Enhancing Recovery After Cardiac Surgery

Not Applicable

Completed

• Conditions: Depression; Coronary Artery Disease
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Usual Care

• Registration Number: NCT00522717
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-30
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 808

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive Behavioral Therapy (CBT)	-
2	Usual Care	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Depression symptoms (Beck Depression Inventory)	at baseline and after 8 weeks (at the completion of the intervention)
Presence of clinical depression	at baseline and after 8 weeks (at the completion of the intervention)
Pain	at baseline and after 8 weeks (at the completion of the intervention)
Sleep disturbances	at baseline and after 8 weeks (at the completion of the intervention)

Trial Locations

Locations (5)

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente Medical Center - Sunset; 🇺🇸 Los Angeles, California, United States

University of California, Los Angeles School of Nursing; 🇺🇸 Los Angeles, California, United States

Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles; 🇺🇸 Los Angeles, California, United States