Decreasing Suicide Risk Among Service Members With Posttraumatic Stress Using Written Exposure Therapy
Phase: NA
Conditions: Suicide, Posttraumatic Stress Disorder
Sponsor: Boston VA Research Institute, Inc.

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1.  PROTOCOL TITLE:  Decreasing Suicide Risk among Service Members with Posttraumatic Stress Using Written 
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Exposure Therapy 
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2.  ABSTRACT   
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Studies of active duty service members have shown that posttraumatic stress disorder (PTSD) is a prevalent 
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condition and that service members who screen positive for PTSD are more than twice as likely to make a suicide 
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attempt (Hoge et al., 2004; Nock et al., 2014). Research has shown that evidence-based PTSD treatments can 
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reduce suicidal ideation (Gradus, Suvak, Wisco, Marx, & Resick, 2013; Bryan et al., 2016); however, it is challenging 
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to provide these treatments to high-risk service members on an acute inpatient unit because they require more time 
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and resources than are typically afforded during inpatients stays. Written Exposure Therapy (WET) is an evidence-
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based, 5-session treatment for managing PTSD (Sloan et al., 2018). WET, adapted for treatment of co-morbid PTSD 
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and suicidality, may overcome many implementation challenges in an inpatient acute care treatment setting (e.g., 
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minimal therapist-patient contact, nominal time needed to train therapists, treatment brevity, and low attrition). 
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Additionally, pilot data indicate that WET reduces suicidal ideation. To directly target suicidal risk and PTSD this 
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study will use a new formulation of WET referred to as WET-for suicide, or WET-S, that includes crisis response 
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planning (CRP) for suicide prevention to the WET condition. WET-S will be delivered in a condensed or “massed’ 
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treatment format, consisting of at least one WET-S session each day.  
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The purpose of this randomized controlled trial (RCT) is to determine if five 60-minute sessions of Written Exposure 
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Therapy for Suicide (WET-S) reduces the presence, frequency, and severity of suicidal ideation, suicide plans, 
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suicide gestures, suicide attempts, non-suicidal self-injurious behaviors, and re-hospitalization for suicidality and if 
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WET-S reduces posttraumatic stress (PTS) symptom severity among 124 service members and veterans admitted to 
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an acute psychiatric inpatient unit for co-morbid suicide ideation (SI) or attempt and PTSD or posttraumatic stress 
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(PTS) compared with Treatment as Usual (TAU). Treatment will be administered during the acute inpatient stay and, 
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if necessary,after discharge into outpatient behavioral health,  to complete the five sessions. Participants will be 
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assessed at pre-treatment, post-treatment, and then 1- and 4-months after treatment completion.  
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3.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS  
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Purpose:  The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of five 60-minute sessions 
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of Written Exposure Therapy for Suicide (WET-S) + Treatment as Usual (TAU) compared with TAU in high-risk, 
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suicidal service members, veterans, and DEERS eligible beneficiaries with posttraumatic stress disorder (PTSD) or 
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posttraumatic stress symptoms (PTSS). 
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Research Aims and Hypotheses:   
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Aim 1: Determine if Written Exposure Therapy for Suicide (WET-S) reduces the presence, frequency, and severity of 
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suicidal ideation, suicide plans, suicide gestures, suicide attempts, non-suicidal self-injurious behaviors, and re-
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hospitalization for suicidality measured by the Self-Injurious Thoughts and Behaviors Interview (SITBI; Nock et al., 
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2007) among service members,veterans, and DEERS eligible beneficiaries  admitted to an acute psychiatric 
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inpatient unit for suicidal ideation (SI) and/or attempt with posttraumatic stress disorder (PTSD) or posttraumatic 
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stress symptoms (PTSS) compared with Treatment as Usual (TAU). 
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Hypothesis 1. Compared with TAU alone, WET-S + TAU will result in significantly greater reductions in 
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suicide-related outcomes pre-treatment to 1- and 4-months follow-up. 
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Aim 2: Determine if Written Exposure Therapy for Suicide (WET-S) reduces posttraumatic stress symptoms (PTSS) 
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severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Weathers, Blake, Schnurr, 
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Kaloupek, Marx & Keane, 2013) among service members, veterans, and DEERS eligible beneficiaries  admitted 
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to an acute psychiatric inpatient unit for suicidal ideation (SI) or attempt and posttraumatic stress disorder (PTSD) or 
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PTSS compared with Treatment as Usual (TAU.)  
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HUMAN SUBJECTS RESEARCH PROTOCOL  

