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

July 24, 2002
July 1, 2013
December 2001
December 2005   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00042198 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Treatment of Depression After Coronary Bypass Surgery
Treatment of Depression After Coronary Bypass Surgery

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Coronary Disease
  • Behavioral: Cognitive behavior therapy
    Up to 12 weekly, individual, 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
  • 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.
    Intervention: Behavioral: Cognitive behavior therapy
  • 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.
    Intervention: Behavioral: Supportive Stress Management
  • 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.
Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Dávila-Román 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
August 2006
December 2005   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042198
R01 MH60735, R01MH060735, DSIR AT-AS
Yes
Kenneth Freedland, Washington University School of Medicine
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Kenneth E Freedland, Ph.D. Washington University School of Medicine
Washington University School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP