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Treatment of Depression After Coronary Bypass Surgery
This study has been completed.
Study NCT00042198   Information provided by National Institute of Mental Health (NIMH)
First Received: July 24, 2002   Last Updated: February 12, 2008   History of Changes

July 24, 2002
February 12, 2008
January 2002
December 2005   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00042198 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Depression After Coronary Bypass Surgery
Treatment of Depression After Coronary Bypass Surgery

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.

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).

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Depression
  • Coronary Disease
  • Behavioral: Cognitive behavior therapy
  • Behavioral: Supportive Stress Management
  • Experimental: Cognitive Behavior Therapy
  • Active Comparator: Supportive Stress Management
  • No Intervention: Usual Care
Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Dávila-Román VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
123
August 2006
December 2005   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042198
Kenneth E. Freedland, PhD, Washington University School of Medicine
R01 MH60735, DSIR AT-AS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Kenneth E Freedland, Ph.D. Washington University School of Medicine
National Institute of Mental Health (NIMH)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP