DBT Skills Groups for Veterans at High Risk for Suicide Attempt

Not Applicable

Recruiting

• Conditions: Suicide, Attempted
• Interventions: Behavioral: DBT-SG; Behavioral: VHA treatment as usual

• Registration Number: NCT05000749
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Veteran suicide death is a national crisis. Risk factors include emotion dysregulation, which occurs across mental health disorders. Dialectical behavior therapy (DBT) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at VHA. A more efficient evidence-based DBT Skills Group (DBT-SG) is associated with reduced suicidal ideation and emotion dysregulation and likely more feasible to implement at VHA. This is a randomized controlled trial to test whether DBT-SG in addition to VHA treatment-as-usual, compared to only VHA treatment-as-usual, reduces Veteran emotion dysregulation.

Detailed Description

This is a randomized controlled trial at four VHA medical centers. Veterans will be randomized to VHA treatment-as-usual or VHA treatment-as-usual plus DBT-SG.

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2023-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18
• Primary Completion: 2027-02-26
• Study Completion: 2027-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Veteran eligible for VHA care at participating site
• two or more suicide attempts in lifetime, with one in past 12 months, on Columbia-Suicide Severity Rating Scale (C-SSRS)
• current suicidal ideation (endorsing a suicidal ideation scale of at least 1 [passive ideation] on C-SSRS
• emotion dysregulation (score 95 or greater on DERS)
• can attend group sessions
• willing to provide contact information for at least one person who can help locate the participant if study staff are unable to contact them (information for three contact persons will be requested; a participant must provide at least one contact person's information to be included in the study)
• access to telephone; if insufficient access to videoteleconference and local facility is using remote procedures for study, willing to request access to VA-provided device

Exclusion Criteria

• significant cognitive impairment (score < 28 on modified Telephone Interview for Cognitive Status (mTICS)
• inability to read English or communicate in spoken and written English
• plan to move away or be unavailable in the next 18 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBT-SG plus VHA treatment as usual	VHA treatment as usual	Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness.
VHA treatment as usual	VHA treatment as usual	VHA treatment as usual for Veterans at risk for suicide attempt
DBT-SG plus VHA treatment as usual	DBT-SG	Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness.

Primary Outcome Measures

Name	Time	Method
Change in Emotion dysregulation	Up to18 month follow-up	Emotion dysregulation will be assessed with the Difficulties in Emotion Regulation Scale, a self-report measure. The scale ranges 36-180 with a higher score indicating greater difficulties in emotion regulation.

Secondary Outcome Measures

Name	Time	Method
Coping	Up to 18 month follow-up	Coping skills will be assessed with the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL), a self-report measure. The mean score ranges 0-3 with a higher score indicating greater use of coping strategies.
Columbia-Suicide Severity Rating Scale	Up to 18 month follow-up	The Columbia-Suicide Severity Rating Scale is a widely used interview measure of suicide risk. The number of suicide attempts during 18month follow-up will be reported (range 0 to infinity), with a higher score indicating more suicide attempts.

Trial Locations

Locations (5)

Louis Stokes VA Medical Center, Cleveland, OH; 🇺🇸 Cleveland, Ohio, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

James A. Haley Veterans' Hospital, Tampa, FL; 🇺🇸 Tampa, Florida, United States

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States

New Mexico VA Health Care System, Albuquerque, NM; 🇺🇸 Albuquerque, New Mexico, United States