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Active, Not Recruiting

NCT Number: NCT05000749

DBT Skills Groups 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Emotional Regulation Self-Control Self-Injurious Behavior Social Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT-SG

Behavioral

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

Behavioral

VHA treatment as usual for Veterans at risk for suicide attempt

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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