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Enhancing Recovery After Cardiac Surgery

Primary Purpose

Coronary Artery Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Usual Care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Long Beach Memorial Medical Center
  • Cedars-Sinai Medical Center
  • Kaiser Permanente Medical Center - Sunset
  • Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles
  • University of California, Los Angeles School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Levels of proinflammatory cytokines (IL-1 and IL-6)
The soluble receptor for IL-6 (sIL-6)
Inflammatory markers c-reactive protein (CRP and sICAM-1)

Secondary Outcome Measures

Depression symptoms (Beck Depression Inventory)
Presence of clinical depression
Pain
Sleep disturbances

Full Information

First Posted
August 29, 2007
Last Updated
November 30, 2015
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00522717
Brief Title
Enhancing Recovery After Cardiac Surgery
Official Title
Enhancing Recovery After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Depression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
808 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Subjects receive Usual Care for 8 weeks followed by CBT
Primary Outcome Measure Information:
Title
Levels of proinflammatory cytokines (IL-1 and IL-6)
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)
Title
The soluble receptor for IL-6 (sIL-6)
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)
Title
Inflammatory markers c-reactive protein (CRP and sICAM-1)
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)
Secondary Outcome Measure Information:
Title
Depression symptoms (Beck Depression Inventory)
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)
Title
Presence of clinical depression
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)
Title
Pain
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)
Title
Sleep disturbances
Time Frame
at baseline and after 8 weeks (at the completion of the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Doering, RN, DNSc
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente Medical Center - Sunset
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California, Los Angeles School of Nursing
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24979578
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.
Results Reference
derived
PubMed Identifier
24763358
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.
Results Reference
derived

Learn more about this trial

Enhancing Recovery After Cardiac Surgery

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