Written Exposure Therapy for Suicide Prevention

Sponsor

Boston University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05878795

Collaborator

United States Department of Defense (U.S. Fed), The University of Texas Health Science Center at San Antonio (Other), School of Medicine, Anschutz Medical Campus, Colorado University (Other)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide, Attempted Suicide Threat	Behavioral: WET-SP Behavioral: TAU	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Written Exposure Therapy for Suicide Prevention (WET-SP)

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change in Suicidal ideation (SI) [Baseline, 10 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.
SI at 20 weeks [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.
SI at 30 weeks [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.

Secondary Outcome Measures

Most severe SI [Baseline,10 weeks, 20 weeks, 30 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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