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Relapse Prevention for Suicidal Dually Diagnosed Youths (CBT-RP)

Primary Purpose

Suicide, Attempted, Suicide, Ideation, Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT-RP (relapse prevention) + Enhanced TAU
Enhanced TAU Alone
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring adolescents, suicidal ideation and behavior, depression, substance abuse

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Teenagers 13-19 living with parents, or foster parents, at least one of whom is English speaking and willing to participate Participation in ongoing treatment in the community (or willing to accept a referral for treatment as usually delivered in the community) Marijuana or alcohol use or dependence disorder Depressive disorder (major depression, dysthymia, depressive disorder NOS) High suicide risk as reflected in: (a) recent suicidal behaviors (suicide attempts, aborted attempts, interrupted attempts, or suicide plans) in last 4 weeks OR (b)lifetime history of suicidal behaviors together with current clinically significant suicidal ideation (measured on a self-report questionnaire) Exclusion Criteria: Substance Dependence Disorder other than alcohol or cannabis or nicotine SUD severity such that higher (more intensive) level of treatment (e.g., residential, hospitalization) is needed Psychiatric difficulty other than substance abuse, suicidality, or depression that needs to be the primary focus of treatment (e.g., severe eating disorder or psychosis) Evidence of mental retardation or poor receptive vocabulary as assessed with Peabody Picture Vocabulary Test

Sites / Locations

  • Duke Child and Family Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-RP + Enhanced TAU

Enhanced TAU (Treatment as Usual)

Arm Description

CBT-RP augmenting relapse prevention intervention, in addition to enhanced treatment as usual, monthly check-ins, and monitoring

Treatment as usual in the community, monthly monitoring regarding service use and needs, monitoring

Outcomes

Primary Outcome Measures

suicide ideation and behavior

Secondary Outcome Measures

depression severity, alcohol/cannabis abuse impairment

Full Information

First Posted
December 31, 2007
Last Updated
July 9, 2014
Sponsor
Duke University
Collaborators
UConn Health, University of North Carolina, Chapel Hill, University of North Carolina, Greensboro
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1. Study Identification

