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Enhancing Recovery After Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Belinda Chen, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00522717
First received: August 29, 2007
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of depression, and depression is associated with higher risk of complications and death. Recent discoveries show that depression involves changes in certain molecules in the blood, which are also involved in progressive coronary artery disease (CAD) and its complications. This study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for depression on these biological markers among CABG patients.

Condition Intervention
Coronary Artery Disease
Depression
Behavioral: Cognitive Behavioral Therapy (CBT)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Enhancing Recovery After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Levels of proinflammatory cytokines (IL-1 and IL-6) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]
  • The soluble receptor for IL-6 (sIL-6) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]
  • Inflammatory markers c-reactive protein (CRP and sICAM-1) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression symptoms (Beck Depression Inventory) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]
  • Presence of clinical depression [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]
  • Sleep disturbances [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ] [ Designated as safety issue: No ]

Enrollment: 808
Study Start Date: July 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Cognitive Behavioral Therapy (CBT)
Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
Active Comparator: 2 Behavioral: Usual Care
Subjects receive Usual Care for 8 weeks followed by CBT

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergone CABG at one of our recruitment sites

Exclusion Criteria:

  • Less than 45 years of age
  • Have cognitive impairment or major comorbid psychiatric conditions
  • Have autoimmune disorder or malignancy
  • Currently smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522717

Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90027
Kaiser Permanente Medical Center - Sunset
Los Angeles, California, United States, 90027
Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles
Los Angeles, California, United States, 90073
University of California, Los Angeles School of Nursing
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Lynn Doering, RN, DNSc University of California, Los Angeles
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Belinda Chen, Project Director, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00522717     History of Changes
Other Study ID Numbers: 5R01NR009228-02  R01NR009228 
Study First Received: August 29, 2007
Last Updated: November 30, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016