Treatment of Depression After Coronary Bypass Surgery

The Washington University

Status: Completed

Conditions: Depression; Coronary Disease

Treatments: Behavioral: Supportive Stress Management; Behavioral: Cognitive behavior therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00042198

R01MH060735 (U.S. NIH Grant/Contract)

DSIR AT-AS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 123 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive behavior therapy

2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supportive Stress Management

3

No Intervention group

Description:

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.