Decreasing Suicide Risk Among Service Members With Posttraumatic Stress

NCT ID: NCT04225130

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2022-12-31

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.

Conditions

Suicide; Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Written Exposure Therapy -for Suicide

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.

Group Type: EXPERIMENTAL

Written Exposure Therapy -for Suicide

Intervention Type: 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.

Treatment as Usual

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: 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.

Interventions

Written Exposure Therapy -for Suicide

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

WET-S; TAU

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Boston VA Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Brian Marx, PH.D.

Deputy Director, Behavioral Science Division, National Center for PTSD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Carl R Darnell Army Medical Center

Fort Hood, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40052305 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-16-2-0003

Identifier Type: -

Identifier Source: org_study_id