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Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02439762
Enrollment
300
Registered
2015-05-12
Start date
2015-07-31
Completion date
2020-06-12
Last updated
2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-Related Disorders, Suicidal Ideation, Suicide

Keywords

Veterans, Cognitive Behavioral Therapy

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.

Detailed description

The project is a multi-site randomized controlled trial of the CBT intervention versus the SPC condition for 300 suicidal Veterans seen in Veterans Health Administration (VHA) intensive outpatient substance treatment programs (SUD IOP). Participants will be screened for current suicidal ideation and other conditions by completing a self-report survey questionnaire. Eligible participants will complete a baseline assessment which will include a self-report survey questionnaire, a research staff administered interview, and a voluntary urine drug screen. Participants will be randomized to either a Cognitive Behavior Therapy (CBT) or Supportive Psycho-education Control (SPC) condition. Both conditions will involve receipt of 8 one-on-one sessions lasting approximately one hour over a period of approximately 3-4 weeks in addition to their standard SUD IOP treatment of care they may be receiving at the VAMC. The intervention is designed to augment their current treatment, not to take the place of current treatment. Participants will be re-assessed immediately after receiving the study interventions (at 1-month) and then again at 3-, 6- 12-, 18-, and 24-month post-intervention follow-ups by completing a series of self-report surveys, researcher administered interviews, and a voluntary urine drug screen. To ensure adequate monitoring of suicidal ideation, additional telephone follow-up assessments will occur 2-, 4-, and 5-months post-intervention.

Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT)

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.

BEHAVIORALSupportive Psycho-education (SPC)

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.

Sponsors

U.S. Army Medical Research and Development Command
CollaboratorFED
United States Department of Defense
CollaboratorFED
US Department of Veterans Affairs
CollaboratorFED
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in frequency and intensity of suicidal thoughts and suicide attemptsChange over study time period [Baseline, 1-, 3-, 6-, 12-, 18-, and 24-months]This will be measured using the Columbia Suicide Severity Rating Scale (CSS-RS) and a modified version of the Time Line Follow-Back (TLFB).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026