Written Exposure Therapy for Suicide Prevention

Suicide, Attempted Clinical Trial

Official title:

Written Exposure Therapy for Suicide Prevention (WET-SP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05878795
• Other study ID #: H-43849
• Secondary ID: W81XWH-22-1-1059
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Boston University
• Contact: Brian P Marx, PhD
• Phone: 857-364-6071
• Email: bpmarx[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention
• Suicide Threat
• Suicide, Attempted

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Center San Antonio	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	School of Medicine, Anschutz Medical Campus, Colorado University, The University of Texas Health Science Center at San Antonio, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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