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Written Exposure Therapy for Suicide Prevention

Primary Purpose

Suicide, Attempted, Suicide Threat

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WET-SP
TAU
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring Self-injurious thoughts and behaviors (SITBs), Written Exposure Therapy for Suicide Prevention (WET-SP), Military service members, Treatment as usual (TAU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Texas Health Center San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Written Exposure Therapy-for Suicide Prevention (WET-SP) +TAU

Treatment as usual (TAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 18, 2023
Last Updated
September 27, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05878795
Brief Title
Written Exposure Therapy for Suicide Prevention
Official Title
Written Exposure Therapy for Suicide Prevention (WET-SP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Written Exposure Therapy-for Suicide Prevention (WET-SP) +TAU
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WET-SP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Suicidal ideation (SI)
Description
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.
Time Frame
Baseline, 10 weeks
Title
SI at 20 weeks
Description
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.
Time Frame
20 weeks
Title
SI at 30 weeks
Description
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.
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Most severe SI
Description
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.
Time Frame
Baseline,10 weeks, 20 weeks, 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian P Marx, PhD
Phone
857-364-6071
Email
bpmarx@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denise M Sloan, PhD
Phone
857-364-6333
Email
dsloan@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian P Marx, PhD
Organizational Affiliation
Dept of Psychiatry, Chobanian & Avedisian BU School of Medicine and VA Boston Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Peterson, PhD
Phone
210-562-6700
Email
Petersona3@uthscsa.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Written Exposure Therapy for Suicide Prevention

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