not actively monitor EMA data for suicide content for several reasons: 1) Any one 
instance of elevated suicidal ideation or behavior is unlikely to predict a future death by suicide. 
Intervention in this context might result in unnecessary psychiatric hospitalization, loss of freedom or 
employment due to unexcused work absence for our participants, or violation of privacy. In the most 
extreme of cases, unnecessary intervention can result in physical harm or death to the patient (i.e., 
combative interactions with first responders). 2) For a small subset of our sample, the presence of suicidal 
ideation may be frequent and chronic, and reacting to each instance would be clinically 
counterproductive. 3) As this study is designed in part to identify novel risk factors for suicide, 
intervention in the presence an instance of elevated suicidal ideation or behavior will alter the nature of 
the study, making it much more difficult to achieve our study goals.  
The need to protect participant safety must be balanced against the statistically unlikely event of a death 
by suicide, the inherent risk of overreacting and unnecessarily harming or inconveniencing our 
participants, and the effect of increased contact with participants on study aims. Consequently, all 
participants will be explicitly instructed during the app training that no one will be monitoring data 

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collected from the mobile app in real-time and will be provided instead with resources if they indicate 
suicide risk (threshold criteria described below): National Suicide Prevention Lifeline (Call or Text): 9-8-
8); For emergencies, call 9-1-1 and ask for a CIT (Crisis Intervention Team)] Officer. All participants are 
provided with an EMA survey that can be accessed ‘on demand’ that contains a list of mental health 
resources, including the suicide prevention hotline, should they experience a crisis or desire assistance 
during periods when they are not responding to EMA prompts.  
If, during the course of an EMA survey, a participant “flags” as being at current high risk for suicide, they 
are directed within the survey to a “we are concerned about you” message. This message will contain 
information expressing concern about the participant’s wellbeing, remind the participant that EMA 
responses are not actively monitored by the research team, and provide resources for the participant to 
reach out to for help (including the suicide prevention hotline and information about nearby emergency 
resources). The following criteria will be used to flag the “we care are concerned about you” message: 
Suicidal intent: defined as a score of 3 or higher (range 0-4) on the suicidal intent item, “how sure are you 
that you want to kill yourself?”; Suicidal Behavior: defined as a positive endorsement of the item, “have 
you done anything to hurt yourself with at least some intent or desire to die?” or selected any suicide-
related behavior from the item, “In the past 2 hours, have you done any of the following.” See 
Appendices for the EMA MetricWire “we are concerned about you” Message. 
All interview measures as well as indicated safety assessments will be performed by qualified personnel. 
For this study, all Adverse Events Documents collected on patients for this protocol will be reviewed by 
the PIs at least monthly to determine if a serious safety problem has emerged that result in a change or 
early termination of the protocol such as: 
• 
suspending enrollment due to safety or efficacy, or 
• 
termination of the study due to a significant change in risks or benefits.   
Any protocol modifications, problematic safety reports, unanticipated problems, and/or suspension or 
early termination of a study will be reported to all members of the research team, the UTHSCSA IRB, the 
CRDAMC Human Protections Director, the STRONG STAR Data Safety Monitoring Board (DSMB), 
the sponsor, and the funder according to each’s policies and guidance. Suspension and early termination 
of a study will be reported immediately to the STRONG STAR Data Safety Monitoring Board (DSMB), 
the sponsor, and the funder. 
9.4 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS.  
Adverse Event definition: An adverse event (AE) is defined as any untoward or unfavorable medical 
occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory 
finding), symptom, or disease, that is a change from baseline, whether or not considered related to the 
subject’s participation in the research.  For this study, all adverse events will be documented at each study 
visit and be completed with the last study visit. Serious Adverse Event definition: A serious adverse event 
(SAE) is any adverse event that: 
1. results in death; 
2. is life-threatening (places the subject at immediate risk of death from the event as it occurred); 
3. results in inpatient hospitalization or prolongation of existing hospitalization; 
4. results in a persistent or significant disability/incapacity; 
5. results in a congenital anomaly/birth defect; or 
6. based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical 
or surgical intervention to prevent one of the other outcomes listed in this definition. 
9.5 UNANTICIPATED PROBLEMS  

