Clinical trial NCT02439762: Intervening to Reduce Suicide Risk in Veterans With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicidal Ideation
Substance-Related Disorders
Keywords: Veterans
Cognitive Behavioral Therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: United States Department of Defense
name: US Department of Veterans Affairs
First posted: 2015-05-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in frequency and intensity of suicidal thoughts and suicide attempts
timeFrame: Change over study time period [Baseline, 1-, 3-, 6-, 12-, 18-, and 24-months]
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado Springs, Colorado Community-Based Outpatient Clinic
state: Colorado
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
References: