Overview

This trial is active, not recruiting.

Conditions coronary artery disease, depression
Treatments cognitive behavioral therapy (cbt), usual care
Phase phase 2
Sponsor University of California, Los Angeles
Collaborator National Institute of Nursing Research (NINR)
Start date July 2005
End date May 2010
Trial size 114 participants
Trial identifier NCT00522717, 5R01NR009228-02, R01NR009228

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose diagnostic
Arm
(Experimental)
cognitive behavioral therapy (cbt)
Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
(Active Comparator)
usual care
Subjects receive Usual Care for 8 weeks followed by CBT

Primary Outcomes

Measure
Levels of proinflammatory cytokines (IL-1 and IL-6
time frame: 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)
Inflammatory markers CRP and sICAM-1
time frame: at baseline and after 8 weeks (at the completion of the intervention)

Secondary Outcomes

Measure
Depression symptoms (Beck Depression Inventory)
time frame: at baseline and after 8 weeks (at the completion of the intervention)
Presence of clinical depression (Structured Interview for DSM-1V)
time frame: 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)
Sleep disturbances
time frame: at baseline and after 8 weeks (at the completion of the intervention)

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Official title Enhancing Recovery After Cardiac Surgery
Principal investigator Lynn Doering, RN, DNSc
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.