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Unanticipated Problem Involving Risks to Subjects or Others definition: Unanticipated problem involving 
risk to subjects or others includes any incident, experience or outcome that meets all of the following 
criteria: 
A. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the subject population being studied; 
and 
B. definitely related or probably related to participation in the research; and 
C. suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
9.6 REPORTING OF PREGNANCY                                                                                                        N/A ☒ 
10. STATISTICAL CONSIDERATIONS 
10.1 STATISTICAL HYPOTHESIS 
Aim 1: Determine if the addition of CRP to CPT reduces suicide attempts.  
Hypothesis 1 (H1): The rate of follow-up suicidal behavior will be significantly reduced among 
military personnel receiving CRP versus usual care risk management in addition to massed CPT.  
Hypothesis 2 (H2): Reductions in the severity of suicidal ideation will be significantly larger 
among military personnel receiving CRP versus usual care risk management. 
Aim 2: Identify early markers of treatment response and relapse of suicide risk.  
Hypothesis 3 (H3): Less severe suicide risk features during treatment will predict treatment 
response (i.e., change in severity of suicidal ideation) and treatment relapse (i.e., follow-up 
suicidal behavior). Exploratory Research Question 1 (RQ1): Which subjective, objective, and 
treatment-related factors are most useful for predicting treatment response (i.e., change in 
severity of suicidal ideation) and treatment relapse (i.e., follow-up suicidal behavior)? 
Aim 3: Identify treatment content and design features that influence treatment effectiveness and 
acceptability.  
Hypothesis 4 (H4): More frequent CRP use will be correlated with reductions in suicide attempts 
and suicidal ideation. Exploratory RQ2: Which treatment components and design features do 
participants find most helpful for reducing suicidal ideation and attempts? 
10.2 SAMPLE SIZE DETERMINATION 
See Power and sample size calculations in Section 10.4.2 (Analysis of the Primary Endpoints) below. 
10.3 POPULATIONS FOR ANALYSES 
Data collected from all participants will be included for analysis. Comparisons will be made to 
determine differences in outcome measures between the intervention groups. 
10.4 STATISTICAL ANALYSES 
10.4.1 General Approach 
Prior to statistical analyses, data will be screened to assess the need for scale transformations (e.g., log, 
reciprocal) to normalize distributions or reduce variance heterogeneity. The study design is a two-arm 
randomized clinical trial with a superiority hypothesis (i.e., CRP superior to usual care). Analyses will 
use survival analysis and mixed effects regression with repeated measures. Follow-up assessment data 
will be collected from participants even if they drop out of therapy early. The primary focus will be on 

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group differences over time. All hypotheses will be two-sided at the α=.05 level. Little’s MCAR test 
will be used to determine if data are missing at random (Li, 2013; Little et al., 2002) and random 
effects pattern-mixture modeling will be used to determine if missingness influences longitudinal 
results (Hedeker & Gibbons, 1997; Little, 1993). The principal statistical software to be used is SAS 
9.4 supplemented with SPSS, R, and MPlus. 
10.4.2 Analysis of the Primary Endpoints 
Hypothesis 1: The rate of follow-up suicidal behavior will be significantly reduced among military 
personnel receiving CRP versus usual care risk management in addition to massed CPT. 
Survival analysis with time-to-suicide attempt will be used to test overall differences between the two 
intervention groups. We will use the hazard ratio derived from the Cox regression supplemented with the 
log-rank and Wilcoxon statistics derived from the Kaplan-Meier method. Time will be calculated as 
number of days since the intake appointment. Multiple suicide attempts within participants will be 
handled using the Andersen-Gill counting process model (Anderson & Gill, 1982), which assumes that 
the time increments between multiple suicide attempts can be explained by past suicide attempts (e.g., 
shorter time intervals between suicide attempts are more likely among patients who have previously 
attempted suicide). Power Analysis: Power calculations for H1 were conducted using PROC POWER in 
the SAS 9.4 software. Anticipated suicide attempt rates were based on previously published clinical trials 
conducted within and external to the military. In previous studies of cognitive behavioral therapies for 
suicide prevention, the suicide attempt rate in the usual care conditions often ranges from 40-50% during 
the first year and active suicide-focused interventions typically have 50% lower suicide attempt rates 
(Brown et al., 2005; Gysin-Maillart et al., 2016; Linehan et al.., 1991; Rudd et al., 2015). In our previous 
RCT of CRP versus usual care (Bryan et al., 2017), participants receiving CRP were 76% less likely to 
attempt suicide. Results of our pilot study of massed CPT yielded a similar 73% reduction in suicide 
attempts in the CRP group versus usual care. We therefore estimated statistical power for hazard ratios 
ranging from 0.50-0.75 when suicide attempt rates in usual care ranged from 30-50%, assuming 15% 
attrition, 1-year follow-up, and a two-tailed p<.05. N=150 yielded >80% power under nearly all 
conditions. 
 
Hypothesis 2: Reductions in the severity of suicidal ideation will be significantly larger among military 
personnel receiving CRP versus usual care risk management. 
Mixed effects regression models with repeated measures will be used to test group differences in suicidal 
ideation over time. Treatment group, time, and the treatment*time interaction will be entered as 
independent variables and SSI scores as the outcome. Random intercepts and slopes will be tested, and 
covariance structures will be selected by comparison of likelihood criteria (e.g., Akaike’s Information 
Criteria). Group differences in mean SSI scores will be probed at 2, 4, 13, 26, 39, and 52 weeks, with 
the largest differences between groups expected to occur at 2 and 4 weeks. Consistent with these 
expectations, we will also compare the SSI slopes from baseline to session 5 (treatment midpoint) and 
session 10 (treatment end) to determine if the rate of change in suicidal ideation differs across groups. 
Power Analysis: We used the General Linear Mixed Model Power and Sample Size (GLIMMPSE) 
software to calculate power for H2 using data from our pilot study to estimate SSI mean differences 
between groups at baseline (Mdiff=0), treatment midpoint (Mdiff=4), and treatment end (Mdiff=2) 
assuming a two-tailed p<.05. Results indicated N=150 provided 81% power. 
 
