Treatment of Depression After Coronary Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenneth Freedland, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00042198
First received: July 24, 2002
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Depression
Coronary Disease
Behavioral: Cognitive behavior therapy
Behavioral: Supportive Stress Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression After Coronary Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The HAM-D-17 is an observer-rated measure of the severity of depression.


Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The BDI is a self-report measure of the severity of depression.

  • Beck Anxiety Inventory [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The BAI is a self-report measure of the severity of anxiety symptoms.

  • Beck Hopelessness Scale [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The BHS is a self-report measure of hopelessness.

  • Perceived Stress Scale [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The PSS is a self-report measure of perceived stress

  • SF-36 [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported.


Enrollment: 123
Study Start Date: December 2001
Study Completion Date: August 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Behavioral: Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
Active Comparator: 2
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.
Behavioral: Supportive Stress Management
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors
No Intervention: 3
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.

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042198

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kenneth E Freedland, Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Kenneth Freedland, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00042198     History of Changes
Other Study ID Numbers: R01 MH60735, R01MH060735, DSIR AT-AS
Study First Received: July 24, 2002
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
Cognitive therapy
Relaxation techniques

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Depression
Depressive Disorder
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014