Clinical trial NCT00522717: Enhancing Recovery After Cardiac Surgery
Official title: Enhancing Recovery After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Depression
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2007-08-30
Enrollment: 808
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Levels of proinflammatory cytokines (IL-1 and IL-6)
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
measure: The soluble receptor for IL-6 (sIL-6)
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
measure: Inflammatory markers c-reactive protein (CRP and sICAM-1)
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
Secondary outcomes:
measure: Depression symptoms (Beck Depression Inventory)
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
measure: Presence of clinical depression
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
measure: Pain
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
measure: Sleep disturbances
timeFrame: at baseline and after 8 weeks (at the completion of the intervention)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center - Sunset
state: California
city: Los Angeles
country: United States
facility: Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles School of Nursing
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Lynn Doering, RN, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doering LV, Chen B, McGuire A, Bodan RC, Irwin MR. Persistent depressive symptoms and pain after cardiac surgery. Psychosom Med. 2014 Jul-Aug;76(6):437-44. doi: 10.1097/PSY.0000000000000074.
citation: Hwang B, Eastwood JA, McGuire A, Chen B, Cross-Bodan R, Doering LV. Cognitive behavioral therapy in depressed cardiac surgery patients: role of ejection fraction. J Cardiovasc Nurs. 2015 Jul-Aug;30(4):319-24. doi: 10.1097/JCN.0000000000000155.