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| Tracking Information | |||||
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| First Received Date ICMJE | July 24, 2002 | ||||
| Last Updated Date | February 12, 2008 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00042198 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Depression After Coronary Bypass Surgery | ||||
| Official Title ICMJE | Treatment of Depression After Coronary Bypass Surgery | ||||
| Brief Summary | This 12-week study will test the efficacy of cognitive behavioral therapy and stress management therapy as treatments for depression in people who have recently undergone coronary artery bypass graft surgery. |
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| Detailed Description | Depression is a very common problem for people who have had CABG surgery. It is associated with concentration and memory problems, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Both CBT and SM therapy have been shown to be effective in the treatment of depression in otherwise healthy individuals. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery. Participants are screened for depression within 1 year after surgery. Those who have depression return for additional testing 1 week later. Patients are then randomized to receive CBT, SM, or usual care (with no restriction on nonstudy antidepressants) for 12 weeks. Patients are monitored for worsening depression and are referred for additional care if needed. Depression outcomes, which include daily activities, concentration and memory, and quality of life, are assessed 12 weeks after randomization and 6 months after surgery (2 months after termination of CBT or SM). |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Dávila-Román VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 123 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00042198 | ||||
| Responsible Party | Kenneth E. Freedland, PhD, Washington University School of Medicine | ||||
| Study ID Numbers ICMJE | R01 MH60735, DSIR AT-AS | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
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| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
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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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