Decreasing Suicide Risk Among Service Members With Posttraumatic Stress

NCT04225130 | Completed DMC

• 1 other identifier: W81XWH-16-2-0003
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline, 1-month, 4-month follow-up

Study Arms (2)

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.

Behavioral: Written Exposure Therapy -for Suicide

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.

Behavioral: Treatment as Usual

Interventions

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.

Also known as: WET-S

Written Exposure Therapy -for Suicide

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.

Also known as: TAU

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Carl R Darnell Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Related Publications (1)

• 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.

  PMID: 40052305 DERIVED

MeSH Terms

Conditions

Suicide; Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Behavioral Science Division, National Center for PTSD

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: January 9, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.

Locations

US (1)