Hypothesis 3: Less severe suicide risk features during treatment will predict treatment response (i.e., 
change in severity of suicidal ideation) and treatment relapse (i.e., follow-up suicidal behavior). 
For H3, we will use suicidal ideation EMA ratings collected during the 2 weeks of massed CPT. We will 
first calculate the following indices of change in suicidal ideation during the entire 2-week observation 

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window (up to 42 EMA surveys per participant) for each participant: stability (i.e., the autocorrelation of 
scores over time), severity (i.e., mean score across all responses), and variability (i.e., the root mean 
square successive difference [RMSSD] across all responses). Each change index will be entered as an 
independent variable into a linear regression model predicting pre-post change in SSI score and a binary 
logistic regression model predicting follow- up suicidal behavior. To evaluate the specificity of these 
findings to the two weeks of active treatment, we will expand these analyses to include all 5 weeks of 
planned EMA data collection (i.e., 1 week prior to treatment start, 2 weeks of treatment, 2 weeks after 
treatment completion). This approach will allow us to distinguish treatment- specific patterns from more 
general patterns that signal treatment response and treatment relapse. Power Analysis: Power 
calculations for H3 were conducted using G*Power 3.1.9.2 (for suicidal ideation) and PROC POWER in 
the SAS 9.4 software (for suicide attempts). For the linear regression model, N=150 yielded 80% power 
to detect a medium effect (R2=0.06) and for the binary logistic regression, N=150 provided >80% power 
to detect an odds ratio=1.5, assuming a conservative 20% of participants attempts suicide during follow-
up. 
 
Exploratory Research Question 1: Which subjective, objective, and treatment-related factors are most 
useful for predicting treatment response (i.e., change in severity of suicidal ideation) and treatment relapse 
(i.e., follow- up suicidal behavior)? 
We will use the same analytic approach described for H3 but extend the analyses to all other variables 
assessed via EMA (i.e., positive and negative affect, negative thinking, and maladaptive behaviors) and 
Fitbit (i.e., physical activity, sleep quality). We will construct a series of models to determine which 
variables (and combination of variables) maximize the variance explained in pre-post change in SSI score 
and follow-up suicidal behavior. Power Analysis: Power calculations for RQ1 were conducted using 
G*Power 3.1.9.2. Assuming our model includes no more than 6 predictor variables, N=150 yielded 80% 
power to detect R2 increases of 0.06-0.08 associated with each additional predictor variable. 
 
Hypothesis 4: More frequent CRP use will be correlated with reductions in suicide attempts and suicidal 
ideation. 
We will sum the number of EMA responses during which participants endorsed the use of their CRP (and 
safety plan), such that higher values indicate more frequent intervention use. This count variable will be 
entered into a Cox regression model predicting time to suicide attempt and a linear regression model 
predicting change in SSI score to assess the correlation of intervention use with, respectively, follow-up 
suicidal behavior and severity of suicidal ideation. We will construct separate models or each treatment 
group. To test the specificity of our findings to CRP, we will repeat these analyses with CPT homework 
completion, also assessed during EMA and calculated as the sum of positively endorsed EMA responses, 
entered as a covariate. Power Analysis: The power analysis for H4 mirrors the power analysis for H3 
above. 
Exploratory Research Question 2: Which treatment components and design features do participants 
find most helpful for reducing suicidal ideation and attempts? 
We will use descriptive statistics of participant characteristics, chi-squared tests, and Pearson correlations 
(where applicable) to explore relationships among personal experiential themes, group experiential 
themes , and participant characteristics. Power Analysis: Recommendations for minimum sample size in 
qualitative studies using IPA typically range from 2-25 participants, depending on the homogeneity that 
exists within participants’ lived experience (Alase, 2017; Smith et al., 1999). Because we plan to 
interview all enrolled participants, our sample size will be more than adequate. 
10.4.3 Analysis of the Secondary Endpoint(s)  
See Section 10.4.2 (Analysis of the Primary Endpoints) for the analysis plan for each of the study aims. 

