Clinical trial NCT04225130: Decreasing Suicide Risk Among Service Members With Posttraumatic Stress
Official title: Decreasing Suicide Risk Among Service Members With Posttraumatic Stress Using Written Exposure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Posttraumatic Stress Disorder
Lead sponsor: Boston VA Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2020-01-13
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Adult (18 years or older) service members hospitalized at Carl R Darnall Army Medical Center for SI/suicide plan or attempt.
* Symptoms of posttraumatic stress (PTS) of at least moderate severity (total scores \> 20) confirmed by assessor using the CAPS-5.
* Speak, read, and write English.

Exclusion Criteria:

* Active psychosis.
* The presence of moderate to severe cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires).
* The presence of any factor that may impair an individual's ability to comprehend and effectively participate in the study, including the presence of extreme agitation or violent behavior.

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale Scores
timeFrame: baseline, 1-month, 4-month follow-up
measure: Change in Self-Injurious Thoughts and Behaviors Interview Scores
timeFrame: Baseline, 1-month, 4-month follow-up
measure: Change in medical record outcomes
timeFrame: Baseline, 1-month, 4-month follow-up
measure: Change physical and mental health assessed by Military Suicide Research Consortium Common Data Elements
timeFrame: Baseline, 1-month, 4-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Hood
country: United States
facility: Carl R Darnell Army Medical Center
state: Texas
Study officials:
References: