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Sponsors and Collaborators: |
Duke University University of Connecticut Health Center The University of North Carolina, Chapel Hill |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00589641 |
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.
Condition | Intervention | Phase |
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Suicide, Attempted Suicide, Ideation Depression Substance Abuse |
Behavioral: CBT-RP (relapse prevention) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Relapse Prevention for Suicidal Dually Diagnosed Youths |
Estimated Enrollment: | 12 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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:
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).
Ages Eligible for Study: | 13 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David B Goldston, Ph.D. | (919)416-2423 | david.goldston@duke.edu |
Contact: Karen Wells, Ph.D. | (919)416-2435 | wells020@mc.duke.edu |
United States, North Carolina | |
Duke Child and Family Study Center | Recruiting |
Durham, North Carolina, United States, 27705 | |
Principal Investigator: David B Goldston, Ph.D | |
Sub-Investigator: Karen Wells, Ph.D. | |
Sub-Investigator: John Curry, Ph.D. |
Principal Investigator: | David B Goldston, Ph.D. | Duke University School of Medicine |
Responsible Party: | Duke University School of Medicine ( David Goldston ) |
Study ID Numbers: | 303-7105, R34MH67904 |
Study First Received: | December 31, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00589641 |
Health Authority: | United States: Institutional Review Board |
adolescents suicidal ideation and behavior depression substance abuse |
Suicide, Attempted Depression Mental Disorders Mood Disorders Substance-Related Disorders |
Disorders of Environmental Origin Suicide Depressive Disorder Self-Injurious Behavior Behavioral Symptoms |