DBT Skills Groups for Veterans at High Risk for Suicide Attempt

Suicide, Attempted Clinical Trial

Official title:

A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000749
• Other study ID #: SDR 20-136
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: Suzanne Decker, PhD
• Phone: (203) 932-5711
• Email: suzanne.decker[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 suicide attempt.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran eligible for VHA care at participating site

• two or more suicide attempts in lifetime, with one in past 6 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 110 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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• 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.
• VHA treatment as usual
VHA treatment as usual for Veterans at risk for suicide attempt

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque, NM	Albuquerque	New Mexico
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia-Suicide Severity Rating Scale	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.	Up to 18 month follow-up
Secondary	Change in Emotion dysregulation	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.	Up to18 month follow-up
Secondary	Coping	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.	Up to 18 month follow-up