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10.4.4 Safety Analyses                                                                                                         
Not applicable. 
10.4.5 Baseline Descriptive Statistics 
Section Demographic and military service demographics will be presented. Appropriate statistical tests 
for categorical and continuous data will be calculated. 
10.4.6 Sub-Group Analyses                                                                                                   
See Section 10.4.2 (Analysis of the Primary Endpoints) for the analysis plan for each of the study aims. 
10.4.7 Tabulation of individual Participant Data                                                               
Not applicable, individual participant data will not be listed by measure or time point. 
11. REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
11.1 INFORMED CONSENT PROCESS 
11.1.1 Consent/Assent Procedures and Documentation 
During the consent appointment, potential participants will have the study explained to them in a private 
location in-person, by phone, or by video teleconference (using a secure video teleconferencing platform) 
using a paper form, mailing or emailing electronic consent documents to potential participants, or 
electronic consent (using online eConsent built in the UTHSCSA REDCap) on Fort Hood at the 
designated STRONG STAR offices in the Shoemaker Center. The potential participant will be sent a link 
to the eConsent and/or mailed (electronically or by post) and/or given a copy of the informed consent 
document (ICD) to read. After the potential participant has read the ICD, and a member of the study team 
has reviewed the risks and benefits of the study to ensure the participant understands the research, the 
participant will be given the opportunity to discuss the research with family and friends. The research 
team will be available to answer any questions about the research on the phone, in-person or using a 
HIPAA-compliant telehealth platform. Once the potential participant has reached a decision, the 
participant will sign the consent form either electronically or on a paper form. A copy of the ICD will be 
given to the participant. Additionally, as noted in the informed consent document, the Fitabase Terms of 
use (https://www.fitabase.com/terms) and the Fitabase Privacy Policy (https://www.fitabase.com/privacy) 
will be provided to the potential participant to read and review.  
Following consent, participants will have the option of receiving text messages and phone calls using a 
study cell phone to remind them of upcoming study appointments as is usual practice by CRDAMC. 
 
As described in the consent, participants on active duty will have the option of having their Command or 
employer notified by the Research Staff to ensure active duty service members and veterans are afforded 
the time to participate in the study. Command or employer agreement to allow for duty time to participate 
in this study is not a requirement for study participation. 
11.1.2 Consent for minors when they teach the age of majority 
 
     
N/A ☒ 
11.1.3 Consent of Subjects who are, or become, decisionally impaired 
             N/A ☐ 
Adults unable to provide consent are excluded from enrolling in the protocol. Adults who become 
decisionally impaired during study participation will be excluded from the study and the team will 
coordinate to refer for appropriate care.     
11.2 STUDY DISCONTINUATION AND CLOSURE 

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The study may be discontinued and/or closed based on the PI decision, sponsor/funder decision, 
regulatory or other oversight bodies’ review of serious, unexpected, and/or related AEs, noncompliance, 
and/or futility. 
11.3 CONFIDENTIALITY AND PRIVACY  
Confidentiality of Study Data: Data will be stored by an assigned participant code number so that data 
records can be viewed only by password-authenticated, authorized investigators and study personnel. All 
assessment and CRP sessions will be audio-recorded. Recordings will be labeled with the participant’s 
study id number and will be stored in the STRONG STAR database until the end of the study. Audio 
recordings will be stored in the STRONG STAR Repository at the end of the study. 
REDCap and/or the STRONG STAR eCAP online data capture system will be used for data collection 
and monitoring. The REDCap (Research Electronic Data Capture) platform is a HIPAA-secure data 
management system. REDCap provides audit trails for tracking data changes and maintains a secure 
environment for data storage, reducing the risk of data breaches. Emails and mobile phone texts will be 
sent to participants with a survey link, username, and password. Survey data will be transmitted to the 
REDCap server using an encrypted, secured link and stored at UTHSCSA on password-protected 
computers and secured cloud storage. The STRONG STAR password protected database is housed on a 
secure UTHSCSA server (physically located at the Advanced Data Center; ADC) by a member of the 
research team. Electronic data will be stored and managed by the STRONG STAR Data Management 
Core staff. If needed, the overall PI and named collaborators will have access to identifiable data as 
agreed to by participants through the signed HIPAA authorization through the STRONG STAR website 
and UTHSCSA server. All UTHSCSA STRONG STAR network connectivity is segmented with Access 
Control Lists and is not accessible to any other UTHSCSA network segments. The ADC has 24x7 onsite 
security, card key, biometric access controls and video surveillance. UTHSCSA ADC facility also 
maintains Gen 2 firewall devices to protect and prohibit any unauthorized physical or electronic access to 
UTHSCSA data. All UTHSCSA network devices are monitored by state of the art monitoring 
applications that include configuration audit, management, and availability 24x7. The UTHSCSA 
STRONG STAR data server is currently a VMware Instance running Windows Server 2016 Enterprise 
Standard with daily backup services and vSphere Business Continuity Advanced Failover. 
EMA is administered through the HIPAA compliant MetricWire system, which provides a cross-platform 
(iOS and Android) application for the delivery of EMA surveys and collection of phone sensor data. 
EMA data will be collected over a 4-week period. Data will be identified on MetricWire using the 
participants identification number. Data are stored on the Metricwire cloud servers accessible only to 
authorized study staff. Data will be downloaded from MetricWire into an Excel or CSV file and uploaded 
to the study database for analysis. 
Access to Study Data: Every member of the Research Team will be trained and monitored about how to 
handle and protect both medical and research records. Furthermore, the Research Team strictly controls 
access to study data. Only select STRONG STAR Data Core personnel have direct access to the data on a 
“need to access basis.” Data Core also follows the Principals Of Least Privilege (POLP). For example 
(but not limited to) detecting and repairing data corruption and producing reports not currently within the 
STRONG STAR system. All user activity is tracked and recorded within the system so if any records are 
added, altered or viewed the action is recorded and can be recalled for auditing purposes. Access to this 
information will require a password-protected login available only to authorized STRONG STAR Data 
Core staff.   
Research staff can enter and view data only through use of the web-based database management software 
interfaces. These display data only to appropriate personnel with logon privileges for delimited purposes. 
The database maintains a table of authorized users. Users are individually assigned a role within the 
application that specifies privileges for that user. Logins to data websites and databases are password 

