Combined Illness Management and Psychotherapy in Treating Depressed Elders (COPE)
This study is currently recruiting participants.
Verified February 2013 by National Institute of Mental Health (NIMH)
Sponsor:
Information provided by (Responsible Party):
Carolyn Turvey, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT01337726
First received: March 24, 2011
Last updated: February 11, 2013
Last verified: February 2013
| Tracking Information | |||||
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| First Received Date ICMJE | March 24, 2011 | ||||
| Last Updated Date | February 11, 2013 | ||||
| Start Date ICMJE | February 2011 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction in depressive symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ] Change from Baseline in depressive symtoms at 10 weeks |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01337726 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Improvement in quality of life/functioning [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ] Change from Baseline in quality of life/functioning at 10 weeks |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combined Illness Management and Psychotherapy in Treating Depressed Elders | ||||
| Official Title ICMJE | Combined Illness Management and Psychotherapy in Treating Depressed Elders | ||||
| Brief Summary | The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| 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 | 216 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01337726 | ||||
| Other Study ID Numbers ICMJE | R01MH086482 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Carolyn Turvey, National Institute of Mental Health (NIMH) | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2013 | ||||
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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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