Treatment of Depression After Coronary Bypass Surgery

Not Applicable

Completed

• Conditions: Depression; Coronary Disease
• Interventions: Behavioral: Cognitive behavior therapy; Behavioral: Supportive Stress Management

• Registration Number: NCT00042198
• Lead Sponsor: Washington University School of Medicine

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).

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-07-24
• Study First Submitted QC: 2002-07-25
• Study First Posted: 2002-07-26
• Primary Completion: 2005-12
• Study Completion: 2006-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive behavior therapy	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.
2	Supportive Stress Management	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAM-D-17)	12 weeks post-randomization	The HAM-D-17 is an observer-rated measure of the severity of depression.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory	12 weeks post-randomization	The BDI is a self-report measure of the severity of depression.
Beck Anxiety Inventory	12 weeks post-randomization	The BAI is a self-report measure of the severity of anxiety symptoms.
Beck Hopelessness Scale	12 weeks post-randomization	The BHS is a self-report measure of hopelessness.
Perceived Stress Scale	12 weeks post-randomization	The PSS is a self-report measure of perceived stress
SF-36	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States