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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 23, 2008 | ||||
| Start Date ICMJE | September 2004 | ||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Depressive symptoms [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Depressive symptoms | ||||
| Change History | Complete list of historical versions of study NCT00183417 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Depression Prevention Program for Adolescents | ||||
| Official Title ICMJE | Depression Prevention Program for High-Risk Adolescents | ||||
| Brief Summary | This study will compare the effectiveness of two programs designed to prevent depression in adolescents. |
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| Detailed Description | Major depression is one of the most common psychiatric disorders in adolescents. In many cases, the condition is recurrent and can result in serious psychological impairment. A high number of depressed adolescents never receive treatment; therefore, it is crucial to develop prevention programs for this disorder that are effective and can be easily disseminated. This study will evaluate and compare the effectiveness of cognitive behavior therapy (CBT) and supportive/expressive (S/E) therapy in preventing depressive symptoms in adolescents. This study will last 2 years. Participants will be randomly assigned to receive six sessions of CBT, S/E therapy, or standard depression education over 2 years. The CBT intervention will focus on reducing negative thoughts and increasing engagement in pleasant activities. S/E therapy is designed to allow adolescents to express their negative emotions and talk about recent stressful events in a supportive environment of their peers. Surveys and psychiatric interviews will be completed by all participants and their parents at the beginning and the end of the study. The surveys and interviews will assess depressive symptoms. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 350 | ||||
| Estimated Completion Date | May 2009 | ||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00183417 | ||||
| Responsible Party | Eric Stice, PhD, University of Texas at Austin | ||||
| Study ID Numbers ICMJE | R01 MH67183, DSIR 84-CTP | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | October 2008 | ||||
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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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