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Enhancing Recovery After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522717
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Belinda Chen, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Depression Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Usual Care

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Enhancing Recovery After Cardiac Surgery
Study Start Date : July 2005
Primary Completion Date : May 2010
Study Completion Date : May 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Levels of proinflammatory cytokines (IL-1 and IL-6) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]
  2. The soluble receptor for IL-6 (sIL-6) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]
  3. Inflammatory markers c-reactive protein (CRP and sICAM-1) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]

Secondary Outcome Measures :
  1. Depression symptoms (Beck Depression Inventory) [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]
  2. Presence of clinical depression [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]
  3. Pain [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]
  4. Sleep disturbances [ Time Frame: at baseline and after 8 weeks (at the completion of the intervention) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
R01NR009228 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

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