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Treatment of Depression After Coronary Bypass Surgery

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00042198
  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

MedlinePlus related topics:   Coronary Artery Bypass Surgery    Depression    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:   Treatment of Depression After Coronary Bypass Surgery

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
1: Experimental
Cognitive Behavior Therapy
Behavioral: Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
2: Active Comparator
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
3: No Intervention
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

Investigators
Principal Investigator:     Kenneth E Freedland, Ph.D.     Washington University School of Medicine    
  More Information

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

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

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

Study placed in the following topic categories:
Coronary Disease
Heart Diseases
Depression
Mental Disorders
Myocardial Ischemia
Mood Disorders
Vascular Diseases
Ischemia
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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