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Hypothesis 2. Compared with TAU alone, WET-S + TAU will result in significantly greater reductions in 
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PTSS severity from pre- to post-treatment, 1- month, and 4-month follow-up. 
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Aim 3: Determine if reductions in posttraumatic stress symptoms (PTSS) severity mediate the association between 
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treatment condition and suicide-related outcomes (suicidal ideation, plans, gestures, attempts, non-suicidal self-
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injurious behaviors, and re-hospitalizations) measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-
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5) and the Self-Injurious Thoughts and Behaviors Interview (SITBI).  
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Hypothesis 3. WET-S + TAU will demonstrate an indirect effect on suicide-related outcomes through greater 
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reductions in PTS symptoms as compared with TAU.  
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4.  MILITARY RELEVANCE  
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Currently, service members and veterans have unacceptably high rates of suicidal behavior and PTSD. The 
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military’s immediate and long-term mission readiness would benefit from a brief, easily implemented, evidence-
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based intervention that meaningfully reduces the future risk of suicide among service members with PTSD and 
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improves morale. Active duty work and schedule demands require efficient treatment delivery models (e.g., 
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treatment delivered in a condensed format of consecutive daily sessions) and psychiatric inpatient treatment 
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focused on suicide risk stabilization is typically a short time period. Because WET-S is brief, easy to administer, and 
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requires fewer resources and training to administer, it could very easily be scaled up and disseminated. This 
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advantage would allow service members to engage in this therapeutic technique in a variety of settings (e.g., home, 
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barracks, in theatre) with a high degree of privacy and a significantly reduced effort by already overburdened 
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military mental health providers. This privacy and flexibility may help reduce stigma concerns. This project targets 
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active duty military personnel at varying stages of psychiatric care: the inpatient stay, the high-risk post-discharge 
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period, and the return to living within their military communities. WET-S can be disseminated easily across DoD to 
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reduce suicidal behavior among service members and veterans. Overall, although we expect that WET-S will prove 
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useful to the general population, we believe this time-efficient, cost-effective, and easily implemented intervention 
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holds special promise for improving the prevention of suicidal behavior among service members and veterans. 
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5. BACKGROUND AND SIGNIFICANCE   
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Studies of active duty service members have shown that PTSD is a prevalent condition and that service members 
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who screen positive for the disorder are more than twice as likely to make a suicide attempt (Hoge et al., 2004; Nock 
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et al., 2014). Research has shown that evidence-based PTSD treatments can reduce suicidal ideation (Gradus, 
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Suvak, Wisco, Marx, & Resick, 2013; Bryan et al., 2016); however, it is challenging to provide most of these 
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treatments to high-risk service members on an acute inpatient unit because they require more time and resources 
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than are typically afforded during inpatients stays. This means that those with PTSD who are at highest suicide risk 
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are not receiving treatment for PTSD until they are discharged from the hospital and there is no available evidence to 
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suggest that treatment as usual in inpatient psychiatric settings reduces the likelihood of suicide after discharge. 
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WET is a 5-session treatment that is included in the 2017 VA/DoD Clinical Practice Guidelines for managing PTSD 
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(2017). WET is associated with large within- and between-group effect sizes that are comparable with other 
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evidence-based PTSD treatments (Sloan, Marx, et al., 2018). Sloan and colleagues (2012) examined the efficacy of 
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WET relative to wait list (WL) comparison condition delivered to men and women who had a diagnosis of PTSD 
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related to a motor vehicle accident. Intent to treat findings indicated a very large between group differences (Cohen’s 
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d = 2.49 and 2.19 at post-treatment and 3-month follow-up, respectively), with 91% of participants no longer meeting 
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diagnostic criteria for PTSD 6 months following treatment (Sloan et al., 2012). Moreover, WET was associated with 
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low attrition (n = 2; 9%) and high treatment satisfaction ratings. Next, WET was compared with Cognitive Processing 
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Therapy for PTSD, a first- line PTSD treatment that is much more time intensive than WET, in a non-inferiority trial. 
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Participants in both treatments displayed a significant reduction in PTSD symptom severity (large within group effect 
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sizes).  However, a significant treatment condition difference in dropout was also observed, with 39% dropout in CPT 
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compared with 6% in WET (Sloan et al. (2018). Thus, WET may overcome many implementation challenges in an 
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inpatient acute care treatment setting (e.g., minimal therapist-patient contact, nominal time needed to train therapists, 
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treatment brevity, and low attrition). Preliminary data suggest that WET also reduces suicidal ideation. Specifically, 
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secondary analysis of data from the WET vs. CPT study sample demonstrated that among those who received WET 
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and who endorsed SI at baseline (n = 18 of 63; 28.57%), a significant effect of linear time was observed (B = 0.338, 
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SE = 0.07, p<.001), indicating that participants were significantly less likely to endorse SI over time. Roughly half of 
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those who endorsed SI at baseline no longer endorsed SI 60 weeks later. 
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To directly target suicidal risk and PTSD among service members admitted to an acute psychiatric inpatient unit the 
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study will use a new formulation of WET referred to as WET-for suicide or WET-S that includes crisis response 
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planning (CRP) for suicide prevention to the WET condition. CRP is a brief strategy that reduces suicide attempts 
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among military personnel by 76% compared with typical suicide risk management strategies (Bryan et al., 2017a). 
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CRP also contributes to significantly faster reductions in suicide ideation (Bryan et al., 2017a), as well as immediate 
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reductions in emotional distress and suicidal intent (Bryan et al., 2017b). WET-S aims to work synergistically by 
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addressing trauma-related symptoms or cognitive-affective states (e.g., intrusive thoughts, self-blame, hyperarousal) 
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that are both PTSD treatment targets and warning signs for suicidal thoughts and behaviors (Bryan, 2016; Bryan, 
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Grove, & Kimbrel, 2017). The development and review of CRP aims to support the regulation of these trauma-
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focused cognitive-affective states (among other patient warning signs) while the patient engages in trauma-focused 
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treatment through the WET protocol.  
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WET-S will be delivered in a condensed or “massed’ treatment format, consisting of at least one WET-S session 
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each day. For some patients, two WET-S sessions per day may be considered with the objective that the protocol 
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is completed prior to discharge. Recent data support condensed formats version of evidenced-based cognitive 
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behavioral therapies for PTSD work equally well as the spaced (weekly) version with significantly less dropout (Foa 
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et al., 2018; Fredman et al., 2018; Peterson et al., 2018). Although primary data exist to support reductions in suicide 
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risk with WET, it has yet to be tested with patients at high risk for suicide requiring inpatient hospitalization 
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management. Therefore, as a part of risk management strategies for the experimental treatment of WET with this 
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population we are including increased suicide risk monitoring and management by the inclusion of CRP in the WET 
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condition (WET-S). WET-S will be delivered in five sessions, with the allowance of an additional two WET-S 
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sessions, based on therapist judgment to support good end state functioning and treatment goals to reduce PTS 
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symptoms. 
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Telehealth is an essential and safe mode of delivering mental health services, to include the delivery of exposure-
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based PTSD treatment17, 18. Telehealth is broadly defined as behavioral health services that are delivered via 
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communication technologies including telephone and clinical video teleconferencing. Because of the physical 
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distancing recommendations in place with the COVID-19 pandemic, all assessment and treatment sessions for this 
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study will occur using a computer or tablet talking over a secure line in real-time with the research staff using a 
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computer in his or her office. The video telehealth platform used for these communications is HIPAA-compliant. 
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While participants are in care at the CRDAMC inpatient unit, the computer or tablet will be provided by the staff to 
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use for study procedures only. For sessions or assessment that occur after participants are discharged from inpatient 
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care, participants will need to use a computer with high speed internet access (e.g., broad-band internet connection 
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of at least 384kbps at 720 pixels) to support the telehealth platform. The computer must be equipped with speakers 
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or a standard headphone jack to be able to hear and speak with the research staff. Participants will also need to 
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have access to a private location with the ability to control access during assessment and treatment sessions to 
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ensure your privacy and confidentiality.  If participant does not have access to a computer in a private location, they 
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can come to the STRONG STAR offices located at the Shoemaker Center on Fort Hood and use a computer in one 
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of our offices 
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6.  RESEARCH DESIGN   
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The proposed randomized controlled trial will examine the efficacy of the WET-S + TAU compared with TAU alone 
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among high-risk, suicidal service members and veterans with PTSD or PTSS admitted to the CRDAMC acute 
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inpatient psychiatry unit for suicide risk. Assessment and treatment session will be delivered via a HIPAA compliant 
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video telehealth platform. The design overview of the study is summarized in Figure 1.  
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Figure1. Study Design Overview. 
Initial Screening Evaluation 
Informed Consent, Baseline Assessment, and Randomization  
Interviews and self-report measures 
WET-S + TAU 
5 consecutive daily sessions of WET-S + TAU 
TAU 
Daily standard treatment delivered  

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7.  RESEARCH PLAN 
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7.1 Selection of Subjects 
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Target enrollment (number consented): 140 
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Target number randomized: 124 
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7.1.1. Subject Population. Active duty military service members and veterans admitted to the CRDAMC inpatient 
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psychiatry unit for treatment for suicidal thoughts or behaviors and PTS. The study will use a continuous enrollment 
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process to allow for maximum flexibility in meeting individual patient/participant scheduling needs.  Active duty service 
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members will have priority for being enrolled in the study. 
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7.1.2. Source of Research Material. Interviews, self-report questionnaires, medical record review.  
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7.1.3. Inclusion and Exclusion Criteria.  
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Inclusion Criteria 
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1. Active duty military service member, veteran, or and DEERS eligible beneficiary (age 18- 65 years) 
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hospitalized at Carl R Darnall Army Medical Center (CRDAMC) for non-suicidal self-injury, suicide 
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thoughts, suicide plan or attempt confirmed by CRDAMC inpatient admission documentation.    
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2. PTSS of at least moderate severity (total scores > 20) confirmed by the CAPS-5. 
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3. Speak, read, and write English. 
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Exclusion Criteria 
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1. Active psychosis. 
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2. The presence of moderate to severe cognitive impairment (as determined by the inability to comprehend the 
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baseline screening questionnaires).  
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3. The presence of any clinically significant factor that may impair an individual’s ability to comprehend and 
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effectively participate in the study, e. g., the presence of extreme agitation or violent behavior. 
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7.1.4. Description of the Recruitment and Prescreening Process.  Under a waiver HIPAA Authorization for screening, 
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study staff will collaborate with CRDAMC staff to identify potential participants who have been admitted for suicide 
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thoughts and/or suicidal behaviors and that have symptoms of PTS as documented as part of the admission 
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assessments.  
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7.1.5. Pre-Screening and Consent Process. A CRDAMC staff member will identify potential participants 
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as part of their admission assessment of new patients. UTHSCSA STRONG STAR staff will attend the unit morning 
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meeting via telephone. Following the morning meeting, a CRDAMC inpatient staff member will introduce the 
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UTHSCSA STRONG STAR staff to the patient via a HIPAA compliant video telehealth platform. Potential participants 
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will be approached to consider participation in this study as soon as is practically and clinically feasible after their 
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initial evaluation and stabilization.  An authorized and trained member of the research team will engage the potential 
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participant in an interactive explanation of the study guided by the informed consent document (ICD). During the 
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consent appointment, potential participants will have the study explained to them in a private location on the inpatient 
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1-Month Follow-Up Assessment 
Interviews and self-report measures 
4-Month Follow-Up Assessment  
Interviews and self-report measures 
Posttreatment 
Administration of self-report measures  

