Enhancing Recovery After Cardiac Surgery

November 30, 2015 updated by: Belinda Chen, University of California, Los Angeles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

808

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90027
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Medical Center - Sunset
      • Los Angeles, California, United States, 90073
        • Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression symptoms (Beck Depression Inventory)
Time Frame: at baseline and after 8 weeks (at the completion of the intervention)
at baseline and after 8 weeks (at the completion of the intervention)
Presence of clinical depression
Time Frame: at baseline and after 8 weeks (at the completion of the intervention)
at baseline and after 8 weeks (at the completion of the intervention)
Pain
Time Frame: at baseline and after 8 weeks (at the completion of the intervention)
at baseline and after 8 weeks (at the completion of the intervention)
Sleep disturbances
Time Frame: at baseline and after 8 weeks (at the completion of the intervention)
at baseline and after 8 weeks (at the completion of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Lynn Doering, RN, DNSc, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01NR009228-02 (U.S. NIH Grant/Contract)
  • R01NR009228 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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