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| Descriptive Information Fields | |||||||||
| Brief Title † | Cognitive Therapy for Treating Depression and Preventing Relapse | ||||||||
| Official Title † | Prophylactic Cognitive Therapy for Depression | ||||||||
| Brief Summary | This study will compare the effectiveness of cognitive therapy versus antidepressant medication in treating depression and preventing relapse in individuals with recurrent depression. |
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| Detailed Description | Cognitive therapy (CT) is a form of therapy that focuses on changing negative thinking patterns and developing coping skills to deal with psychological problems. It encourages individuals to think, feel, and behave in a more positive manner. Previous research has shown that CT is effective for treating a number of psychological symptoms, including anxiety, anger, and loneliness. Many studies show that CT is, in fact, more effective than antidepressant medications for treating various psychological disorders. The "self-help" mentality and coping skills that are developed during CT tend to decrease the likelihood of depression relapse. While antidepressants often cause many unpleasant side effects such as dizziness, nausea, and increased heart rate, there are no known negative side effects associated with CT. The purpose of this study is to evaluate the effectiveness of CT versus antidepressant medication for treating depression and preventing relapse in individuals with recurrent depression. This 36-month study will consist of three phases. During Months 1 through 3, participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressant medication, or placebo for 8 months. Upon completing treatment, follow-up visits will occur once every 4 months for a total of 24 months. Outcome measurements will include standardized psychological tests and questionnaires to assess the participant's level of depression. All measurements will be assessed at Week 1, Week 12, and Months 8, 12, 16, 20, and 24. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Depressive relapse [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Psychosocial functioning [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Depression | ||||||||
| Intervention † | Drug: Fluoxetine Behavioral: Cognitive therapy (CT) Drug: Placebo |
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| MEDLINE PMIDs | 10086480, 10403142, 10708817, 10937603 | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 900 | ||||||||
| Start Date † | December 1999 | ||||||||
| Completion Date | December 2012 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00183664 | ||||||||
| Organization ID | R01 MH58356 | ||||||||
| Secondary IDs †† | 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 | February 2008 | ||||||||
| First Received Date † | September 13, 2005 | ||||||||
| Last Updated Date | February 12, 2008 | ||||||||
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