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psychiatry unit. The potential participant will be given a copy of the informed consent document (ICD) to read. After 
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the potential participant has read the ICD, they will be given the opportunity to discuss the research with family and 
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friends. Once the potential participant has reached a decision, a member of the study team will again review with the 
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participant the purpose of study, duration of study, study procedures, the experimental components of the study, the 
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potential risks and discomforts, the potential benefits, any alternatives to participation, protection of participant’s 
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confidentiality, and the contact information for both the researchers and the regulatory bodies overseeing the 
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conduct of the study to ensure the participant has an understanding of the study. If the individual is agreeable to 
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participation, the informed consent document will be signed electronically or on paper form by the participant. A 
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clean copy of the informed consent form will be given to the patient.  During the course of the study, the research 
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team will be available to answer any questions about the research, and ongoing discussions will occur to ensure the 
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participant’s questions and concerns are addressed. Baseline assessment for screening will occur after consent.  
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7.1.6. Subject Screening Procedures. Once the informed consent is completed, participants will complete the 
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baseline questionnaires and study interviews with the Independent Evaluator (IE) to ensure inclusion and exclusion 
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criteria are met. The first choice will be for the participant to complete all measures online through a secured 
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electronic link. Interview assessments will be conducted using a HIPAA-compliant video telehealth platform.  In the 
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event there are technical difficulties, consent and self-report assessment measures may be completed on paper.  
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7.1.7. Compensation for participation.  Participants will not be compensated for participation.  
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7.1.8. Treatment Procedures.   
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Written Exposure Therapy-for Suicide (WET-S). Typically, WET-S consists of 5 treatment sessions, each lasting 
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approximately 60 minutes, with the exception of the first session which will last 90 minutes. Each session includes a 
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written exposure exercise for participants randomized to the WET+TAU arm. The first session will consist of the 
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therapist educating the participant about common reactions to trauma and providing information regarding the 
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rationale of WET-S as a treatment for PTSD. The participant will then be given general instructions for completing 
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the trauma narratives, specific instructions for completing the first session, and will then complete the first narrative 
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writing session. Participants will be instructed to write about the same trauma experience during each session. This 
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event will be the same event identified as the index trauma during the baseline assessment session. The importance 
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of delving into their deepest emotions surrounding the trauma event is emphasized, as well as the importance of 
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providing detailed information about the event. All WET-S sessions will take place via a HIPAA-compliant video 
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telehealth platform in a private room on the inpatient ward while being monitored by inpatient staff. The participant 
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will be provided with the writing instructions and the provider will remain virtually connected with the patient while the 
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writing session is completed.  Writing instructions begin with a focus on describing the details of the trauma and 
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emotions and thoughts that occurred during the traumatic event and then change to a focus on the meaning of the 
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trauma event (e.g., what the event has meant to the person, how it has changed the way they view his or her life). 
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Based on regular consultation between the treating therapist and supervising investigators, 1 to 2 additional WET-S 
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sessions will be provided to ensure the rationale of WET-S as a treatment for PTSD is understood by the participant 
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and to allow for a full course of WET-S sessions. WET-S will be delivered in a condensed or “massed’ treatment 
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format, consisting of at least one WET-S session each day until the treatment is complete. For some participants, 
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two WET-S sessions per day may be considered to complete the protocol prior to discharge if possible. However, if 
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participants are discharged from inpatient care prior to completing the WET-S protocol, WET-S will continue using a 
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secure HIPAA-compliant video telehealth platform. 
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WET-S treatment also includes the development and monitoring of a Crisis Response Plan (CRP) for suicide risk. 
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Participants assigned to WET-S will complete the CRP prior to beginning their writing in session 1. Patient use of the 
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CRP since the previous session will be briefly reviewed at the start of each WET-S session to manage safety and 
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problem solve fluctuations in risk during treatment.  
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Treatment As Usual (TAU). The TAU condition consists of daily contact and patient centered care by the acute 
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psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers, behavioral health techs). TAU 
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includes initial psychiatric stabilization, nurse case management, medication management, psychoeducation groups, 
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and discharge planning. Patients engage with the provider team daily and have structured times for psychoeducation 
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groups, case management, medication management, hygiene, and meals. 
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7.2 Drugs, Dietary Supplements, Biologics, or Devices.  N/A 
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7.3. Study Procedures/Research Interventions.   
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Study Procedures 
Baseline 
Post-BL 
(w/in 48 
hrs of 
baseline) 
 Post-
Treatment 
session 
1-Mo 
FU+/- 1 
week 
4-Mo FU 
+/- 3 
weeks 
Informed Consent 
X 
 
 
 
 
Randomization 
 
X 
 
 
 
1. Supplemental Demographics Form 
X 
 
 
 
 
2. Military Suicide Research Consortium (MSRC) 
Demographics  
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3. MSRC Common Data Elements 
X 
 
 
X 
X 
4. Health Questionnaire 
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X 
X 
5. Self-Injurious Thoughts and Behaviors Interview (SITBI) 
X 
 
 
X 
X 
6. Depression Symptom Index-Suicidality Subscale (DSI-SS) 
X 
 
X 
X 
X 
7. Clinician Administered PTSD Scale (CAPS-5) 
X 
 
 
X 
X 
8. Life Events Checklist for DSM-5 (LEC-5) 
X 
 
 
 
 
9. PTSD CheckList-5 (PCL-5) 
X 
 
X 
X 
X 
10. Risk and Resilience Inventory (DRRI-2) Subscales:  
- Combat Experience  
- Post-battle Experiences 
X 
 
 
 
