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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00042198 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression Coronary Disease |
Behavioral: Cognitive behavior therapy Behavioral: Supportive Stress Management |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Treatment of Depression After Coronary Bypass Surgery |
| Enrollment: | 123 |
| Study Start Date: | January 2002 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Cognitive Behavior Therapy
|
Behavioral: Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
|
|
2: Active Comparator
Supportive Stress Management
|
Behavioral: Supportive Stress Management
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
|
|
3: No Intervention
Usual Care
|
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).
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63108 | |
| Principal Investigator: | Kenneth E Freedland, Ph.D. | Washington University School of Medicine |
More Information
| Responsible Party: | Washington University School of Medicine ( Kenneth E. Freedland, PhD ) |
| Study ID Numbers: | R01 MH60735, DSIR AT-AS |
| Study First Received: | July 24, 2002 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00042198 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cognitive therapy Relaxation techniques |
|
Arterial Occlusive Diseases Depression Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis |
Depressive Disorder Behavioral Symptoms Coronary Disease Mental Disorders Mood Disorders Coronary Artery Disease |
|
Arterial Occlusive Diseases Depression Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Depressive Disorder |
Behavioral Symptoms Coronary Disease Mental Disorders Mood Disorders Cardiovascular Diseases Coronary Artery Disease |
