Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Texas Health Science Center at San Antonio | OTHER |
Not provided
Not provided
Not provided
Not provided
In this study, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
This study aims to compare a new formulation of WET referred to as WET-for suicide (WET-S) that includes crisis response planning + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTS admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas.
Aim 1: Determine if WET-S reduces the presence, frequency, and severity of suicidal ideation, suicide plans, suicide gestures, suicide attempts, non-suicidal self-injurious behaviors, and rehospitalization for suicidality.
Aim 2: Determine if WET-S + TAU reduces PTS symptom severity among service members admitted to an acute psychiatric inpatient unit for SI and/or attempt compared with TAU.
Aim 3: Determine if reductions in PTS symptoms mediate the association between treatment condition and suicide-related outcomes (suicidal ideation, plans, gestures, attempts, non-suicidal self-injurious behaviors, and rehospitalizations).
Aim 4: Develop a tool kit for WET-S implementation through a needs assessment with key stakeholders and evaluation of contextual factors among DoD inpatient facilities to determine readiness for successful implementation of WET-S.
Study investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.
Data will be collected in Texas. Investigators conservatively anticipate enrollment of approximately 140 service members to achieve a final sample size of 124 (n = 62 per condition) after accounting for 15% attrition. CRDAMC receives approximately 4500 admissions each year for SI/attempt. TAU on the inpatient unit consists of crisis management and stabilization. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Written Exposure Therapy -for Suicide | Experimental | Written Exposure Therapy-for Suicide (WET-S) consists of 5 treatment sessions. Each session includes a written exposure exercise. It also includes CRP. Participants assigned to WET-S will complete the CRP prior to beginning their writing in session 1. Patient use of the CRP since the previous session will be briefly reviewed at the start of each WET-S session to manage safety and problem solve fluctuations in risk during treatment. |
|
| Treatment as Usual | Active Comparator | The TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team. TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written Exposure Therapy -for Suicide | Behavioral | The first session will consist of the therapist educating the participant about common reactions to trauma and providing information regarding the rationale of WET-S as a treatment for PTSD. The participant will then be given general instructions for completing the trauma narratives, specific instructions for completing the first session, and will then complete the first (30 minutes) narrative writing session. Participants will be instructed to write about the same trauma experience during each session. The importance of delving into their deepest emotions surrounding the trauma event is emphasized. All WET-S sessions will take place in a private room and begin with the therapist reading the specific writing instructions for that session and then leaving the instructions with the participant while 30-minute writing session is completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered PTSD Scale Scores | The CAPS-5 is a structured diagnostic interview and gold standard for assessing PTSD. It provides a dichotomous PTSD diagnosis and overall symptom severity score. Scores range from 0 to 80, with greater scores signifying more severe PTSD symptoms. | baseline, 1-month, 4-month follow-up |
| Change in Self-Injurious Thoughts and Behaviors Interview Scores | The SITBI is a structured interview that assesses the presence (lifetime, past year, past month), frequency, severity, and characteristics of five types of SITB: (a) suicidal ideation, (b) suicide plans, (c) suicide gestures, (d) suicide attempts, and (e) non-suicidal self-injury. The SITBI assesses the frequency of each type of thought or behavior in the respondent's lifetime, past year, and past month, as well as the age of onset of each thought or behavior endorsed. The SITBI also assesses the severity of each thought or behavior endorsed on a scale from 0 (low/little) to 4 (very much/severe) scale, on average and at the worst point at each of those time frames. | Baseline, 1-month, 4-month follow-up |
| Change in medical record outcomes | At baseline and each follow-up assessment, study staff will access participants' medical record to obtain information about current and past mental health treatment, current and past psychiatric diagnoses, current and past psychiatric medication, and history of suicidal thoughts and behaviors. If applicable, date of admission(s) to inpatient psychiatric unit, chief complaint at the time of admission(s), details of psychiatric stay(s), and length of stay(s) will also be obtained. Changes in any of these variables from baseline to follow-up will be recorded. | Baseline, 1-month, 4-month follow-up |
| Change physical and mental health assessed by Military Suicide Research Consortium Common Data Elements | Participants will provide self-report information about their physical and mental health and behaviors at each time point. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R Darnell Army Medical Center | Fort Hood | Texas | 76544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40052305 | Derived | Kearns JC, Straud CL, Stanley IH, Sloan DM, Fina BA, Young-McCaughan S, Tyler HC, Kaplan AM, Blankenship AE, Schrader CC, Green VR, Bryan CJ, Peterson AL, Marx BP; STRONG STAR Consortium. Written Exposure Therapy for Posttraumatic Stress Symptoms and Suicide Risk: A Randomized Controlled Trial With High-Risk Patients Admitted to a Military Inpatient Psychiatric Unit. Suicide Life Threat Behav. 2025 Apr;55(2):e70008. doi: 10.1111/sltb.70008. |
Not provided
Not provided
De-identified data from study participants will be prepared and stored in the Military Suicide Research Consortium data repository, where it can then be accessed by interested researchers.
Not provided
Per the agreement with MSRC, the data will be placed in the repository periodically. Following completion of the study and publication of papers focused on primary study aims, the data will be available. There is no time limit for how long it will be available.
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2022 | Sep 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2022 | Sep 8, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Treatment as Usual | Behavioral | The TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers, behavioral health techs). TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily. |
|
|
| Baseline, 1-month, 4-month follow-up |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |