Enhancing Recovery After Cardiac Surgery

NCT ID: NCT00522717

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

808 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

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

2

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Subjects receive Usual Care for 8 weeks followed by CBT

Interventions

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Cognitive Behavioral Therapy (CBT)

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

Intervention Type BEHAVIORAL

Usual Care

Subjects receive Usual Care for 8 weeks followed by CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Belinda Chen

Project Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynn Doering, RN, DNSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Center - Sunset

Los Angeles, California, United States

Site Status

Department of Veterans Affairs-Greater Los Angeles Healthcare System, West Los Angeles

Los Angeles, California, United States

Site Status

University of California, Los Angeles School of Nursing

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24979578 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24763358 (View on PubMed)

Other Identifiers

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R01NR009228

Identifier Type: NIH

Identifier Source: secondary_id

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5R01NR009228-02

Identifier Type: NIH

Identifier Source: org_study_id

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