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protected. All applications can be independently configured to perform specific tasks and utilize 
customer-specific security models, database connection schemes, and resources based on such roles.   
Every member of the research team will be trained and supervised about how to handle and protect both 
medical and research records.  Furthermore, the research team strictly controls access to study data. 
Limits of Confidentiality: Complete confidentiality cannot be promised for military personnel because 
information regarding the service member’s health may be required to be reported to appropriate medical 
or command authorities to ensure the proper execution of the military mission, including evaluation of 
fitness for duty. Based on the screening and testing done in the conduct of this research, the team may 
find out that participants are having unusual mental health symptoms, are consuming dangerous amounts 
of alcohol, or are feeling like hurting themselves or others. The research team will work with participants 
to get them the care they need. This care may result in the military revoking participant’s clearances, 
credentials, or other privileged access or duty. Furthermore, suspected or known abuse or neglect of a 
child, a disabled person, or an elder or threatened violence to themselves or others must and will be 
reported to appropriate authorities in accordance with state law. There are other local health-reporting 
requirements that need to be reported. 
Data from the Fitbit will be collected using Fitabase, https://www.fitabase.com/, a data management 
platform designed to support research projects using wearable and internet-connected devices.  As 
described on the Fitabase website, https://www.fitabase.com/resources/knowledge-base/working-with-
the-irb/, for collection of the activity data from the Fitbit, a research staff member will create a unique 
email and password combination in order to create an account on Fitbit.com.  The following information 
will be entered: 
• 
First & Last Name: A de-identified placeholder name. 
• 
Date of Birth: The first day of the month of birth. 
• 
 Sex: The participant's biological sex.  
• 
Height: The participant's height. 
• 
Weight: The participant's weight. 
These personal demographic details (i.e., date of birth, sex, height, and weight) are required for accurate 
estimation of data captured by the Fitbit Device. The Fitbit account will be connected to a research device 
or to the participant’s own personal Fitbit if they use a Fitbit Inspire. Once the device is connected to the 
study-generated and study-controlled Fitbit account it will be manually connected to the Fitabase platform 
and assigned a unique study ID so that data will be synced and available for viewing and downloading by 
research staff. All data associated with the Fitbit device will be linked to the study ID in the Fitabase 
platform.  Participants will be given the connected Fitbit device and be provided with the associated 
email/password so that they may login into the Fitbit.com user account, use the online Fitbit dashboard, 
and associated mobile applications. They will be informed that research staff will be able to access, view, 
and download their data through the Fitabase platform.  
The research team will set up a study project within the Fitabase system for generating unique identifiers 
and connecting participants’ Fitbit devices to the Fitabase system. When an authorized member of the 
research team logs into the Fitabase system they will be able to see all currently connected devices and 
the associated study IDs. Each study identifier has a profile that includes the Fitbit data described in the 
consent documents. Upon authorization by the PI or participant the Fitabase system will be granted access 
data gathered by the participant as they use the Fitbit device during the data collection timeframe as 
described in the consent documents. When the data has been downloaded to Fitabase, a member of the 
research team will navigate to the participant’s profile and download CSV (comma separated value) files 
that contain sleep data to the secure lab server. No other data will be downloaded. Once the study has 
been completed and the data has been downloaded and scanned for errors, the participant’s profile will be 
deleted and the authorization will be removed. The Fitabase data security and privacy practices and 

