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Completed

NCT Number: NCT02439762

Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Springs, Colorado Community-Based Outpatient Clinic, Colorado Springs, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Supportive Psycho-education (SPC)

Behavioral

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.

Primary outcomes

  1. Change in frequency and intensity of suicidal thoughts and suicide attempts

    Time frame: Change 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • U.S. Army Medical Research and Development Command
  • US Department of Veterans Affairs
  • United States Department of Defense

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 12, 2015
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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