 
11. Monetary Choice Questionnaire 
X 
 
X 
X 
X 
12. Suicide Cognitions Scale – Short Form (SCS-S) 
X 
 
X 
X 
X 
13. Posttraumatic Cognitions Inventory (PTCI) 
X 
 
X 
X 
X 
 
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7.3.1 Collection of Human Biological Specimens.  N/A 
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7.3.2 Data Collection.   
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7.3.2.1 Instrumentation. See the table in Section 7.3 for a summary of the assessments and timing of 
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administration.  A description of each of the assessments can be found at the end of this protocol.  Assessments will 
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be administered via a secure HIPAA-compliant video telehealth platform, phone, in person, or electronic data capture 
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using a secure link to the encrypted STRONG STAR database. Reasonable efforts will be made to collect all data as 
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described in this protocol, but we expect some participants may not be able to complete part or all of any given follow 
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up assessment. 
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7.3.2.2 Data Storage, Access and Protection 
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Interviews and treatment sessions will occur using a secure HIPAA-compliant video telehealth platform. Data will be 
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stored by an assigned participant code number so the data records can be viewed only by password-authenticated, 
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authorized investigators and study personnel. Recordings will be labeled with participant's study ID number. Through 
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our secured password protected server there is no option for the reviewers to download or otherwise save the 
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recordings to their computers. Every member of the Research Team will be trained and monitored about how to 
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handle and protect research records. Only authorized study staff, and members of the STRONG STAR Biostatistics 
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and Data Management Core staff will have access to either the raw data or electronic study data. Any hard copies of 
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data collected during treatment will be placed into a lock box which will be transported by car to the UTHSCSA 
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STRONG STAR offices by a STRONG STAR staff member who will place it into the locked cabinets at the STRONG 
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STAR offices. 
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Data will be entered into the STRONG STAR password protected database housed on a secure UTHSCSA server 
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(physically located at the Centralized Computing Facility) by member of the research team. Electronic data will be 
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stored, managed, and analyzed by the STRONG STAR – CAP Data and Statistics Core staff of the STRONG STAR 
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consortium. The overall PI and named collaborators will have access to identifiable data through the STRONG STAR 
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website and UTHSCSA server. 
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All UTHSCSA STRONG STAR network connectivity is segmented with Access Control Lists and is not accessible to 
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any other UTHSCSA network segments. STRONG STAR data server is physically located at the Advanced Data 
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Center (ADC)  has 24x7 onsite security, card key, biometric access controls and video surveillance. University of 
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Texas Health Science Center at San Antonio (UTHSCSA) ADC facility also maintains Gen 2 firewall devices to 
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protect and prohibit any unauthorized access to UTHSCSA data. All UTHSCSA network devices are monitored by 
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state-of-the-art monitoring applications that include configuration audit, management, and availability 24x7. 
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The UTHSCSA STRONG STAR data server is currently a VMware Instance running Windows Server 2016 
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Enterprise Standard with daily backup services and vSphere Business Continuity Advanced Failover. 
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Only select Data Core personnel have direct access to the data on a “need to access basis”. Data Core also follows 
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the Principals Of Least Privilege (POLP).  For example (but not limited to) detecting and repairing data corruption 
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and producing reports not currently within the STRONG STAR system. All user activity is tracked and recorded within 
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the system so if any records are added, altered or viewed the action is recorded and can be recalled for auditing 
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purposes. Access to this information will require a password-protected login available only to authorized Core staff. 
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This is a single-site study; all study procedures with human subjects will be conducted at the Carl R. Darnall Army 
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Medical Center (CRDAMC) on Ft Hood in Texas by UTHSCSA employees in collaboration with the active duty or GS 
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On-Site collaborator.  
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Every member of the Research Team will be trained and monitored about how to handle and protect both medical 
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and research record in the context of video telehealth appointments.  Furthermore, the Research Team strictly 
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controls access to study data. 
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Additionally, as a requirement of the funding of this study by the Military Suicide Research Consortium (MSRC), the 
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research team is required to administer the MSRC Common Demographics (CDem) and Data Elements (CDE) and 
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upload a limited data set (with dates but without other identifiers) as a SPSS file to the MSRC website housed at 
346 
Florida State University (FSU) under protocol number FSU HSC#2018.23936. Participants are notified of this as part 
347 
of the consent and HIPAA authorization. 
348 
 
349 
The STRONG STAR Data Safety and Monitoring Plan (DSMP) that has been developed in accordance with the 
350 
National Institutes of Health Office of Human Research Protection to assure the appropriate clinical safety monitoring 
351 
of study subjects participating in research will be used to monitor this study. 
352 
 
353 
7.3.3. Human Biological Specimen (Biomarker) Processing. N/A 
354 
 
355 
7.4 Statistical Consideration  
356 
 
357 
7.4.1 Sample Size Estimation.  Based on our prior work, we expected WET-S to have a very large effect on both PTSD 
358 
symptoms and suicide-related outcomes over and above TAU. However, to be conservative given tempered 
359 
expectations in this yet unstudied population, we powered the study to detect small to medium sized effects for the group 
360 
by time interaction. Power was estimated using Repeated Measures and Sample Size computer software, accessible at 
361 
https://rmass.org. Assuming subject level randomization, a quadratic design matrix for the time effect, a 1-tailed alpha 
362 
level of .05, desired power of .80, equal sized treatment groups at baseline, an overall expected 15% attrition rate, a 
363 
stationary AR1 error correlation matrix starting at a modest r = .30, and desire to be able to detect at least a conventional 
364 
small to medium sized effect (d = .35) at the final assessment, the desired total sample size we intend to recruit is N = 
365 
124 (n = 62/group), a feasible recruitment goal given the targeted population. 
366 
 
367 
7.4.2 Primary (i.e., primary outcome variables) and secondary endpoints. The primary dependent variables for suicidality 
368 
are the Self-Injurious Thoughts and Behaviors Interview (SITBI) interview and the Depression Symptom Index-Suicidality 
369 
Subscale (DSI-SS) self-report.  The primary dependent variables for PTS symptoms and PTSD are the Clinician 
370 
Administered PTSD Scale (CAPS-5) interview and the PTSD CheckList-5 (PCL-5) self-report.  Secondary endpoints 
371 
include associated psychopathology (severity scores on measures of depression, general anxiety, anger, and PTSD-
372 
related cognitions) 
373 
 
374 
7.4.3 Data Analyses. To examine hypothesis 1 (determine if WET-S + TAU reduces presence (past month), frequency, 
375 
and severity of suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self-injurious 
376 
behaviors and re-hospitalizations related to suicidality relative to TAU only and hypothesis 2 (determine if WET-S + TAU 
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reduces PTS symptom severity relative to TAU only) , we will conduct intent-to-treatment (ITT) analyses including all 
378 
randomized participants who attend at least the first therapy session. General or Generalized Linear Mixed Effects 
379 
models, depending on the nature of the specific outcome, will be implemented for the primary ITT randomized 
380 
comparison of total CAPS-5 scores as well as SITBI variables of interest and number of subsequent inpatient 
381 
hospitalizations for suicidal behavior. The planned statistical design includes fixed effects for treatment (between-
382 
groups), time (within-subjects), and the group by time interaction. This latter effect captures differences in changes over 
383 
time between the groups; as such it is the effect of substantive interest in each of the models that will be examined. 
384 
Advantages of the general(ized) linear mixed effects model include the ability to include cases with missing data 
385 
(assumed missing at random), flexible specification of the covariance structure among the repeated measures, the ability 
386 
to model nonlinear trajectories of change over time, and the ability to perform between- and within-groups contrasts both 
387 
at and across assessments to examine significant group by time interactions. Prior to performing statistical analyses, the 
388 
data will be inspected to determine the advisability of scale transformation to normalize distributions (where applicable) 
389 
or reduce variance heterogeneity and to identify missing data, outliers, or other unusual features that may be influential. 
390 
To test hypothesis 3, growth curve modeling will be used to examine mediation. Specifically, treatment condition will be 
391 
entered as a predictor of change in both PTS symptom severity and suicide related outcomes. To achieve mediation, 
392 
WET-S +TAU would achieve superior reductions in suicide related outcomes and PTS symptom severity relative to TAU 
393 
only. Finally, we will examine the indirect effect of treatment condition on suicide related outcome change via PTSD 
394 
symptom change. Identification of an indirect effect would allow us to conclude that WET-S + TAU’s superior effect on 
395 
suicide risk relative to TAU only is mediated by changes in PTS symptoms. 
396 
 
397 
7.7 Confidentiality.  All video telehealth therapy sessions and interview assessments will be conducted in private offices 
398 
in the CRDAMC acute inpatient psychiatry unit and then via video telehealth from a private location of the participant's 
399 
choosing once the participant is discharged from inpatient care. All assessment interviews and WET-S treatment 
400 
sessions speaking with the therapist will be recorded using an audio-recorder external to the HIPAA compliant telehealth 
401 
platform. Recordings will be labeled with the participant’s study ID number.  
402 
The recordings will be uploaded to a secure password protected server immediately after the session is completed. The 
403 
recording will then be deleted from the recorder. Study staff will be responsible to upload the audio-recording as soon as 
404 
possible and then deleting the recording from the audio-recorder.  
405 
 
406 
7.7.1 Certificate of Confidentiality.  We are not seeking a Certificate of Confidentiality. 
407 
 
