Clinical trial NCT05878795: Written Exposure Therapy for Suicide Prevention
Official title: Written Exposure Therapy for Suicide Prevention (WET-SP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicide Threat
Keywords: Self-injurious thoughts and behaviors (SITBs)
Written Exposure Therapy for Suicide Prevention (WET-SP)
Military service members
Treatment as usual (TAU)
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: The University of Texas Health Science Center at San Antonio
name: University of Colorado, Denver
First posted: 2023-05-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Current active duty military service member, veteran, and beneficiaries
* 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)
* 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

Primary outcomes:
measure: Change in Suicidal ideation (SI)
timeFrame: Baseline, 10 weeks
measure: SI at 20 weeks
timeFrame: 20 weeks
measure: SI at 30 weeks
timeFrame: 30 weeks
Secondary outcomes:
measure: Most severe SI
timeFrame: Baseline,10 weeks, 20 weeks, 30 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Center San Antonio
state: Texas
Study officials:
affiliation: Dept of Psychiatry, Chobanian & Avedisian BU School of Medicine and VA Boston Healthcare System
name: Brian P Marx, PhD
role: PRINCIPAL_INVESTIGATOR
References: