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Clinical Trials/NCT02439762
NCT02439762
Completed
Not Applicable

Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

University of Michigan3 sites in 1 country300 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide
Sponsor
University of Michigan
Enrollment
300
Locations
3
Primary Endpoint
Change in frequency and intensity of suicidal thoughts and suicide attempts
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
June 12, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark A. Ilgen

Associate Professor of Psychiatry

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

Study Sites (3)

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