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policies are described at https://www.fitabase.com/resources/knowledge-base/working-with-the-irb/data-
security-privacy/.   
Privacy Measures. All study activities will occur in a private room or using secure telecommunication 
means. 
Sensitive Information: UTHSCSA STRONG STAR research staff will be trained to evaluate research 
participants and assess risk of harm to self, others, and military mission. Sensitive information will be 
reported according to federal, Department of Defense, and state code regulation. Telephone-based 
contacts will only occur using secure telehealth platforms or landlines to ensure privacy during telephone-
based assessment. Assessors will be trained in privacy practices and calls will only take place with 
participant consent. Calls will originate from a private room or office at CRDAMC. Procedures for 
telephone contact with active duty service members and veterans will comply with the provisions set forth 
in DoD Directive 4640.06 (which prohibits discussion of classified information on non-secure calls). 
Information safeguards will comply with DoD Directive 5400.11 (“DoD Privacy Program”). 
This study may involve remote and/or virtual research interactions with participants by the research staff. 
Privacy and confidentiality are not guaranteed due to the nature of the electronic conferencing platforms 
that will be used, but precautions are in place to minimize the risks and participants will be informed of 
actions we and they can take to minimize the risk. 
11.3.1 Measures Taken to Ensure Confidentiality of Data Shared per the Data Sharing Policies 
The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the 
protection of privacy, confidentiality, and security for data dissemination and reuse in accordance with the 
participants’ consent and HIPAA authorization. Plans for archiving and long-term preservation of the data 
will be implemented as appropriate. 
11.4 FUTURE USE OF STORED SPECIMENS AND DATA                                                                N/A ☐ 
A STRONG STAR Repository has been approved by the UTHSCSA (HSC20100475H) IRB to enable the 
STRONG STAR Consortium to store specimens and data for future use. The STRONG STAR Repository 
is a large comprehensive database of information, biological specimens and neuroimages related to the 
identification, assessment, and treatment of insomnia, posttraumatic stress disorder (PTSD), and other 
related behavioral health conditions. All information entered into the STRONG STAR Repository will be 
extracted from primary datasets collected as part of IRB-approved studies, including this study, being 
conducted and /or supported in collaboration with the UTHSCSA STRONG STAR Consortium. Study 
databases are established and maintained by the STRONG STAR Data Core Services. A unique, 
sequential numeric STRONG STAR ID will be assigned to each participant at the time of recruitment into 
this study. However, all Repository data will be identified with a different code number that can be cross 
linked to the original study code only through records maintained by the STRONG STAR Data Core 
Services. At the conclusion of this study, data from participants who signed the consent to have their data 
placed in the STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved 
Repository protocol. For participants who decline participation in the STRONG STAR Repository, their 
data will be de-identified and the data maintained in the Repository without identifiers at the conclusion 
of the study.  
11.5 SAFETY AND CLINICAL MONITORING 
Clinical site safety and data monitoring will be conducted to ensure that the rights and well-being of study 
participants are protected, that the reported study data are accurate, complete, and verifiable, and that the 
conduct of the study is in compliance with the currently approved protocol and applicable regulatory 
requirement(s).  

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The STRONG STAR Data Safety and Monitoring Plan (DSMP) that has been developed in accordance 
with the National Institutes of Health Office of Human Research Protection to assure the appropriate clinical 
safety monitoring of study subjects participating in research will be used to monitor this study. 
Representatives of the Department of Defense (DoD), as well as others, as allowed by federal, and 
university law, regulation, and policy are eligible to review study records. 
11.6 QUALITY ASSURANCE AND QUALITY CONTROL 
Each site will perform internal quality management of study conduct, data and biological specimen 
collection, documentation, and completion. All sites will follow a common quality management plan. 
Quality control (QC) procedures will be implemented as follows: 
• 
Informed consent – Study staff will review both the documentation of the consenting process as 
well as a percentage of the completed consent documents. This review will evaluate accuracy and 
completeness. Feedback will be provided to the study team to ensure proper consenting 
procedures are followed.  
• 
Source documents and the electronic data – Any data initially captured on source documents 
and will ultimately be entered into the study database. To ensure accuracy, site staff will compare 
a representative sample of source data against the database, targeting key data points in that 
review. 
• 
Intervention Fidelity – Consistent delivery of the study interventions will be monitored 
throughout the intervention phase of the study. Procedures for ensuring fidelity of intervention 
delivery are described in Section 7.2.1 (Interventionist Training and Tracking).  
• 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and 
will implement corrective actions when the quantity or nature of deviations are deemed to be at a 
level of concern. 
Should independent monitoring become necessary, the PI will provide direct access to all study-related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
11.7 DATA HANDLING AND RECORD KEEPING 
11.7.1 Data Collection and Management Responsibilities 
Instrumentation.  See Sections 1.2 (Schedule of Events; SOE) and 9 (Study Assessments and 
Procedures) for a summary of the assessments and timing of administration. Assessments will be 
administered in person whenever possible. However, to accommodate participant schedules and/or 
instances in which a participant does not reside in the local area at the time of a follow-up assessment, we 
may collect full or partial assessments in person or via phone, video conferencing, and/or electronic data 
capture using a secure link to the encrypted STRONG STAR database. Reasonable efforts will be made to 
collect all data as described in this protocol, but we expect some participants may not be able to complete 
part or all of any given assessment. 
Data Storage, Access, and Protection. Data will be coded using an assigned number. The key linking 
the participant code number with PII, to include social security number (SSN), will be collected on paper 
and entered into the STRONG STAR password protected database and an Excel spreadsheet housed on a 
secure UTHSCSA server or on the DHA Network in a secure study folder accessible only by members of 
the research team. 
 
