Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

NCT ID: NCT02439762

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-06-12

Brief Summary

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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

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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.

Conditions

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Suicide Suicidal Ideation Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

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)

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.

Group Type ACTIVE_COMPARATOR

Supportive Psycho-education (SPC)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Mark A. Ilgen

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Colorado Springs, Colorado Community-Based Outpatient Clinic

Colorado Springs, Colorado, United States

Site Status

VA Eastern Colorado Health Care System

Denver, Colorado, United States

Site Status

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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Log Number 11224006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH 14-1-0005

Identifier Type: -

Identifier Source: org_study_id

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