Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

Not Applicable

Completed

• Conditions: Suicidal Ideation; Suicide; Substance-Related Disorders
• Interventions: Behavioral: Supportive Psycho-education (SPC); Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT02439762
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Study Start: 2015-07
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Psycho-education (SPC)	Supportive Psycho-education (SPC)	The 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.
Cognitive Behavioral Therapy (CBT)	Cognitive Behavioral Therapy (CBT)	The 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.

Primary Outcome Measures

Name	Time	Method
Change in frequency and intensity of suicidal thoughts and suicide attempts	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).

Trial Locations

Locations (3)

VA Eastern Colorado Health Care System; 🇺🇸 Denver, Colorado, United States

Colorado Springs, Colorado Community-Based Outpatient Clinic; 🇺🇸 Colorado Springs, Colorado, United States

VA Ann Arbor Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States