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Enhancing Recovery After Cardiac Surgery

Enhancing Recovery After Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522717
Enrollment
808
Registered
2007-08-30
Start date
2005-07-31
Completion date
2010-05-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Depression

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT)

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

BEHAVIORALUsual Care

Subjects receive Usual Care for 8 weeks followed by CBT

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Depression symptoms (Beck Depression Inventory)at baseline and after 8 weeks (at the completion of the intervention)
Sleep disturbancesat baseline and after 8 weeks (at the completion of the intervention)
Presence of clinical depressionat baseline and after 8 weeks (at the completion of the intervention)
Painat baseline and after 8 weeks (at the completion of the intervention)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026