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

July 9, 2014 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. To develop and refine a cognitive behavioral relapse prevention treatment manual for suicidal adolescents and young adults with comorbid depressive and substance use disorders.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Child and Family Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT-RP + Enhanced TAU
CBT-RP augmenting relapse prevention intervention, in addition to enhanced treatment as usual, monthly check-ins, and monitoring
Behavioral: CBT-RP (relapse prevention) + Enhanced TAU
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.
Active Comparator: Enhanced TAU (Treatment as Usual)
Treatment as usual in the community, monthly monitoring regarding service use and needs, monitoring
Behavioral: Enhanced TAU Alone
Treatment as usual in the community, monthly check-ins regarding treatment use or needs, and monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
suicide ideation and behavior
Time Frame: pre-treatment, 10 weeks, end of treatment, 3-month follow-up
pre-treatment, 10 weeks, end of treatment, 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
depression severity, alcohol/cannabis abuse impairment
Time Frame: pre-treatment, 10 weeks, end of treatment, 3 month follow-up
pre-treatment, 10 weeks, end of treatment, 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of North Carolina, Chapel Hill
University of North Carolina, Greensboro
UConn Health

Investigators

  • Principal Investigator: David B Goldston, Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00006806
  • R34MH067904 (U.S. NIH Grant/Contract)
  • 303-7105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on CBT-RP (relapse prevention) + Enhanced TAU

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe