Treatment of Depression After Coronary Bypass Surgery

July 1, 2013 updated by: Kenneth Freedland, Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
Active Comparator: 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.
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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression (HAM-D-17)
Time Frame: 12 weeks post-randomization
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
Time Frame: 12 weeks post-randomization
The BDI is a self-report measure of the severity of depression.
12 weeks post-randomization
Beck Anxiety Inventory
Time Frame: 12 weeks post-randomization
The BAI is a self-report measure of the severity of anxiety symptoms.
12 weeks post-randomization
Beck Hopelessness Scale
Time Frame: 12 weeks post-randomization
The BHS is a self-report measure of hopelessness.
12 weeks post-randomization
Perceived Stress Scale
Time Frame: 12 weeks post-randomization
The PSS is a self-report measure of perceived stress
12 weeks post-randomization
SF-36
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.
12 weeks post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kenneth E Freedland, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

July 24, 2002

First Submitted That Met QC Criteria

July 25, 2002

First Posted (Estimate)

July 26, 2002

Study Record Updates

Last Update Posted (Estimate)

July 2, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH060735 (U.S. NIH Grant/Contract)
  • DSIR AT-AS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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