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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Suicidal Ideation; Suicide
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Supportive Psycho-education (SPC)

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado Community-Based Outpatient Clinic
    • Denver, Colorado, United States, 80220
      • VA Eastern Colorado Health Care System
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: United States Department of Defense; US Department of Veterans Affairs; U.S. Army Medical Research and Development Command

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Veterans; Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Self-Injurious Behavior; Substance-Related Disorders; Suicide; Suicidal Ideation
• Other Study ID Numbers: W81XWH 14-1-0005; Log Number 11224006 (Other Grant/Funding Number: US Army Medical Research and Materiel Command)