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Treatment of Depression After Coronary Bypass Surgery

Primary Purpose

Depression, Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavior therapy
Supportive Stress Management
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Cognitive therapy, Relaxation techniques

Eligibility Criteria

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

Inclusion Criteria: Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months Meets DSM-IV criteria for major or minor depressive episode Exclusion Criteria: Severe cognitive impairment Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia) Severely debilitating or life-threatening illness other than coronary disease

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

1

2

3

Arm Description

Cognitive Behavior Therapy. The treatment modality was individual, face-to-face therapy with an experienced cognitive therapist. Treatment consisted of up to 12 weekly, hour-long sessions.

Supportive Stress Management. The treatment modality was individual, face-to-face therapy with an experienced psychotherapist. Treatment consisted of up to 12 weekly, hour-long sessions.

Usual Care, minimally enhanced. Participants in all three arms were given information about depression. There were no restrictions in any of the arms on usual care for depression, heart disease, or any other conditions, except that concurrent participation in nonstudy psychotherapy was not allowed. Participants were allowed to continue or start on nonstudy antidepressants during the study, as prescribed by the participant's personal physician.

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D-17)
The HAM-D-17 is an observer-rated measure of the severity of depression.

Secondary Outcome Measures

Beck Depression Inventory
The BDI is a self-report measure of the severity of depression.
Beck Anxiety Inventory
The BAI is a self-report measure of the severity of anxiety symptoms.
Beck Hopelessness Scale
The BHS is a self-report measure of hopelessness.
Perceived Stress Scale
The PSS is a self-report measure of perceived stress
SF-36
The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported.

Full Information

First Posted
July 24, 2002
Last Updated
July 1, 2013
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00042198
Brief Title
Treatment of Depression After Coronary Bypass Surgery
Official Title
Treatment of Depression After Coronary Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.
Detailed Description
Depression is a very common problem for people who have had CABG surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Cognitive behavior therapy (CBT) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (SSM) interventions have also been shown to improve depressive symptoms. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery. Participants will be screened for depression within 1 year after CABG surgery. Those who have depression will return for additional testing 1 week later. Eligible participants will be randomized to receive CBT, SSM, or usual care (UC), with no restrictions on nonstudy antidepressants, for 12 weeks. Patients will be monitored for worsening depression referred for additional care if needed. Depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of CBT or SSM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Coronary Disease
Keywords
Cognitive therapy, Relaxation techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy. The treatment modality was individual, face-to-face therapy with an experienced cognitive therapist. Treatment consisted of up to 12 weekly, hour-long sessions.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Supportive Stress Management. The treatment modality was individual, face-to-face therapy with an experienced psychotherapist. Treatment consisted of up to 12 weekly, hour-long sessions.
Arm Title
3
Arm Type
No Intervention
Arm Description
Usual Care, minimally enhanced. Participants in all three arms were given information about depression. There were no restrictions in any of the arms on usual care for depression, heart disease, or any other conditions, except that concurrent participation in nonstudy psychotherapy was not allowed. Participants were allowed to continue or start on nonstudy antidepressants during the study, as prescribed by the participant's personal physician.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
Up to 12 weekly, individual, hour-long sessions
Intervention Type
Behavioral
Intervention Name(s)
Supportive Stress Management
Intervention Description
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D-17)
Description
The HAM-D-17 is an observer-rated measure of the severity of depression.
Time Frame
12 weeks post-randomization
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
The BDI is a self-report measure of the severity of depression.
Time Frame
12 weeks post-randomization
Title
Beck Anxiety Inventory
Description
The BAI is a self-report measure of the severity of anxiety symptoms.
Time Frame
12 weeks post-randomization
Title
Beck Hopelessness Scale
Description
The BHS is a self-report measure of hopelessness.
Time Frame
12 weeks post-randomization
Title
Perceived Stress Scale
Description
The PSS is a self-report measure of perceived stress
Time Frame
12 weeks post-randomization
Title
SF-36
Description
The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported.
Time Frame
12 weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months Meets DSM-IV criteria for major or minor depressive episode Exclusion Criteria: Severe cognitive impairment Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia) Severely debilitating or life-threatening illness other than coronary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth E Freedland, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19349308
Citation
Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Davila-Roman VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.
Results Reference
result
Links:
URL
http://vfh.wustl.edu/
Description
Volunteer for Health--Washington University's research volunteer program

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Treatment of Depression After Coronary Bypass Surgery

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