408 
7.7.2 Long Term Data Storage.  A STRONG STAR Repository has been approved by the UTHSCSA 
409 
(HSC20100475H) IRB to enable the STRONG STAR Consortium to store specimens and data for future use. The 
410 
STRONG STAR Repository is a large comprehensive database of information, biological specimens and 
411 
neuroimages related to the identification, assessment, and treatment of posttraumatic stress disorder (PTSD), 
412 
insomnia, pain, and related behavioral health conditions.  All information entered into the STRONG STAR Repository 
413 
will be extracted from primary datasets collected as part of IRB-approved studies, including this study, being 
414 
conducted and /or supported in collaboration with the UTHSCSA STRONG STAR Consortium.  Study databases are 
415 
established and maintained by the Data Management and Biostatistics Core of the STRONG STAR Consortium.  A 
416 
unique, sequential alpha-numeric STRONG STAR ID will be assigned to each participant at the time of recruitment 
417 
into this study. However, all Repository data will be identified with a different code number that can be cross linked to 
418 
the original study code only through records maintained by the STRONG STAR Data Management and Biostatistics 
419 
Core. At the conclusion of this study, participants who signed the consent to have their data placed in the STRONG 
420 
STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol.  For participants who 
421 
decline participation in the STRONG STAR Repository, at the conclusion of the study their data will be de-identified 
422 
and the data maintained in the Repository without identifiers. 
423 
 
424 
 
425 
8.0 RISKS/BENEFITS ASSESSMENT 
426 
 
427 
8.1 Risks.   
428 
 
429 
Likely but not Serious (expected to occur in more than 1 in 5 participants): 
430 
• 
Participating in mental health treatment and research might increase some symptoms and increase the risk 
431 
of feeling emotionally uncomfortable in the short term, which might increase the desire for suicide 
432 
temporarily. This increase is usually not severe, however, and does not last long. Preliminary work with 
433 
these interventions suggest participants typically experience decreased emotional distress immediately 
434 
afterwards. 
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• 
Possibility of becoming emotionally upset or experiencing an initial increase of PTSD symptoms due to the 
436 
discussion or journaling of traumatic events.  
437 
 
438 
Rare and Serious (expected to occur in less than 5 out of 100 participants): 
439 
• 
With the handling of medical and research records there is always the possibility of a breach of 
440 
confidentiality. However, every effort is made to protect the privacy of participants. Every member of the 
441 
research team is carefully trained and monitored about how to store, handle, and protect participant records. 
442 
• 
Assessment and therapy sessions that are conducted via video telehealth are subject to risks to 
443 
confidentiality if others in the CRDAMC inpatient ward or home or other location can hear what is being said 
444 
during the encounter. To minimize this risk, while in the inpatient ward participants will be placed in a private 
445 
room while monitored by a CRDAMC staff member when doing study activities. When the patient is 
446 
completing a video telehealth therapy session or assessment following discharge from the inpatient ward, 
447 
participants will be encouraged to use headphones and to find a quiet area of the home to hold the 
448 
encounter. Also, although video telehealth sessions are transmitted securely, there is always a risk that 
449 
others (not affiliated with this research) could breach the network security systems and access the 
450 
information. Ensuring that the participant has a virus protection on his or her computer will minimize this risk. 
451 
• 
It is possible that technical difficulties will result in missing a scheduled treatment session. The research 
452 
team will work closely with participants to solve technical problems to minimize missed treatment time and 
453 
also to re-schedule and conduct missed treatment sessions as soon as possible. 
454 
 
455 
Risks of Suicidality Thoughts and Behaviors or a PTSD Diagnosis regardless of Treatment.  One of the risks 
456 
of suicidality thoughts and behaviors as well as PTSD both in and out of treatment is attempted suicide, which can 
457 
result in death.  Prior research has shown that, following a suicide attempt, up to half of patients in treatment make 
458 
another suicide attempt. If the suicide attempt occurs within the first year of treatment, on average a patient will 
459 
attempt suicide 2.5 times.  However, safeguards for protecting participants are planned as described below. 
460 
 
461 
Safeguards for Protecting Participants.  
462 
 
463 
Because encounters will be conducted through video telehealth while the participant is on the inpatient ward, a 
464 
CRDAMC staff member will monitor the visit while also allowing for privacy. Following discharge, when engaged in 
465 
video telehealth sessions, participants will be asked to provide the name, phone number and address of a participant 
466 
support person who is at least 18 years of age, able to be contacted by phone and can arrive to the participant's 
467 
location within 30 minutes in an emergency. 
468 
 
469 
Any indication that the participant is considering suicide will be handled following care facility SOPs and using 
470 
processes developed by military and civilian consultants to the STRONG STAR Consortium. Trained clinicians and 
471 
evaluators will assess history of suicide and current suicidal ideation using standardized measures. Treatment that 
472 
takes place while the participant is on the inpatient unit includes standard procedures within the unit for managing 
473 
suicide risk and is a treatment milieu focused on managing acute suicide risk. Any treatment sessions or 
474 
assessments completed in outpatient care via video telehealth will follow standard suicide risk management 
475 
procedures. CRDAMC acute inpatient psychiatric unit has a standard operating procedure for managing suicide risk 
476 
after discharge that includes scheduled a written safety plan for patients and behavioral health appointments for 
477 
follow-up care and medication management within CRDAMC outpatient Department of Behavioral Health.    
478 
When participants are seen by study staff, severe suicidal ideation could also be addressed through the 
479 
development of a Crisis Response Plan and/or referral to local resources for additional information.  Priority will be 
480 
given to referring patients to the CRDAMC outpatient Department of Behavioral Health. 
481 
 
482 
Our study will mitigate risk for possible increased emotional distress by obtaining ratings of mood and suicidal intent 
483 
on a recurrent basis from all study participants and taking action as clinically indicated. Preliminary data further 
484 
suggest that the procedures used in this study are associated with immediate decreases in emotional distress and/or 
485 
increases in positive emotions among high-risk military personnel. 
486 
 
487 
To mitigate risk associated with loss of confidentiality, we have ensured that all procedures and data storage 
488 
methods are secure. Access to data is restricted to research staff on an as-needed basis, research staff are trained 
489 
regularly in confidentiality and privacy issues, research staff participate in weekly supervision, and quality assurance 
490 
checks are conducted annually.  
491 
 
492 

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Research Monitor.  
493 
Vanessa Green, D.O. will serve as the DoD Independent Research Monitor.  The duties of the research monitor shall 
494 
be determined on the basis of specific risks or concerns about the research. The research monitor may perform 
495 
oversight functions (e.g., observe recruitment, enrollment procedures, and the consent process for individuals, 
496 
groups or units; oversee study interventions and interactions; review monitoring plans and UPIRTSO reports; and 
497 
oversee data matching, data collection, and analysis) and report their observations and findings to the IRB or a 
498 
designated official.  The research monitor may discuss the research protocol with the investigators, interview human 
499 
subjects, and consult with others outside of the study about the research. The research monitor shall have authority 
500 
to stop a research protocol in progress, remove individual human subjects from a research protocol, and take 
501 
whatever steps are necessary to protect the safety and well-being of human subjects until the IRB can assess the 
502 
monitor’s report. Research monitors shall have the responsibility to promptly report their observations and findings to 
503 
the IRB or other designated official. 
504 
 
505 
8.2 Potential Benefits.  Potential benefits of participation in this study may include a reduction in self-injurious thoughts 
506 
and behaviors and PTSD symptoms over the course of therapy. Our primary goals are to treat participants to reduce long 
507 
term suicide risk and to the point of symptoms reduction below the level of diagnostic criteria for PTSD. In addition, the 
508 
knowledge gained from this study will serve to inform the most effective early interventions for the prevention and 
509 
treatment of suicide risk and PTSD. 
510 
 
511 
8.3 Alternatives. Mental health treatment for both suicidality and PTSD is available via video telehealth at CRDAMC 
512 
through the Department of Behavioral Health (DBH) including various forms of psychotherapy and drug treatments.  
513 
Service members and veterans can access treatment for suicide risk and PTSD from the DBH as well as through Army 
514 
One-Source and may be eligible for care at one of the Veterans Healthcare System facilities or clinics.  Not participating 
515 
in the study is also an alternative. 
516 
 
