NCT00522717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
808

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

4.8 years

First QC Date

August 29, 2007

Last Update Submit

November 30, 2015

Conditions

Coronary Artery DiseaseDepression

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Depression symptoms (Beck Depression Inventory)

    at baseline and after 8 weeks (at the completion of the intervention)

  • Presence of clinical depression

    at baseline and after 8 weeks (at the completion of the intervention)

  • Pain

    at baseline and after 8 weeks (at the completion of the intervention)

  • Sleep disturbances

    at baseline and after 8 weeks (at the completion of the intervention)

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy (CBT)

2

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

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

1
Usual CareBEHAVIORAL

Subjects receive Usual Care for 8 weeks followed by CBT

2

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergone CABG at one of our recruitment sites

You may not qualify if:

  • Less than 45 years of age
  • Have cognitive impairment or major comorbid psychiatric conditions
  • Have autoimmune disorder or malignancy
  • Currently smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90027, United States

Location

Kaiser Permanente Medical Center - Sunset

Los Angeles, California, 90027, United States

Location

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

Los Angeles, California, 90073, United States

Location

University of California, Los Angeles School of Nursing

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • 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.

    PMID: 24979578DERIVED

  • 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.

    PMID: 24763358DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lynn Doering, RN, DNSc

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

July 1, 2005

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(5)