Coronary Disease, Depression
Conditions
Keywords
Cognitive therapy, Relaxation techniques
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALCognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
BEHAVIORALSupportive Stress Management
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
Sponsors
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months * Meets DSM-IV criteria for major or minor depressive episode
Exclusion criteria
* Severe cognitive impairment * Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia) * Severely debilitating or life-threatening illness other than coronary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D-17) | 12 weeks post-randomization | The HAM-D-17 is an observer-rated measure of the severity of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory | 12 weeks post-randomization | The BDI is a self-report measure of the severity of depression. |
| Beck Anxiety Inventory | 12 weeks post-randomization | The BAI is a self-report measure of the severity of anxiety symptoms. |
| Beck Hopelessness Scale | 12 weeks post-randomization | The BHS is a self-report measure of hopelessness. |
| Perceived Stress Scale | 12 weeks post-randomization | The PSS is a self-report measure of perceived stress |
| SF-36 | 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. |
Countries
United States
Outcome results
None listed