517 
9.0  ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
518 
 
519 
9.1   Adverse Events will be assessed and monitored according to the established STRONG STAR SOP and the IRB of 
520 
record’s policies and procedures. 
521 
 
522 
9.2 Reporting Adverse Events, Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs), and 
523 
Deviations to the Office of the IRB.  All adverse events, unanticipated problems involving risk to subjects or others, 
524 
and deviations will be reported to the Institutional Review Board (IRB) in accordance with current IRB policy.  UPIRSOs 
525 
and recurrent non-compliance with study procedures will be reported promptly to the IRB.  All adverse events that do not 
526 
meet the UPIRSO criteria and deviations that are not non-compliance will be summarized at Continuing Review per the 
527 
IRB of record’s policy.   
528 
 
529 
10.0 WITHDRAWAL FROM STUDY PARTICIPATION  
530 
 
531 
Participants may withdraw themselves from this study at any time and for any reason. Withdrawal from this study 
532 
does not affect the participant’s eligibility for care or any other benefits to which entitled.  Participants who request to 
533 
discontinue treatment, but who do not choose to withdraw from the study completely, will be asked to return for the 
534 
post-treatment assessments. If a participant stops attending treatment sessions without notifying research staff, the 
535 
therapist or project coordinator will make diligent attempts to contact the person to evaluate their status, attempt to 
536 
re-engage them in the treatment, and encourage them to complete follow up assessments.  Research staff will also 
537 
refer to appropriate outside resources if necessary.  Investigator may choose to withdraw a participant after 
538 
consultation with the treating therapist and other consultants as appropriate in instances not limited to: 
539 
• 
Patient is noncompliant with treatment requirements 
540 
• 
Patient is in need of more intensive treatment 
541 
• 
Patient’s symptoms worsen significantly 
542 
• 
Patient experiences a serious adverse event that is clearly related to the treatment 
543 
• 
Unexpected unavailability of a treating therapist   
544 
 
545 
11.0 REFERENCES 
546 
 
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1. Hoge, C. W., Castro, C. A., Messer, S. C., McGurk, D., Cotting, D. I., & Koffman, R. L. (2004). Combat duty in 
548 
Iraq and Afghanistan, mental health problems, and barriers to care. New England Journal of Medicine, 351(1), 
549 
13-22.Nock et al., 2014 
550 
2. Nock, M.K., Stein, M.B., Heeringa, S.G., Ursano, R.J., Colpe, L.J., Fullerton, C.S., Hwang, I., Naifeh, J.A., 
551 
Sampson, N.A., Schoenbaum, M., Zaslavsky, A.M., Kessler, R.C. (2014). Prevalence and correlates of suicidal 
552 
behavior among soldiers: Results from the Army Study to Assess Risk and Resilience in Servicemembers (Army 
553 
STARRS) JAMA Psychiatry, 71(5), 514-522 
554 
3. Gradus, J. L., Suvak., M. K., Wisco, B. E., Marx, B. P., & Resick, P. A. (2013). Treatment of posttraumatic stress 
555 
disorder reduces suicidal ideation. Depression and Anxiety, 30(10), 1046-1053. doi:10.1002/da.22117 
556 
4. Bryan, C. J., Clemans, T. A., Hernandez, Mintz, J., Peterson, A. L., Yarvis, J. S., . . . the STRONG STAR 
557 
Consortium. (2016). Evaluating potential iatrogenic suicide risk in trauma-focused group cognitive behavioral 
558 
therapy for the treatment of PTSD in active duty military personnel. Depression and Anxiety, 33(6), 549-557. 
559 
doi:10.1002/da.22456  
560 
5. Sloan, D. M., Marx, B. P., Lee, D. J., & Resick, P. A. (2018). A brief exposure-based treatment vs cognitive 
561 
processing therapy for posttraumatic stress disorder: A randomized noninferiority clinical trial. JAMA Psychiatry, 
562 
75(3):233-239. doi:10.1001/jamapsychiatry.2017.4249 
563 
6. Nock, M. K., Holmberg, E. B., Photos, V. I., & Michel, B. D. (2007). Self-Injurious Thoughts and Behaviors 
564 
Interview: development, reliability, and validity in an adolescent sample. Psychological Assessment, 19(3), 309-
565 
317. doi: 10.1037/1040-3590.19.3.309 
566 
7. Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The Clinician-
567 
Administered PTSD Scale for DSM-5 (CAPS-5) [Measurement Instrument]. Retrieved from the National Center 
568 
for PTSD website. 
569 
8. U.S. Department of Veterans Affairs. (2017). VA/DoD Clinical Practice Guidelines - Management of 
570 
Posttraumatic Stress Disorder and Acute Stress Reaction 2017. Washington D.C. Available at: 
571 
https://www.healthquality.va.gov/guidelines/MH/ptsd 
572 
9. Sloan, D. M., Marx, B. P., Bovin, M. J., Feinstein, B. A., & Gallagher, M. W. (2012). Written exposure as an 
573 
intervention for PTSD: A randomized controlled trial with motor vehicle accident survivors. Behaviour Research 
574 
and Therapy, 50, 627-635. doi: 10.1016/j.brat.2012.07.001 
575 
10. Bryan, C. J., Mintz, J., Clemans, T. A., Leeson, B., Burch, T. S., Williams, S. R., ... & Rudd, M. D. (2017a). Effect 
576 
of crisis response planning vs. contracts for safety on suicide risk in US Army Soldiers: A randomized clinical 
577 
trial. Journal of Affective Disorders, 212, 64-72. 
578 
11. Bryan, C.J., Mintz, J., Clemans, T.A., Burch, T.S., Leeson, B., Williams, S.R., & Rudd, M.D. (2017b). The effect 
579 
of crisis response planning on patient mood state and clinician decision-making: a randomized clinical trial with 
580 
acutely suicidal U.S. soldiers. Psychiatric Services. 
581 
12. Bryan, C. J. (2016). Treating PTSD within the context of heightened suicide risk. Current psychiatry reports, 
582 
18(8), 73. 
583 
13. Bryan, C.J., Grove, J.L., & Kimbrel, N.A. (2017). Theory-driven models of self-directed violence among 
584 
individuals with PTSD. Current Opinion in Psychology, 14, 12-17. 
585 
14. Foa, E. B., McLean, C. P., Zang, Y., Rosenfield, D., Yadin, E., Yarvis, J. S., Mintz, J., Young-McCaughan, S., 
586 
Borah, E. V., Dondanville, K. A., Fina, B. A., Hall-Clark, B. N., Lichner, T., Litz, B. T., Roache, J., Wright, E. C., & 
587 
Peterson, A. L., for the STRONG STAR Consortium. (2018). Effect of prolonged exposure therapy delivered over 
588 
2 seeks vs 8 seeks vs present centered therapy on PTSD severity in military personnel: A randomized clinical 
589 
trial. Journal of the American Medical Association, 319, 354-364. https://doi.org/10.1001/jama.2017.21242  
590 
15. Fredman, S. J., Macdonald, A., Monson, C. M., Rhoades, G. K., Dondanville, K. A., & the Consortium to Alleviate 
591 
PTSD (2018, November). An initial efficacy study of cognitive-behavioral conjoint therapy for PTSD delivered in 
592 
an intensive weekend format for military and veteran couples. In A. Macdonald (Chair), The flexible delivery of 
593 
cognitive-behavioral couple therapy for posttraumatic stress disorder to overcome barriers to care. Paper to be 
594 
presented at the annual meeting of the International Society for Traumatic Stress Studies, Washington, DC. 
595 
*Consortium to Alleviate PTSD group authors include (alphabetically): T. Blount, B. Fina, B. Hall-Clark, A. 
596 
Hancock, T. Keane, B. T. Litz, C. McGeary, J. Mintz, B. Niles, A. L. Peterson, P. A. Resick, J. D. Roache, S. 
597 
Young-McCaughan, J. Wachen, & J. S. Yarvis. 
598 
16. Peterson, A. L., Foa, E. B., Blount, T. H., McLean, C. P., Shah, D. V., Young-McCaughan, S., Litz, B. T., 
599 
Schobitz, R. P., Castillo, D. T., Rentz, T. O., Yarvis, J. S., Dondanville, K. A., Fina, B. A., Hall-Clark, B. N., 
600 
Brown, L. A., DeBeer, B. R., Jacoby, V. M., Hancock, A. K., Williamson, D. E., Evans, W. R., Synett, S., Straud, 
601 
C., Hansen, H. R., Meyer, E. C., Javors, M. A., Sharrieff, A.-F. M., Lara-Ruiz, J., Koch, L. M., Roache, J. D., 
602 
Mintz, J., & Keane, T. M.; for the Consortium to Alleviate PTSD. (2018). Intensive prolonged exposure therapy 
603 
for combat-related posttraumatic stress disorder: Design and methodology of a randomized clinical trial. 
604 
Contemporary Clinical Trials, 72, 12-136. DOI: https://doi.org/10.1016/j.cct.2018.07.016 
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17. Acierno, R., Knapp, R., Tuerk, P., Gilmore, A. K., Lejuez, C., Ruggiero, K., Muzzy, W., Egede, L., Hernandez-
606 
Tejada, M. A., & Foa, E. B. (2017). A non-inferiority trial of Prolonged Exposure for posttraumatic stress disorder: 
607 
In person versus home-based telehealth. Behaviour Research and Therapy, 89, 57-65. 
608 
https://doi.org/10.1016/j.brat.2016.11.009 
609 
18. Morland, L. A., Mackintosh, M., Glassman, L. H., Wells, S. Y., Thorp, S. R., Rauch, S. A. M., Cunningham, P. B., 
610 
Tuerk, P. W., Grubbs, K. M., Golshan, S., Sohn, M. J., & Acierno, R. (2019). Home-based delivery of variable 
611 
length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. Depression 
612 
and Anxiety,      https://doi.org/10.1002/da.22979 
613 
 
