Effectiveness of Emotion-Focused Cognitive Behavioral Therapy for Treating Adolescents With Emotional Disorders
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | February 29, 2008 | ||||
| Last Updated Date | April 2, 2009 | ||||
| Start Date ICMJE | July 2006 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Clinical Severity Rating (CSR) on the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions (ADIS-IV-C/P) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00628888 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Emotion-Focused Cognitive Behavioral Therapy for Treating Adolescents With Emotional Disorders | ||||
| Official Title ICMJE | Treatment of Emotional Disorders in Adolescence | ||||
| Brief Summary | This study will evaluate the effectiveness of an emotion-focused cognitive behavioral treatment program for adolescents with anxiety or unipolar depressive disorders. |
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| Detailed Description | Anxiety and depression are among the most prevalent psychiatric disorders in youth. Adolescents with anxiety or depression experience persistent emotional distress that can cause problems with school, family, and friends. In addition, anxiety and depressive disorders commonly co-exist, causing further distress for those affected. If left untreated, the difficulties associated with these disorders can persist into adulthood. Fortunately, anxiety and depression are highly treatable using a combination of medications and forms of psychotherapy, but many youth in community settings are unlikely to receive these treatments. An emotion-focused, cognitive behavioral treatment, specifically designed to meet a broad range of treatment needs of adolescents, may provide one way of translating effective treatment components to community settings. This study will evaluate the effectiveness of a transdiagnostic, emotion-focused, cognitive behavioral treatment program, called the Unified Protocol for the Treatment of Emotional Disorders in Youth (UP-Y), for adolescents with anxiety or unipolar depressive disorders. Participants in this study will be assigned to receive either immediate or delayed UP-Y program sessions. Study participation will last up to 12 months after beginning treatment. Upon initiation of treatment, parent and child participants will undergo initial assessments that will include questionnaires about anxiety, worry, depression and emotion regulation; and an interview pertaining to the adolescent's anxiety and depression. Both parent and adolescent participants will then attend up to 21 weekly treatment sessions, lasting 60 minutes each. During sessions, participants will learn skills regarding acceptance of intense emotional states, how to actively cope with emotions, and act in healthy ways during anxiety- and depression-provoking situations. Throughout the course of treatment, parent and adolescent participants will be asked to keep records about the adolescent's emotions and functioning. Participants will also be given at-home assignments to practice skills learned in treatment sessions. During and after treatment, participants will complete questionnaires about their thoughts on the treatment sessions. Participants will repeat the initial assessment either following the waitlist delayed treatment condition or 8 weeks into treatment, immediately after the last treatment session as well as at months 3 and 6 of follow-up. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Unified Treatment for Emotional Disorders in Youth (UP-Y)
All participants will receive between 8 and 21 weekly sessions of an emotion-focused cognitive behavioral treatment. These sessions will be delivered in a flexible manner, with skills such as psycho-education, motivational interviewing, emotion awareness, crisis management, parent emotion management, cognitive reappraisal/problem solving, emotion exposures, and relapse prevention. Participants will be randomly assigned to either a wait list or immediate treatment condition. All participants, regardless of assignment will be offered the intervention. Participants assigned to the wait list condition will have an initial 8 week waiting period with minimal clinical contact (clinical check in every other week) before receiving active treatment. Other Names:
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| Study Arm (s) | Experimental: 1
Participants will receive the UP-Y, either immediately or after an 8 week wait list period.
Intervention: Behavioral: Unified Treatment for Emotional Disorders in Youth (UP-Y) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00628888 | ||||
| Other Study ID Numbers ICMJE | K23 MH073946, DDTR BK-TKPD | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jill T. Ehrenreich, PhD, Assistant Professor of Psychology, University of Miami | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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