Relapse Prevention for Suicidal Dually Diagnosed Youths (CBT-RP)
|ClinicalTrials.gov Identifier: NCT00589641|
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : July 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Suicide, Attempted Suicide, Ideation Depression Substance Abuse||Behavioral: CBT-RP (relapse prevention) + Enhanced TAU Behavioral: Enhanced TAU Alone||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Relapse Prevention for Suicidal Dually Diagnosed Youths|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
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
- suicide ideation and behavior [ Time Frame: pre-treatment, 10 weeks, end of treatment, 3-month follow-up ]
- depression severity, alcohol/cannabis abuse impairment [ Time Frame: pre-treatment, 10 weeks, end of treatment, 3 month follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589641
|United States, North Carolina|
|Duke Child and Family Study Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||David B Goldston, Ph.D.||Duke University|