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OpenTrials
Completed

NCT Number: NCT00522717

Enhancing Recovery After Cardiac Surgery

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Disease Depression Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Memorial Medical Center, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.

Usual Care

Behavioral

Subjects receive Usual Care for 8 weeks followed by CBT

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2007
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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