In accordance with DoDI 1000.30 (Reduction of Social Security Number (SSN) Use within DoD), the 
participants’ SSNs are being collected and used to: 

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• 
accommodate participants who may not possess alternative ID numbers, such as family members, 
veterans, and civilian research participants and for patient safety by using a feature of the 
STRONG STAR database intentionally built using SSN to ensure the same individual a) 
does not attempt to enroll in the study twice and b) is not enrolled in multiple STRONG STAR 
studies simultaneously without the PIs’ awareness and agreement (Exception category #13 Other 
Cases).  
• 
compensate participants without having income tax withheld (Exemption Category #2.c.7. 
Federal Taxpayer Identification Number) 
 
SSN will be recorded, used, and destroyed as other personally identifying information (PII) and in 
accordance with the participant signed consent and HIPAA authorization. 
Study files containing any hard copies of data collected during study participation will be kept securely at 
STRONG STAR offices in locked cabinets.  
Interview and treatment sessions will occur primarily in person but may occur via phone or using a secure 
HIPAA-compliant video telehealth platform. Data will be stored by an assigned participant code number 
so that data records can be viewed only by password-authenticated, authorized investigators and study 
personnel. Assessment and treatment sessions will be audio-recorded. Recordings will be labeled with the 
participant’s study id number. Through our secured password protected server there is no option for the 
reviewers to download or otherwise save the recordings to their computers. Every member of the 
Research Team will be trained and monitored about how to handle and protect research records. Only 
authorized study staff, and members of the STRONG STAR Data Core staff will have access to either the 
raw data or electronic study data. Section 11.3 (Confidentiality and Privacy) above describes measures 
that will be taken to ensure confidentiality in data storage, access, and protection. 
11.7.2 Study Records Retention 
Informed consent documents will be stored securely for a minimum of three years following completion 
of the research in accordance with 45 CFR 46 or in accordance with institutional requirements, whichever 
is longer. HIPAA authorizations will be stored for a minimum of six years in accordance with HIPAA 
regulations or in accordance with institutional requirements, whichever is longer. After the study has been 
inactivated with the IRB, all other hard copy data will be destroyed in accordance with institutional 
requirements. 
11.8 PROTOCOL DEVIATIONS AND NON-COMPLIANCE 
A protocol deviation is any changed, divergence, or departure from the IRB-approved research protocol.  
• 
Major deviations: Deviations from the IRB approved protocol that have, or may have the 
potential to, negatively impact the rights, welfare or safety of the subject, or to substantially 
negatively impact the scientific integrity or validity of the study. 
• 
Minor deviations: Deviations that do not have the potential to negatively impact the rights, safety 
or welfare of subjects or others, or the scientific integrity or validity of the study. 
The UTHSCSA and STRONG STAR SOPs describing protocol deviations and reports of non-compliance 
will be used to identify and report deviations and/or non-compliance to the IRB.  
11.9 COLLABORATIVE AGREEMENTS                                                                                              N/A ☐ 

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11.9.1 Agreement Type  
A Cooperative Research and Development Agreement (CRADA) Statement of Work (SOW) executed 
under a Master CRADA #MC-22-0179 between UTHSCSA and CRDAMC was fully executed 6 
December 2024 and has been processed in ERMS as CRADA00000023. 
A Defense Health Agency (DHA) Data Sharing Agreement (DSA) will be executed following the 
CRDAMC Human Protections Director’s Administrative Review to access MHS GENESIS to document 
the participant's care delivered per the study protocol and communicate with the participant’s medical 
care team per Section 7.1.3 (Access to and Documentation Care in the Electronic Health Record).  
 
11.10 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this study will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to their participation 
in the design and conduct of this study.   
12. PUBLICATION POLICY 
As a STRONG STAR study, presentations and publications produced as a result of this work will follow 
the STRONG STAR Standard Operating Procedure STRONG STAR-ADM-001-5.0: Review and 
Approval of Publications and Presentation and the International Committee of Medical Journal Editors 
(ICMJE) “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in 
Medical Journals” updated January 2024. 
13. ABBREVIATIONS 
AE 
Adverse Event 
BIS/BAS 
Behavioral Inhibition System/Behavioral Activation System 
CAPS-5 
Clinician Administered PTSD Scale for DSM-5 
CDE 
Common Data Element 
CFR 
Code of Federal Regulations 
CGI 
Clinical Global Impression Scale 
Co-I 
Co-Investigator 
CPT 
Cognitive Processing Therapy 
CRADA 
Cooperative Research and Development Agreement 
CRDAMC 
Carl R. Darnall Army Medical Center 
CRF 
Case Report Form 
CRP 
Crisis Response Planning 
CSSRS 
Columbia Suicide Severity Rating Scale 
DERS-SF 
Difficulties with Emotion Regulation Scale-Short Form 
DHA 
Defense Health Agency 
DoD 
Department of Defense 
DSMB 
Data Safety Monitoring Board 
EMA 
Ecological Momentary Assessment 
GET 
Group Experiential Theme 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
HPD 
Human Protections Director 

