Written Exposure Therapy for Suicide Prevention

Written Exposure Therapy for Suicide Prevention (WET-SP)

Military service members admitted to inpatient psychiatry for self-injurious thoughts and behaviors (SITBs) represent an at-risk group for continued SITBs and rehospitalizations in the post-discharge period. However, there is an absence of evidence-based interventions designed to be delivered on inpatient psychiatric units to reduce the risk of post-discharge SITBs. To address this gap, the investigator's research group developed Written Exposure Therapy for Suicide Prevention (WET-SP), a brief, scalable, suicide-specific psychotherapy based on the written disclosure paradigm. Written disclosure, in which an individual writes about a personally stressful experience and the related thoughts and feelings, yields improvements across physical and psychiatric domains. Pilot data suggest that written exposure also yields reductions in SITBs. Yet, no study has adapted the written exposure paradigm specifically to target the amelioration of distress associated with suicidal crises and examined whether implementing WET-SP reduces the risk of subsequent SITBs and suicide-related hospitalizations.

The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacy of WET-SP, in reducing the incidence and severity of SITBs in active duty military service members following a psychiatric hospitalization due to suicidal ideation, suicide plans, or a suicide attempt. Secondary objectives are to evaluate a potential mechanism of change (i.e., decreases in thwarted belongingness [cf. social disconnectedness]) and moderator of outcomes (i.e., arc of narrative [cf. linguistical parameters of the written narratives generated during treatment]). Participants randomized to WET-SP + TAU will receive five sessions of WET-SP delivered by the study team during their psychiatric hospitalization plus treatment-as-usual (TAU). Participants randomized to TAU will receive daily contact and patient-centered care delivered by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers). TAU includes psychiatric assessment, initial stabilization, nurse case management, medication management, treatment of medical comorbidities, group and individual therapy, and discharge planning. Outcome assessments will be administered at pretreatment, posttreatment, and 10-, 20-, and 30-week follow-ups.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicide, Attempted; Suicide Threat
• Intervention / Treatment: Behavioral: WET-SP; Behavioral: TAU

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian P Marx, PhD; Phone Number: 857-364-6071; Email: bpmarx@bu.edu
• Study Contact Backup: Name: Denise M Sloan, PhD; Phone Number: 857-364-6333; Email: dsloan@bu.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Center San Antonio
      • Contact: Alan Peterson, PhD; Phone Number: 210-562-6700; Email: Petersona3@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current active duty military service member
• Admitted to Carl R. Darnall Army Medical Center (CRDAMC) for suicidal thoughts, a suicide plan, or a suicide attempt
• Elevated levels of suicidal ideation severity in the past two weeks, as indicated by a score >3 on the Depressive Symptom Index-Suicidality Subscale (DSI-SS; Joiner et al., 2002; Stanley et al., 2021)
• Ability to read, write, and speak English

Exclusion Criteria:

• Active psychosis as the priority of care for hospitalization
• Moderate or greater cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires)
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written Exposure Therapy-for Suicide Prevention (WET-SP) +TAU; Participants randomized into this arm will be offered WET-SP which will consist of 5 treatment sessions, conducted daily while the participant is hospitalized, allowing for the largest dose of treatment possible while inpatient. If a patient is discharged prior to the completion of WET-SP, the remaining sessions will be conducted in outpatient sessions. Participants in this arm will also be offered TAU.	Behavioral: WET-SP; WET-SP will consist of 5 treatment sessions; the first session lasting about one hour and each subsequent session lasting approximately 45 minutes. Each session will include a 30-minute written exposure exercise. The participant will be given general instructions for completing the narrative writings and specific instructions for completing the first session. Participants will be instructed to write about the same suicidal crisis during each session. The therapist will emphasize the importance of delving into their deepest emotions surrounding the suicidal crisis as well as the importance of writing detailed information about the crisis. Following writing, the therapist and the participant will process the writing experience. Subsequent sessions involve the therapist iteratively providing feedback to the patient regarding their writing from the previous session.; Behavioral: TAU; TAU includes initial psychiatric stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily throughout the duration of hospitalization and have structured times for psychoeducation groups, case management, medication management, hygiene, and meals.
Active Comparator: Treatment as usual (TAU); Participants randomized into this arm will be offered TAU which 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). Participants will engage with the provider team daily throughout the duration of hospitalization.	Behavioral: TAU; TAU includes initial psychiatric stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily throughout the duration of hospitalization and have structured times for psychoeducation groups, case management, medication management, hygiene, and meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Suicidal ideation (SI)	Measured by the Depressive Symptom Index-Suicidality Subscale (DSI-SS) which is a four-item self-report focusing on frequency and intensity of suicidal thoughts and urges during the past 2 weeks. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Total scores can range from 0 to 12, with higher scores representing increased severity of suicidal ideation.	Baseline, 10 weeks
SI at 20 weeks	Measured by the Depressive Symptom Index-Suicidality Subscale (DSI-SS) which is a four-item self-report focusing on frequency and intensity of suicidal thoughts and urges during the past 2 weeks. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Total scores can range from 0 to 12, with higher scores representing increased severity of suicidal ideation.	20 weeks
SI at 30 weeks	Measured by the Depressive Symptom Index-Suicidality Subscale (DSI-SS) which is a four-item self-report focusing on frequency and intensity of suicidal thoughts and urges during the past 2 weeks. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Total scores can range from 0 to 12, with higher scores representing increased severity of suicidal ideation.	30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Most severe SI	The most severe SI since the last assessment will be measured using the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) which is a clinical interview of the presence, frequency, and characteristics of suicide and self-harming thoughts and behaviors.	Baseline,10 weeks, 20 weeks, 30 weeks

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: United States Department of Defense; The University of Texas Health Science Center at San Antonio; School of Medicine, Anschutz Medical Campus, Colorado University
• Investigators: Principal Investigator: Brian P Marx, PhD, Dept of Psychiatry, Chobanian & Avedisian BU School of Medicine and VA Boston Healthcare System

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Self-injurious thoughts and behaviors (SITBs); Written Exposure Therapy for Suicide Prevention (WET-SP); Military service members; Treatment as usual (TAU)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted; Suicide Prevention
• Other Study ID Numbers: H-43849; W81XWH-22-1-1059 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No