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Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

Primary Purpose

Suicide, Suicidal Ideation, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Supportive Psycho-education (SPC)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Veterans, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Colorado Springs, Colorado Community-Based Outpatient Clinic
  • VA Eastern Colorado Health Care System
  • VA Ann Arbor Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy (CBT)

Supportive Psycho-education (SPC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 1, 2015
Last Updated
September 22, 2022
Sponsor
University of Michigan
Collaborators
U.S. Army Medical Research and Development Command, United States Department of Defense, US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT02439762
Brief Title
Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
U.S. Army Medical Research and Development Command, United States Department of Defense, US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation, Substance-Related Disorders
Keywords
Veterans, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Psycho-education (SPC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psycho-education (SPC)
Intervention Description
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 Outcome Measure Information:
Title
Change in frequency and intensity of suicidal thoughts and suicide attempts
Description
This will be measured using the Columbia Suicide Severity Rating Scale (CSS-RS) and a modified version of the Time Line Follow-Back (TLFB).
Time Frame
Change over study time period [Baseline, 1-, 3-, 6-, 12-, 18-, and 24-months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Colorado Springs, Colorado Community-Based Outpatient Clinic
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
VA Eastern Colorado Health Care System
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

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