Enhancing Recovery After Cardiac Surgery

Depression Clinical Trial

Official title:

Enhancing Recovery After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522717
• Other study ID #: 5R01NR009228-02
• Secondary ID: R01NR009228
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: November 30, 2015
• Start date: July 2005
• Est. completion date: May 2010

Study information

• Verified date: November 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Depression
• Myocardial Ischemia

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)
Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
• Usual Care
Subjects receive Usual Care for 8 weeks followed by CBT

Locations

Country	Name	City	State
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles	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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of proinflammatory cytokines (IL-1 and IL-6)		at baseline and after 8 weeks (at the completion of the intervention)	No
Primary	The soluble receptor for IL-6 (sIL-6)		at baseline and after 8 weeks (at the completion of the intervention)	No
Primary	Inflammatory markers c-reactive protein (CRP and sICAM-1)		at baseline and after 8 weeks (at the completion of the intervention)	No
Secondary	Depression symptoms (Beck Depression Inventory)		at baseline and after 8 weeks (at the completion of the intervention)	No
Secondary	Presence of clinical depression		at baseline and after 8 weeks (at the completion of the intervention)	No
Secondary	Pain		at baseline and after 8 weeks (at the completion of the intervention)	No
Secondary	Sleep disturbances		at baseline and after 8 weeks (at the completion of the intervention)	No