NCT05000749

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2023Feb 2027

First Submitted

Initial submission to the registry

August 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

August 3, 2021

Last Update Submit

January 20, 2026

Conditions

Suicide, Attempted

Keywords

suicide, attempteddialectical behavior therapysuicide attemptemotion regulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Coping

    Up to 18 month follow-up

  • Columbia-Suicide Severity Rating Scale

    Up to 18 month follow-up

Study Arms (2)

DBT-SG plus VHA treatment as usual

EXPERIMENTAL

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.

Behavioral: DBT-SGBehavioral: VHA treatment as usual

VHA treatment as usual

ACTIVE COMPARATOR

VHA treatment as usual for Veterans at risk for suicide attempt

Behavioral: VHA treatment as usual

Interventions

DBT-SGBEHAVIORAL

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.

DBT-SG plus VHA treatment as usual
VHA treatment as usualBEHAVIORAL

VHA treatment as usual for Veterans at risk for suicide attempt

DBT-SG plus VHA treatment as usualVHA treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

Related Publications (2)

  • 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.

    PMID: 39923893DERIVED

  • 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.

    PMID: 39655211DERIVED

MeSH Terms

Conditions

Suicide, AttemptedEmotional Regulation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • Suzanne Decker, PhD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

  • Steve Martino, PhD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will be masked to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two study conditions for the duration of the study.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 11, 2021

Study Start

April 30, 2023

Primary Completion (Estimated)

February 26, 2027

Study Completion (Estimated)

February 26, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(5)