Treatment of Depression After Coronary Bypass Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00042198|
Recruitment Status : Completed
First Posted : July 26, 2002
Last Update Posted : July 2, 2013
|Condition or disease||Intervention/treatment|
|Depression Coronary Disease||Behavioral: Cognitive behavior therapy Behavioral: Supportive Stress Management|
Depression is a very common problem for people who have had CABG surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Cognitive behavior therapy (CBT) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (SSM) interventions have also been shown to improve depressive symptoms. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery.
Participants will be screened for depression within 1 year after CABG surgery. Those who have depression will return for additional testing 1 week later. Eligible participants will be randomized to receive CBT, SSM, or usual care (UC), with no restrictions on nonstudy antidepressants, for 12 weeks. Patients will be monitored for worsening depression referred for additional care if needed. Depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of CBT or SSM).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Depression After Coronary Bypass Surgery|
|Study Start Date :||December 2001|
|Primary Completion Date :||December 2005|
|Study Completion Date :||August 2006|
Cognitive Behavior Therapy. The treatment modality was individual, face-to-face therapy with an experienced cognitive therapist. Treatment consisted of up to 12 weekly, hour-long sessions.
Behavioral: Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
Active Comparator: 2
Supportive Stress Management. The treatment modality was individual, face-to-face therapy with an experienced psychotherapist. Treatment consisted of up to 12 weekly, hour-long sessions.
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
No Intervention: 3
Usual Care, minimally enhanced. Participants in all three arms were given information about depression. There were no restrictions in any of the arms on usual care for depression, heart disease, or any other conditions, except that concurrent participation in nonstudy psychotherapy was not allowed. Participants were allowed to continue or start on nonstudy antidepressants during the study, as prescribed by the participant's personal physician.
- Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: 12 weeks post-randomization ]The HAM-D-17 is an observer-rated measure of the severity of depression.
- Beck Depression Inventory [ Time Frame: 12 weeks post-randomization ]The BDI is a self-report measure of the severity of depression.
- Beck Anxiety Inventory [ Time Frame: 12 weeks post-randomization ]The BAI is a self-report measure of the severity of anxiety symptoms.
- Beck Hopelessness Scale [ Time Frame: 12 weeks post-randomization ]The BHS is a self-report measure of hopelessness.
- Perceived Stress Scale [ Time Frame: 12 weeks post-randomization ]The PSS is a self-report measure of perceived stress
- SF-36 [ Time Frame: 12 weeks post-randomization ]The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042198
|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|