Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

Substance-Related Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439762
• Other study ID #: W81XWH 14-1-0005
• Secondary ID: Log Number 11224
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 12, 2020

Study information

• Verified date: September 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance-Related Disorders
• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• Cognitive 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.
• Supportive 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Colorado Springs, Colorado Community-Based Outpatient Clinic	Colorado Springs	Colorado
United States	VA Eastern Colorado Health Care System	Denver	Colorado

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]