Treatment of Depression After Coronary Bypass Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Treatment of Depression After Coronary Bypass Surgery

Conditions
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Depression, Coronary Disease

Intervention / Treatment
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* Behavioral: Cognitive behavior therapy
* Behavioral: Supportive Stress Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Up to 12 weekly, individual, hour-long sessions<br>|
| Active Comparator: 2<br>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<br>* Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors<br>|
| No Intervention: 3<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D-17) | The HAM-D-17 is an observer-rated measure of the severity of depression. | 12 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory | The BDI is a self-report measure of the severity of depression. | 12 weeks post-randomization | 
| Beck Anxiety Inventory | The BAI is a self-report measure of the severity of anxiety symptoms. | 12 weeks post-randomization | 
| Beck Hopelessness Scale | The BHS is a self-report measure of hopelessness. | 12 weeks post-randomization | 
| Perceived Stress Scale | The PSS is a self-report measure of perceived stress | 12 weeks post-randomization | 
| SF-36 | The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported. | 12 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive therapy, Relaxation techniques