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DBT Skills Groups for Veterans at High Risk for Suicide Attempt

Primary Purpose

Suicide, Attempted

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DBT-SG

VHA treatment as usual

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring suicide, attempted, dialectical behavior therapy, suicide attempt, emotion regulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA San Diego Healthcare System, San Diego, CARecruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
James A. Haley Veterans' Hospital, Tampa, FLRecruiting
New Mexico VA Health Care System, Albuquerque, NMRecruiting
Louis Stokes VA Medical Center, Cleveland, OHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DBT-SG plus VHA treatment as usual

VHA treatment as usual

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05000749

First Posted

August 3, 2021

Last Updated

July 31, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT05000749

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2023 (Actual)

Primary Completion Date

December 30, 2026 (Anticipated)

Study Completion Date

December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 suicide attempt.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicide, Attempted

Keywords

suicide, attempted, dialectical behavior therapy, suicide attempt, emotion regulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomly assigned to one of two study conditions for the duration of the study.

Masking

Outcomes Assessor

Masking Description

Outcomes assessors will be masked to study condition.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DBT-SG plus VHA treatment as usual

Arm Type

Experimental

Arm Description

Arm Title

VHA treatment as usual

Arm Type

Active Comparator

Arm Description

VHA treatment as usual for Veterans at risk for suicide attempt

Intervention Type

Behavioral

Intervention Name(s)

DBT-SG

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

VHA treatment as usual

Intervention Description

VHA treatment as usual for Veterans at risk for suicide attempt

Primary Outcome Measure Information:

Title

Columbia-Suicide Severity Rating Scale

Description

Time Frame

Up to 18 month follow-up

Secondary Outcome Measure Information:

Title

Change in Emotion dysregulation

Description

Time Frame

Up to18 month follow-up

Title

Coping

Description

Time Frame

Up to 18 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne Decker, PhD

Phone

(203) 932-5711

Ext

3153

suzanne.decker@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Steve Martino, PhD

Phone

(203) 932-5711

Ext

2468

Steve.Martino@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne Decker, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steve Martino, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA San Diego Healthcare System, San Diego, CA

City

San Diego

State/Province

California

ZIP/Postal Code

92161-0002

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neal M Doran, PhD

Phone

858-552-8585

Ext

2421

Neal.Doran@va.gov

First Name & Middle Initial & Last Name & Degree

Neal M Doran, PhD

Facility Name

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

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516-2770

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

James A. Haley Veterans' Hospital, Tampa, FL

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny A Bannister

Phone

813-972-2000

Jenny.Bannister@va.gov

First Name & Middle Initial & Last Name & Degree

Jenny A Bannister

First Name & Middle Initial & Last Name & Degree

Thorayya S Giovannelli

Facility Name

New Mexico VA Health Care System, Albuquerque, NM

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108-5153

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer K Rielage

Phone

505-265-1711

Ext

2237

Jennifer.Rielage@va.gov

First Name & Middle Initial & Last Name & Degree

Jennifer K Rielage

Facility Name

Louis Stokes VA Medical Center, Cleveland, OH

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-1702

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Josephine A Ridley

Phone

216-791-3800

Ext

62903

Josephine.Ridley@va.gov

First Name & Middle Initial & Last Name & Degree

Josephine A Ridley

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

DBT Skills Groups for Veterans at High Risk for Suicide Attempt

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