614 
11.1 Measurement Bibliography 
615 
 
616 
Batterham, P. J., Ftanou, M., Pirkis, J., Mackinnon, A. J., Beautrais, A., Fairweather-Schmidt, A. K., & Christensen, 
617 
H. (2014, December 15). A systematic review and evaluation of measures for suicidal ideation and behaviors in 
618 
population-based research. Psychological Assessment. Advance online publication. 
619 
http://dx.doi.org/10.1037/pas0000053 
620 
Bryan, C.J., Kanzler, K.E., Grieser, E., Martinez, A.,  Allison, S., McGerary, D. (2016). A Shortened Version of the 
621 
Suicide Cognitions Scale for Identifying Chronic Pain Patients at Risk for Suicide. Pain Practice. 
622 
17.10.1111/papr.12464. 
623 
Foa, E. B., Elhers, A., Clark, D. M., Tolin, D. F. & Orsillo, S. M. (1999). The Posttraumatic Cognitions Inventory 
624 
(PCTI). Psychological Assessments, 11, 303-314.Kirby, K. N., Petry, N. M., & Bickel, W. K. (1999). Heroin 
625 
addicts have higher discount rates for delayed rewards than non-drug-using controls. Journal of Experimental 
626 
Psychology: General, 128, 78-87.  
627 
Nock, M. K., Holmberg, E. B., Photos, V. I., & Michel, B. D. (2007). Self-Injurious Thoughts and Behaviors Interview: 
628 
Development, reliability, and validity in an adolescent sample. Psychological Assessment, 19, 309-317. 
629 
Schwab, K. A., Baker, G., Ivins, B., Sluss-Tiller, M., Lux, W., & Warden, D. (2006). The Brief Traumatic Brain Injury 
630 
Screen (BTBIS): Investigating the validity of a self-report instrument for detecting traumatic brain injury (TBI) in 
631 
troops returning from deployment in Afghanistan and Iraq. [Abstract]. Neurology, 66(5)(Supp. 2), A235. 
632 
Schwab, K. A., Ivins, B., Cramer, G., Johnson, W., Sluss-Tiller, M., Kiley, K., Lux, W. & Warden, D. (2006). 
633 
Screening for traumatic brain injury in troops returning from deployment in Afghanistan and Iraq: Initial 
634 
investigation of the usefulness of a short screening tool for traumatic brain injury. Journal of Head Trauma 
635 
Rehabilitation, 22(6), 377-389. 
636 
Vogt, D. S., Smith, B. N., King, L. A., King, D. W., Knight, J. A., & Vasterling, J. J. (2013). Deployment Risk and 
637 
Resilience Inventory-2 (DRRI-2): An updated tool for assessing psychosocial risk and resilience factors among 
638 
service members and veterans. Journal of Traumatic Stress, 26, 710-717.  
639 
Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., Marx, B.P., & Keane, T.M. (2013). The Clinician-
640 
Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at 
641 
www.ptsd.va.gov. 
642 
Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G., Marx, B. P., & Keane, T. M. (2013). The Life Events 
643 
Checklist for DSM-5 (LEC-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov. 
644 
Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist 
645 
for DSM-5 (PCL-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov. 
646 
 
647 
12.0 TIME REQUIRED TO COMPLETE THE RESEARCH (including data analysis).  Approximately 3 years from the 
648 
time participant recruitment starts.   
649 
   
650 
13.0 STUDY CLOSURE PROCEDURES   
651 
 
652 
At the completion of the study a protocol closure report will be submitted for review.  At the time of study closure, all links 
653 
between PHI and the study data will be destroyed unless the participant has also agreed to participation in the STRONG 
654 
STAR Repository approved by the UTHSCSA IRB (HSC20100475H).  Informed consent documents and the HIPAA 
655 
authorizations will be kept for 6 years past the closure of the study IAW 32CFR219 and IAW 45 CFR160-164, before 
656 
being destroyed. 
657 
 
658 
14.0 Funding.  
659 
• 
The DoD to the Military Suicide Research Consortium at Florida State University managed by the 
660 
Congressionally Directed Medical Research Program is funding this project. 
661 
• 
Florida State University then awarded a subcontract for this specific project to the Boston VA Research 
662 
Institute (BVARI), PI: Brian Marx PhD. 
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• 
BVARI in turn awarded a subcontract to UTHSCSA for this specific project, PI: Alan Peterson. 
664 
 
665 
15.0 Description of Assessments: 
666 
1. Supplemental Demographic Form_v1.0 :  The Demographics Form queries eight standard demographics and 
667 
military service information not part of the Military Suicide Research Consortium (MSRC) Common 
668 
Demographics (e. g., height, weight, military grade, type of military service, etc).   
669 
 
670 
2. Military Suicide Research Consortium (MSRC) Common Demographics: The MSRC Common Demographics 
671 
(CDem) were developed by the MSRC.  As a requirement of funding, the research team is required to administer 
672 
these questionnaire and upload a limited data set (with dates but without other patient identifiers) as a SPSS file 
673 
to the MSRC website. The MSRC Common Demographics is a 32 item self-report questionnaire compromised of 
674 
questions related to standard demographics (race, gender, age) and military service information (e.g., rank).    
675 
 
676 
3. Military Suicide Research Consortium (MSRC) Common Data Elements: The MSRC Data Elements (CDEs) 
677 
were developed by the MSRC.  As a requirement of funding, the research team is required to administer these 
678 
questionnaire and upload a limited data set (with dates but without other patient identifiers) as a SPSS file to the 
679 
MSRC website. The MSRC CDEs is a 91 item self-report questionnaire compromised of questions related to 
680 
self-injurious thoughts, behaviors and related psychopathology. 
681 
 
