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Developing an Intervention to Address Suicide Risk During Substance Use Disorder

Primary Purpose

Suicide, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation for substance abuse
CBT for suicide in Substance abuse
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Suicide focused on measuring Cognitive Behavioral Therapy

Eligibility Criteria

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

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

Sites / Locations

  • Community Programs, INC.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT for suicide

Enhanced care control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Level of Suicidal Ideation

Secondary Outcome Measures

Full Information

First Posted
May 20, 2010
Last Updated
May 11, 2015
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01127932
Brief Title
Developing an Intervention to Address Suicide Risk During Substance Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for suicide
Arm Type
Experimental
Arm Title
Enhanced care control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation for substance abuse
Intervention Description
This active control provides detailed information about substance use, suicide risk, and depression to those enrolled.
Intervention Type
Behavioral
Intervention Name(s)
CBT for suicide in Substance abuse
Intervention Description
The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.
Primary Outcome Measure Information:
Title
Level of Suicidal Ideation
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Community Programs, INC.
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48327
Country
United States

12. IPD Sharing Statement

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Developing an Intervention to Address Suicide Risk During Substance Use Disorder

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