Unique Protocol Identification Number
NCT00589641
Brief Title
Relapse Prevention for Suicidal Dually Diagnosed Youths
Acronym
CBT-RP
Official Title
Relapse Prevention for Suicidal Dually Diagnosed Youths
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
UConn Health, University of North Carolina, Chapel Hill, University of North Carolina, Greensboro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to develop, refine, and pilot test an augmenting cognitive behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and alcohol/substance abusing adolescents. No hypotheses are being tested, but it is expected that CBT-RP in addition to treatment as usual will result in improved outcomes relative to treatment as usual alone.
Detailed Description
Suicide attempts are not only associated with increased likelihood of eventual death by suicide (Lonnqvist & Ostano, 1991), increased risk of repeat suicidal behavior (Goldston et al., 1999; Leon et al., 1989), and risk of physical injury, but suicidality is also one of the primary reasons for psychiatric emergencies and psychiatric hospitalizations (Peterson et al., 1996). Suicide attempters, particularly repeat attempters, often have histories of both depression and substance abuse problems. Cognitive behavioral interventions have been shown to have promise in the treatment of depression (Brent et al., 1997), suicidality (Henriques, Beck, & Brown, 2002), and substance use disorders in youths (Dennis et al., in press; Kaminer et al., 2002). Relapse prevention approaches have been shown to have utility with substance abusing adults (Witkiewitz & Marlatt, 2004), and conceptually are well suited for the prevention of both suicidal behavior and substance use among young people. The purpose of the research outlined in this application is therefore to develop, refine, and test a cognitive behavioral relapse prevention intervention (CBT-RP) for dually diagnosed suicidal adolescents and young adults. The specific aims of this research are as follows: To develop and refine a cognitive behavioral relapse prevention treatment manual for suicidal adolescents and young adults with comorbid depressive and substance use disorders. To develop and pilot test procedures for training therapists to conduct CBT-RP. Methods for assessing therapist competence and adherence to the protocols, and certification standards will be developed and refined. To assess the feasibility of CBT-RP via monitoring of rates of recruitment and retention of subjects, monitoring of therapist adherence and deviation from the protocols, and monitoring of adverse events. To assess the feasibility of the assessment methods and outcome measures to be used in this study as reflected in burden in completing assessments over the course of treatment. To estimate the degree of change and variability of response to CBT-RP relative to no CBT-RP as an add-on treatment to Treatment as Usual (TAU) in the community on the primary outcomes of suicidal ideation, depressive symptoms, and substance use problem severity. To assess the acceptability of CBT-RP relative to no CBT-RP as an add-on treatment to TAU in the community as assessed qualitatively via exit interviews and quantitatively via ratings of patient satisfaction There are four phases to this treatment development study: (1) initial manual and protocol development (not requiring human subject involvement); (2) piloting (and revision) of the manual by the investigators; (3) training and supervision of new therapists using the new intervention; and, (4) the pilot randomized controlled trial. We have completed the first phase of this study. Currently, we are involved in completing pilot testing and initiating training of new therapists with the protocol (n=12). A subsequent pilot randomized controlled trial will be used to examine feasibility and preliminary evidence of effects (and variability of effects) of CBT-RP as an augmenting intervention (n=36).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicide, Ideation, Depression, Substance Abuse
Keywords
adolescents, suicidal ideation and behavior, depression, substance abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-RP + Enhanced TAU
Arm Type
Experimental
Arm Description
CBT-RP augmenting relapse prevention intervention, in addition to enhanced treatment as usual, monthly check-ins, and monitoring
Arm Title
Enhanced TAU (Treatment as Usual)
Arm Type
Active Comparator
Arm Description
Treatment as usual in the community, monthly monitoring regarding service use and needs, monitoring
Intervention Type
Behavioral
Intervention Name(s)
CBT-RP (relapse prevention) + Enhanced TAU
Intervention Description
CBT-RP is an 20-week augmenting intervention. CBT-RP is based primarily on Alan Marlatt's cognitive behavioral relapse prevention model for substance abuse, but also includes motivational interviewing and mindfulness meditation approaches. Sessions are twice a week in first week, then weekly thereafter, with tapering to biweekly in the last 8 weeks depending on improvement. Participants also receive treatment as usual, and monthly check-ins regarding treatment use.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced TAU Alone
Intervention Description
Treatment as usual in the community, monthly check-ins regarding treatment use or needs, and monitoring
Primary Outcome Measure Information:
Title
suicide ideation and behavior
Time Frame
pre-treatment, 10 weeks, end of treatment, 3-month follow-up
Secondary Outcome Measure Information:
Title
depression severity, alcohol/cannabis abuse impairment
Time Frame
pre-treatment, 10 weeks, end of treatment, 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Teenagers 13-19 living with parents, or foster parents, at least one of whom is English speaking and willing to participate Participation in ongoing treatment in the community (or willing to accept a referral for treatment as usually delivered in the community) Marijuana or alcohol use or dependence disorder Depressive disorder (major depression, dysthymia, depressive disorder NOS) High suicide risk as reflected in: (a) recent suicidal behaviors (suicide attempts, aborted attempts, interrupted attempts, or suicide plans) in last 4 weeks OR (b)lifetime history of suicidal behaviors together with current clinically significant suicidal ideation (measured on a self-report questionnaire) Exclusion Criteria: Substance Dependence Disorder other than alcohol or cannabis or nicotine SUD severity such that higher (more intensive) level of treatment (e.g., residential, hospitalization) is needed Psychiatric difficulty other than substance abuse, suicidality, or depression that needs to be the primary focus of treatment (e.g., severe eating disorder or psychosis) Evidence of mental retardation or poor receptive vocabulary as assessed with Peabody Picture Vocabulary Test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Goldston, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Child and Family Study Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Relapse Prevention for Suicidal Dually Diagnosed Youths

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