- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05000749
DBT Skills Groups for Veterans at High Risk for Suicide Attempt
January 20, 2026 updated by: VA Office of Research and Development
A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92161-0002
- VA San Diego Healthcare System, San Diego, CA
-
-
Connecticut
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West Haven, Connecticut, United States, 06516-2770
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
-
-
Florida
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Tampa, Florida, United States, 33612
- James A. Haley Veterans' Hospital, Tampa, FL
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87108-5153
- New Mexico VA Health Care System, Albuquerque, NM
-
-
Ohio
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Cleveland, Ohio, United States, 44106-1702
- Louis Stokes VA Medical Center, Cleveland, OH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DBT-SG plus 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.
|
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 for Veterans at risk for suicide attempt
|
|
Active Comparator: VHA treatment as usual
VHA treatment as usual for Veterans at risk for suicide attempt
|
VHA treatment as usual for Veterans at risk for suicide attempt
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Emotion dysregulation
Time Frame: 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.
|
Up to18 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Columbia-Suicide Severity Rating Scale
Time Frame: 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.
|
Up to 18 month follow-up
|
|
Coping
Time Frame: 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.
|
Up to 18 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steve Martino, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Principal Investigator: Suzanne Decker, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Decker SE, Kroll-Desrosiers A, Mattocks KM, Aunon FM, Galliford E, DeRycke EC, Doran N, Baird S, Rielage JK, Ridley J, Bannister J, Giovannelli TS, Fuehrlein BS, Shriver C, Spana E, Honsberger M, Demirelli SA, Shest E, Landes SJ, Goodman M, Martino S. Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt. Contemp Clin Trials. 2025 Apr;151:107828. doi: 10.1016/j.cct.2025.107828. Epub 2025 Feb 7.
- Decker SE, Kroll-Desrosiers A, Mattocks K, Aunon FM, Galliford E, Doran N, Baird S, Rielage JK, Ridley J, Bannister J, Giovannelli TS, Landes SJ, Goodman M, Walker L, DeRycke E, Shriver C, Spana E, Honsberger M, Brown H, Demirelli S, Shest E, Martino S. Mixed-methods formative evaluation of implementing an adapted suicide prevention treatment: Dialectical Behavior Therapy Skills Groups in the Veterans Health Administration. Front Psychiatry. 2024 Nov 25;15:1495102. doi: 10.3389/fpsyt.2024.1495102. eCollection 2024.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2023
Primary Completion (Estimated)
February 26, 2027
Study Completion (Estimated)
February 26, 2027
Study Registration Dates
First Submitted
August 3, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 11, 2021
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR 20-136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Study data will include sensitive information about Veteran suicide risk.
In consultation with the VACHS Research Office, the investigators elect not to share final data sets for this reason except as required under FOIA.
Data will be preserved at VACHS on secure electronic servers behind the VA firewall, and made available for further study or validation by qualified individuals with VA IRB approval.
Contact information for the corresponding mPI will be included in publications to facilitate such requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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