Developing an Intervention to Address Suicide Risk During Substance Use Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01127932
First received: May 20, 2010
Last updated: August 2, 2011
Last verified: June 2011
  Purpose

This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.


Condition Intervention
Suicide
Substance-Related Disorders
Behavioral: Psychoeducation for substance abuse
Behavioral: CBT for suicide in Substance abuse

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Level of Suicidal Ideation [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT for suicide Behavioral: CBT for suicide in Substance abuse
The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.
Active Comparator: Enhanced care control group
This group is designed to be an active control which provides detailed information about substance use, suicide risk, and depression without providing any CBT or other specific therapy.
Behavioral: Psychoeducation for substance abuse
This active control provides detailed information about substance use, suicide risk, and depression to those enrolled.

Detailed Description:

Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. Patients for this trial will be screened at the SUD treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be over 18 years of age
  • Report a past lifetime suicide attempt
  • Report current suicidal ideation
  • Resided in treatment for less than 4 weeks
  • In treatment for less than 6 months

Exclusion Criteria:

  • Mental incompetence (e.g. unable to provide informed consent)
  • Diagnosis of schizophrenia or currently psychotic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127932

Locations
United States, Michigan
Community Programs, INC.
Waterford, Michigan, United States, 48327
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Mark A. Ilgen, University of Michigan
ClinicalTrials.gov Identifier: NCT01127932     History of Changes
Other Study ID Numbers: 5R21DA026925-02
Study First Received: May 20, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Substance-Related Disorders
Suicide
Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 16, 2014