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OpenTrials
Completed

NCT Number: NCT00042198

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

Up to 12 weekly, individual, hour-long sessions

Supportive Stress Management

Behavioral

Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors

Primary outcomes

  1. Hamilton Rating Scale for Depression (HAM-D-17)

    Time frame: 12 weeks post-randomization

    The HAM-D-17 is an observer-rated measure of the severity of depression.

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 12 weeks post-randomization

    The BDI is a self-report measure of the severity of depression.

  2. Beck Anxiety Inventory

    Time frame: 12 weeks post-randomization

    The BAI is a self-report measure of the severity of anxiety symptoms.

  3. Beck Hopelessness Scale

    Time frame: 12 weeks post-randomization

    The BHS is a self-report measure of hopelessness.

  4. Perceived Stress Scale

    Time frame: 12 weeks post-randomization

    The PSS is a self-report measure of perceived stress

  5. SF-36

    Time frame: 12 weeks post-randomization

    The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2006
First posted
Jul 26, 2002
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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