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| Tracking Information | |||||
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| First Received Date ICMJE | December 2, 2003 | ||||
| Last Updated Date | September 22, 2008 | ||||
| Start Date ICMJE | March 2003 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) [ Time Frame: Measured continuously through month 32 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Time to Depression Symptom Rating of greater or equal to 4 [ Time Frame: Measured at Month 32 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00073671 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of depression-free days [ Time Frame: Measured continuously through Month 32 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Number of depression-free days [ Time Frame: Measured at Month 32 ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of Depression in At-Risk Adolescents | ||||
| Official Title ICMJE | Prevention of Depression in At-Risk Adolescents | ||||
| Brief Summary | This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression. |
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| Detailed Description | Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings. Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake. |
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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 | ||||
| Enrollment ICMJE | 316 | ||||
| Estimated Completion Date | January 2009 | ||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00073671 | ||||
| Responsible Party | Judy Garber, Vanderbilt University | ||||
| Study ID Numbers ICMJE | R01 MH64735, 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 | September 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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