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Treatment of Depression After Coronary Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00042198
First received: July 24, 2002
Last updated: February 12, 2008
Last verified: February 2008
History of Changes
  Purpose

This 12-week study will test the efficacy of cognitive behavioral therapy and stress management therapy as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.


Condition Intervention
Depression
Coronary Disease
 Behavioral: Cognitive behavior therapy
Behavioral: Supportive Stress Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression After Coronary Bypass Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Enrollment: 123
Study Start Date: January 2002
Study Completion Date: August 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive Behavior Therapy
 Behavioral: Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
Active Comparator: 2
Supportive Stress Management
 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

Detailed Description:

Depression is a very common problem for people who have had CABG surgery. It is associated with concentration and memory problems, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Both CBT and SM therapy have been shown to be effective in the treatment of depression in otherwise healthy individuals. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery.

Participants are screened for depression within 1 year after surgery. Those who have depression return for additional testing 1 week later. Patients are then randomized to receive CBT, SM, or usual care (with no restriction on nonstudy antidepressants) for 12 weeks. Patients are monitored for worsening depression and are referred for additional care if needed. Depression outcomes, which include daily activities, concentration and memory, and quality of life, are assessed 12 weeks after randomization and 6 months after surgery (2 months after termination of CBT or SM).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042198

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kenneth E Freedland, Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Volunteer for Health--Washington University's research volunteer program  This link exits the ClinicalTrials.gov site

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kenneth E. Freedland, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00042198     History of Changes
Other Study ID Numbers: R01 MH60735, DSIR AT-AS
Study First Received: July 24, 2002
Last Updated: February 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive therapy
Relaxation techniques

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Depression
Depressive Disorder
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013