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| Descriptive Information Fields | |||||||||
| Brief Title † | Effectiveness of Telephone Versus Face-to-Face Administered Cognitive Behavioral Therapy in Treating People With Depression | ||||||||
| Official Title † | Telephone Versus Face-to-Face Administration of CBT for Depression | ||||||||
| Brief Summary | This study will compare the effectiveness of telephone versus face-to-face administration of cognitive behavioral therapy in treating people with depression. |
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| Detailed Description | Major depressive disorder is a common and often long-lasting disorder with 12-month prevalence rates estimated to be between 6.6% and 10.3%. Although the personal and societal costs of depression are high, it is well established that depression can be effectively treated using antidepressant medication and/or forms of psychotherapy. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy or counseling over antidepressant medication. However, a variety of barriers exist to initiating and maintaining psychotherapy. Only about 20% of all patients referred for psychotherapy actually initiate treatment, and of those who do initiate treatment, nearly half drop out before completing treatment. The use of the telephone to deliver treatment services has been recommended as a way to reduce many of the barriers associated with failure to initiate and sustain treatment. When administered over the telephone, cognitive behavioral therapy (CBT), a form of psychotherapy that teaches ways to modify thoughts and behaviors that contribute to depression, may be superior to face-to-face CBT in improving treatment adherence and reducing depressive symptoms. This study will compare the effectiveness of telephone CBT (T-CBT) versus face-to-face CBT (FtF-CBT) in treating people with depression. Participation in this study will include 18 weeks of treatment and 12 months of follow-up. All participants will first undergo baseline assessments that will include a telephone interview and questionnaires about mood. Participants will then be assigned randomly to receive T-CBT or FtF-CBT. Participants in both groups will receive eighteen 45-minute sessions of their assigned treatment over 18 weeks. Sessions will occur twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. During sessions, participants will learn ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made. Treatment sessions will be identical for both groups, except one group will receive sessions over the telephone and the other in-person at a study office. All participants will repeat the baseline assessments at Weeks 4, 9, 14, and 18 of treatment and Months 3, 6, 9, and 12 of follow-up. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Attrition (e.g., number of sessions attended, dropout rate) [ Time Frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up ] [ Designated as safety issue: No ] Depression, as assessed by Patient Health Questionnaire (PHQ)-9, Hamilton Rating Scale for Depression, and Mini International Neuropsychiatric Interview (MINI) [ Time Frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Health-related quality of life (SF-36V), patient satisfaction (Satisfaction Index - Mental Health), and therapeutic alliance (Working Alliance Inventory - Short Form) [ Time Frame: Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Depression | ||||||||
| Intervention † | Behavioral: Telephone-administered cognitive behavioral therapy (T-CBT) Behavioral: Face-to-face administered cognitive behavioral therapy (FtF-CBT) |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 240 | ||||||||
| Start Date † | December 2007 | ||||||||
| Completion Date | October 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00498706 | ||||||||
| Organization ID | R01 MH059708 | ||||||||
| Secondary IDs †† | DSIR 83-ATAS | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | July 8, 2007 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||