Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders
2 other identifiers
interventional
300
1 country
3
Brief Summary
The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention compared to a Supportive Psycho-educational Control (SPC) condition in reducing the frequency and intensity of suicidal thoughts and behaviors in Veterans with Substance Use Disorders (SUDs) over a two-year follow-up period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2020
CompletedSeptember 23, 2022
September 1, 2022
5 years
May 1, 2015
September 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in frequency and intensity of suicidal thoughts and suicide attempts
This will be measured using the Columbia Suicide Severity Rating Scale (CSS-RS) and a modified version of the Time Line Follow-Back (TLFB).
Change over study time period [Baseline, 1-, 3-, 6-, 12-, 18-, and 24-months]
Study Arms (2)
Cognitive Behavioral Therapy (CBT)
EXPERIMENTALThe CBT condition will cover topics such as orienting the patient to the cognitive model of suicidal thoughts, plans and behaviors and the role of substance use in increasing the likelihood of suicidal behaviors and presenting tools to help patients better manage responses to suicide-related triggers.
Supportive Psycho-education (SPC)
ACTIVE COMPARATORThe SPC condition is designed to match the CBT condition in terms of level of attention and the non-specific aspects of receiving support for a suicidal crisis and substance misuse. Specific content related to suicide risk will consist of general information about suicide-related resources available, while content related to substance use is based on a modified psycho-educational attention control treatment for alcoholism. The sessions will help patients to better understand the resources available during a suicidal crisis and how substance use impacts in their life. However, topics related to identifying thoughts and behaviors associated with suicidal crises and possible coping mechanisms will not be a part of the formal content of these SPC sessions.
Interventions
The therapeutic intervention group consists of 8, one-hour individual therapy sessions delivered over the course of 3-4 weeks with a trained CBT therapist. These sessions are designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.
This active control condition consists of 8, one-hour individual therapy sessions delivered over the course of 3-4 weeks with a trained therapist. The sessions will provide detailed information about substance use, suicide risk, and depression to those enrolled.
Eligibility Criteria
You may qualify if:
- Must be 18 years of age or older
- Must be a United States Military Veteran
- Report current suicidal ideation
- Enrolled in outpatient substance abuse treatment within the past month
- Must live within 75 miles of treatment site at time of recruitment
You may not qualify if:
- Inability to give informed, voluntary, written consent
- Inability to speak and understand English
- Receipt of methadone treatment for substance use currently or within the past 6 months
- Evidence of active, severe psychotic symptoms
- Women who are currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- U.S. Army Medical Research and Development Commandcollaborator
- United States Department of Defensecollaborator
- US Department of Veterans Affairscollaborator
Study Sites (3)
Colorado Springs, Colorado Community-Based Outpatient Clinic
Colorado Springs, Colorado, 80907, United States
VA Eastern Colorado Health Care System
Denver, Colorado, 80220, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 12, 2015
Study Start
July 1, 2015
Primary Completion
June 12, 2020
Study Completion
June 12, 2020
Last Updated
September 23, 2022
Record last verified: 2022-09