A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
This study is currently recruiting participants.
Verified June 2012 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
Mary Beth Gibbons, Ph.D., University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01207271
First received: September 21, 2010
Last updated: June 26, 2012
Last verified: June 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 21, 2010 | ||||||||
| Last Updated Date | June 26, 2012 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Symptomatic level of depression as measured by the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline, Month 1, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01207271 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings | ||||||||
| Official Title ICMJE | A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings | ||||||||
| Brief Summary | The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic psychotherapy, with cognitive therapy for the treatment of depression in community mental health consumers. Hypothesized mediators of treatment will also be examined. |
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| Detailed Description | The goal of this study is to conduct a randomized, comparative, non-inferiority clinical trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy (supportive-expressive psychodynamic therapy) is not inferior to cognitive therapy when implemented in community mental health settings for the treatment of major depressive disorder (MDD). The specific aims are (1) to conduct a randomized non-inferiority trial to compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with MDD and (2) to assess the comparative effectiveness of supportive-expressive psychodynamic therapy and cognitive therapy on secondary measures of symptoms, patient functioning, and quality of life. Patient mediators of outcome will also be examined through an additional grant awarded to Paul Crits-Christoph, Ph.D. This grant was funded by the National Institutes of Mental Health - RO1MH092363-01. This grant is entitled:"The mechanisms of cognitive and dynamic therapy in community settings." Recruitment will occur solely through community mental health clinics in and around Philadelphia. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Major Depressive Disorder | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 230 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01207271 | ||||||||
| Other Study ID Numbers ICMJE | R01HS018440 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Mary Beth Gibbons, Ph.D., University of Pennsylvania | ||||||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pennsylvania | ||||||||
| Verification Date | June 2012 | ||||||||
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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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