682 
 
683 
4. Health Interview: The original Health Care Utilization (HCU) is a 16-item questionnaire developed in 2000 for Dr. 
684 
Patricia A. Resick’s NIH grant, “Cognitive Processes in PTSD: Treatment II.” The questionnaire was based on 
685 
the 1999 Behavioral Risk Factor Surveillance System. The version that will be administered as part of the 
686 
STRONG STAR Consortium has been modified to be of increased relevance to active duty service personnel. 
687 
The measure includes items regarding use of mental health services, current psychiatric medication, past 
688 
psychiatric medication, hospitalization, and outpatient medical services, as well as items intended to assess 
689 
changes in participants’ military status. Tobacco/nicotine use will also be queried. 
690 
 
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5. Self-Injurious Thoughts and Behaviors Interview (SITBI): The SITBI (Nock, Holmberg, Photos, & Michel, 2007) is 
692 
a structured interview assessing the presence, frequency, and characteristics of self-injurious and suicidal 
693 
thoughts and behaviors. The SITBI will be administered by an Independent Evaluator, who will instruct the 
694 
participants to answer the questions based on their entire lifetime of experience. The SITBI has shown high 
695 
interrater reliability, test-retest reliability, and concurrent validity (Nock et al., 2007).  
696 
 
697 
6. Depressive Symptoms Index-Suicidality Subscale (DSI-SS):  The DSI-SS (Metalsky & Joiner, 1997) will be used 
698 
to assess current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses 
699 
on ideation, plans, perceived control over ideation, and impulses for suicide. It is being used as a core measure 
700 
in the Military Suicide Research Consortium. Scores on each item range from 0 to 3, with higher scores 
701 
reflecting greater severity of suicidal ideation. Instructions will instruct the participants to respond based on the 
702 
past two weeks (for baseline and follow up visits) or the past week (for interim assessment visits). A systematic 
703 
review of measures of suicidal ideation and behaviors found that the DSI-SS had evidence of excellent internal 
704 
consistency and concurrent validity (Batterham et al., 2014).   
705 
 
706 
7. The Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Weathers, Blake, Schnurr, Kaloupek, Marx, & 
707 
Keane, 2012): The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD (Weathers et al., 
708 
2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and 
709 
combines information about frequency and intensity for each of the 20 symptoms. Additional items that are not 
710 
included in the total score evaluate overall symptom duration, distress, impairment, dissociative symptoms, and 
711 
global ratings by the interviewer. Validation studies are nearly complete to establish the psychometric properties 
712 
of the CAPS-5 and findings will be reported in peer-reviewed publications. This interview is very similar to its 
713 
predecessor, the CAPS for DSM-IV, which has been considered the gold standard for evaluating PTSD and 
714 
demonstrated good reliability and validity (Weathers, Keane, & Davidson, 2001). In addition to reflecting 
715 
diagnostic changes for PTSD in DSM-5, the CAPS-5 differs from the CAPS in that frequency and intensity 
716 
ratings for each symptom are no longer scored separately, so the severity rating for each item determines 
717 
whether a symptom is present or not. Subscale scores are calculated by summing severity scores for items in 
718 
the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, 
719 
and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. 
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8. Life Events Checklist-5 (LEC-5): The LEC includes a list of 24 potentially traumatic life events commonly 
722 
associated with PTSD symptoms. The instrument was designed to facilitate the diagnosis of PTSD (Weathers, 
723 
Blake, Schnurr, Kaloupek, Marx, & Keane, 2013a).). In this study, the LEC-5 will also be used to identify the 
724 
index event and focus of the PTSD treatment. For each potentially traumatic life event, respondents rate their 
725 
experience of that event on a 5-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 
726 
4 =part of my job, 5= not sure, and 6 = does not apply). Each nominal point will be scored separately, as either 0 
727 
(=not endorsed by participant) or 1 (=endorsed by participant). 
728 
 
729 
9. PTSD CheckList-5 (PCL-5): The PCL-5 (Weathers, et al., 2010) is a 20-item self-report measure update of the 
730 
PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has 
731 
been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been 
732 
bothered by PTSD symptoms in the past month (for baseline and follow up assessments) or the past week (all 
733 
interim assessments) as a result of a specific life event.  Each item of the PCL-5 is scored on a five point scale 
734 
ranging from 0 “not at all”) to 4 (“extremely). 
735 
 
736 
10. Deployment Risk and Resiliency Inventory-2 (DRRI-2) Combat Experiences subscale and DRRI-2 Postbattle 
737 
Experiences subscales:: The DRRI-2 (Vogt, et al., 2013) is a suite of 17 individual scales that assess key 
738 
deployment-related risk and resilience factors with demonstrated implications for veterans’ long-term 
739 
health.  The Combat Experiences and Postbattle Experiences subscales will be used to assess stressful 
740 
deployment experiences. 
741 
 
742 
 
743 
11. Monetary-Choice Questionnaire (MCQ): The MCQ (Kirby et al., 1999) is a 27-item self-administered 
744 
questionnaire. For each item, the participant chooses between a smaller, immediate monetary reward and a 
745 
larger, delayed monetary reward. The measure is scored by calculating where the respondent’s answers place 
746 
him/her amid reference discounting curves, where placement amid steeper curves indicates higher levels of 
747 
impulsivity.  
748 
 
749 
12. Suicide Cognition Scale Short Form (SCS-S): The SCS-S is a 9-item self-report measure designed to assess 
750 
suicide-specific thoughts and belief, with demonstrated reliability and validity with chronic pain patients (Bryan et 
751 
al., 2016). The SCS-S evaluates how much an individual agrees with the suicide-related cognition. Scores on 
752 
each item range from 1-5, with higher scores reflecting greater severity.   
753 
 
754 
13. Posttraumatic Cognitions Inventory (PTCI):  The PTCI is a 36-item questionnaire that was developed to 
755 
determine how an individual views the trauma and its sequelae in an attempt to understand both how PTSD 
756 
develops and is maintained (Foa, Elhers, Clark, Tolin, & Orsillo, 1999).  Using an emotional processing theory, 
757 
Foa and her colleagues (1999) have suggested that PTSD is a consequence of disruptions in the normal 
758 
processes of recovery when an individual has excessively rigid concepts about self and world rendering the 
759 
person vulnerable if a traumatic event occurs.  Thus the PTCI was developed as a measure of trauma-related 
760 
thoughts and beliefs.  It is comprised of three subscales (Negative Cognitions about the Self, Negative 
761 
Cognitions about the World, and Self-Blame).  The measure was tested in almost 600 adult volunteers recruited 
762 
from two university PTSD treatment clinics as well as a university community.  Approximately 65% (n=392) of 
763 
individuals reported having experienced a trauma in which their own life or that of another person was perceived 
764 
to be in danger and their response at the time included intense terror, horror, or helplessness (Criterion A event).  
765 
The remaining 35% (n=162) denied such a traumatic experience.  Of those who had experienced a trauma, 170 
766 
had PTSD symptoms of at least moderate severity while the remaining 185 reported a low symptom severity.  
767 
The three subscales of the PTCI demonstrated internal consistency with alpha coefficients ranging from 0.86 to 
768 
0.97.  Convergent validity was demonstrated comparing the PTCI to appropriate subscales of the World 
769 
Assumptions Scale and Personal Beliefs and Reactions Scale.  Significant correlations between the appropriate 
770 
subscales ranged from 0.20 to 0.85.  The PTCI was able to differentiate individuals with and without PTSD 
771 
demonstrating discriminate validity (sensitivity = 0.78, specificity = 0.93).  Test–retest reliability for each of the 
772 
three subscales at a 1-week interval ranged from 0.75 to 0.89 and for a 3-week interval ranged from 0.80 to 
773 
0.86. 
774