Clinical trial NCT05000749: DBT Skills Groups for Veterans at High Risk for Suicide Attempt
Official title: A Hybrid Effectiveness-Implementation Multisite Trial of a Dialectical Behavior Therapy Skills Group for Veterans at High-Risk for Suicide Attempt
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Keywords: suicide, attempted
dialectical behavior therapy
suicide attempt
emotion regulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-11
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two study conditions for the duration of the study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Emotion dysregulation
timeFrame: Up to18 month follow-up
Secondary outcomes:
measure: Coping
timeFrame: Up to 18 month follow-up
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Up to 18 month follow-up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque, NM
state: New Mexico
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Suzanne Decker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Steve Martino, PhD
role: PRINCIPAL_INVESTIGATOR
References: