DBT Skills Groups for Veterans at High Risk for Suicide Attempt

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Suicide, Attempted

Intervention / Treatment
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* Behavioral: DBT-SG
* Behavioral: VHA treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two study conditions for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBT-SG plus VHA treatment as usual<br>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-SG<br>* 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.<br>Behavioral: VHA treatment as usual<br>* VHA treatment as usual for Veterans at risk for suicide attempt<br>|
| Active Comparator: VHA treatment as usual<br>VHA treatment as usual for Veterans at risk for suicide attempt | Behavioral: VHA treatment as usual<br>* VHA treatment as usual for Veterans at risk for suicide attempt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suicide, attempted, dialectical behavior therapy, suicide attempt, emotion regulation