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| Descriptive Information Fields | |||||
| Brief Title † | Cognitive Therapy for Recurrent Depression | ||||
| Official Title † | Prophylactic Cognitive Therapy for Depression. | ||||
| Brief Summary | This study will determine the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression. |
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| Detailed Description | Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression. This study will last approximately 36 months and will comprise three phases. For the first 12 weeks, all participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants will have follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires will be used to assess depressive symptoms of participants at study start and at the end of each study phase. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Depressive relapse [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Psychosocial functioning [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ] | ||||
| Condition † | Depression | ||||
| Intervention † | Behavioral: Continuation phase cognitive therapy Drug: Continuation phase fluoxetine Other: Continuation phase pill placebo Behavioral: Initial phase cognitive therapy |
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| MEDLINE PMIDs | 15816788, 11296099, 11074876 | ||||
| Links | Psychosocial Research and Depression Clinic ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 785 | ||||
| Start Date † | December 1999 | ||||
| Completion Date | May 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00118404 | ||||
| Organization ID | R01 MH58397 | ||||
| Secondary IDs †† | R01 MH69619, DSIR 83-ATP | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | July 6, 2005 | ||||
| Last Updated Date | March 4, 2008 | ||||