Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT02439762

Collaborator

U.S. Army Medical Research and Development Command (U.S. Fed), United States Department of Defense (U.S. Fed), US Department of Veterans Affairs (U.S. Fed)

300

Enrollment

Locations

Arms

Actual Duration (Months)

100

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide Suicidal Ideation Substance-Related Disorders	Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Supportive Psycho-education (SPC)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jun 12, 2020

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado Springs, Colorado Community-Based Outpatient Clinic	Colorado Springs	Colorado	United States	80907
2	VA Eastern Colorado Health Care System	Denver	Colorado	United States	80220
3	VA Ann Arbor Healthcare System	Ann Arbor	Michigan	United States	48105