Treatment of Depression After Coronary Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2006-08-31

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.

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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).

Conditions

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Depression Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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.

Group Type EXPERIMENTAL

Cognitive behavior therapy

Intervention Type BEHAVIORAL

Up to 12 weekly, individual, hour-long sessions

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.

Group Type ACTIVE_COMPARATOR

Supportive Stress Management

Intervention Type BEHAVIORAL

Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive behavior therapy

Up to 12 weekly, individual, hour-long sessions

Intervention Type 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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No