Decreasing Suicide Risk Among Service Members With Posttraumatic Stress

Posttraumatic Stress Disorder Clinical Trial

Official title: Decreasing Suicide Risk Among Service Members With Posttraumatic Stress Using Written Exposure Therapy

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Suicide

• NCT number: NCT04225130
• Study type: Interventional
• Source: Boston VA Research Institute, Inc.
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Completion date: December 31, 2022