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IE 
Independent Evaluator 
INQ 
Interpersonal Needs Questionnaire 
IPA 
Interpretative Phenomenological Analysis 
IRB 
Institutional Review Board 
MCAR 
Missing Completely At Random 
MCQ 
Monetary Choice Questionnaire 
MSRC 
Military Suicide Research Consortium 
OHRO 
Office of Human Research Oversight 
OSU 
The Ohio State University 
PANAS 
Positive and Negative Affect Scale 
PCL-5 
Posttraumatic Stress Disorder Checklist for DSM-5 
PCS 
Permanent Change of Station 
PET 
Personal Experiential Theme 
PI 
Principal Investigator 
PRMRP 
Peer Reviewed Medical Research Program 
PROMIS-CAT 
Patient-Reported Outcomes Measurement Information System Computer 
Adaptive Tests 
PTCI 
Posttraumatic Cognitions Inventory 
PTHI 
Posttreatment Health Interview 
PTSD 
Posttraumatic Stress Disorder 
RCT 
Randomized Clinical Trial 
SAE 
Serious Adverse Event 
SCS-R 
Suicide Cognitions Scale-Revised 
SITBI-R 
Self-Injurious Thoughts and Behaviors Interview-Revised 
SOE 
Schedule of Events 
SOP 
Standard Operating Procedure 
SOW 
Statement of Work 
SSI 
Scale for Suicidal Ideation 
STRONG STAR 
South Texas Research Organizational Network Guiding Studies on Trauma and 
Resilience 
STTS-R 
Satisfaction with Therapy and Therapist Scale-Revised 
TDY 
Temporary Duty 
UPIRSO 
Unanticipated Problem Involving Risk to Subjects or Others 
UTHSCSA 
The University of Texas Health Science Center at San Antonio 
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15. APPENDICES 
1. Case Report Forms; i.e., Questionnaire(s) and Assessments (See Section 9.2 for a Description) 
2. EMA MetricWire “we are concerned about you” Message. 
 
16. PLAN FOR REGULATORY OVERSIGHT 
Institution & Site PI 
Plan for Regulatory Oversight 
University of Vermont (UVM) Principal Investigator: Craig 
Bryan, PsyD, ABPP 
Study Activities: Dr. Bryan will be responsible for overall 
coordination and direction of the research team; will lead the 
development of the study protocols and regulatory reviews; direct 
the hiring, training, and supervision of study staff; direct fidelity 
monitoring; oversee participant recruitment, data collection (to 
include qualitative interviews), data management; direct data 
analyses; and lead the preparation of reports to the funding 
agency and manuscripts reporting the study findings. 
Personnel associated with UVM 
will be engaged in research. We 
will request that UVM defer their 
review to UTHSCSA as both 
organizations are SMART IRB 
members. 
The Ohio State University (OSU), Site Principal Investigator: 
Rosie Bauder, PhD, MPH  
Study Activities: Dr. Bryan will be responsible for overall 
coordination and direction of the OSU research team; will 
oversee data collection (to include qualitative interviews), data 
management; direct data analyses; and lead the preparation of 
reports to the funding agency and manuscripts reporting the study 
findings. 
Personnel associated with OSU 
will be engaged in research. We 
will request that OSU defer their 
review to UTHSCSA as both 
organizations are SMART IRB 
members. 
University of Texas Health Science Center at San Antonio 
(UTHSCSA), Site Principal Investigator and Co-Investigator: 
Alan Peterson, PhD, ABPP 
Study Activities: As Co-I for the proposed project, Dr. Peterson 
will facilitate the use of STRONG STAR resources and assist 
with developing reports, presentations, and manuscripts for the 
dissemination of the study findings.  
Personnel associated with 
UTHSCSA are engaged in 
research. The UTHSCSA IRB has 
agreed to serve as the primary 
IRB. 
Carl R. Darnall Army Medical Center (CRDAMC), Military 
Site PI: MAJ Jennifer Hein, MD 
Study Activities: MAJ Hein will facilitate the conduct of this 
study at CRDAMC, consult for behavioral health issues, facilitate 
Personnel associated with 
CRDAMC will be engaged in 
research. Request that CRDAMC 
defer their review to UTHSCSA 

39 
Abbreviated Title: mCPT+CRP 
Version Date: 07/10/25 
 
HRP503-D Minimal Risk Experimental Protocol Template v2 2.14.2024 
communication with the hospital command, assist with data 
interpretation, and assist with dissemination of the research 
findings. 
under the DHA General Reliance 
Agreement with UTHSCSA.