Washington University School of Medicine
St Louis, Missouri, 63108, United States
NCT Number: NCT00042198
This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.
Looking for future studies?
Notify Me21 year and older
All sexes
Interventional
Not applicable
St Louis, Missouri, 63108, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Up to 12 weekly, individual, hour-long sessions
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
Time frame: 12 weeks post-randomization
The HAM-D-17 is an observer-rated measure of the severity of depression.
Time frame: 12 weeks post-randomization
The BDI is a self-report measure of the severity of depression.
Time frame: 12 weeks post-randomization
The BAI is a self-report measure of the severity of anxiety symptoms.
Time frame: 12 weeks post-randomization
The BHS is a self-report measure of hopelessness.
Time frame: 12 weeks post-randomization
The PSS is a self-report measure of perceived stress
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.
Washington University School of Medicine
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00005533
Behavior, Behavioral Symptoms
View Trial DetailsNCT00241761
Behavior, Behavioral Symptoms
View Trial DetailsNCT00037284
Behavior, Behavioral Symptoms
View Trial DetailsNCT00005498
Behavior, Behavioral Symptoms
View Trial Details