Treatment of Depression After Coronary Bypass Surgery

Depression Clinical Trial

Official title:

Treatment of Depression After Coronary Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042198
• Other study ID #: R01MH060735
• Secondary ID: R01MH060735DSIR
• Status: Completed
• Phase: N/A
• First received: July 24, 2002
• Last updated: July 1, 2013
• Start date: December 2001
• Est. completion date: August 2006

Study information

• Verified date: July 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Cognitive behavior therapy
Up to 12 weekly, individual, hour-long sessions
• Supportive Stress Management
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1001/arc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression (HAM-D-17)	The HAM-D-17 is an observer-rated measure of the severity of depression.	12 weeks post-randomization	No
Secondary	Beck Depression Inventory	The BDI is a self-report measure of the severity of depression.	12 weeks post-randomization	No
Secondary	Beck Anxiety Inventory	The BAI is a self-report measure of the severity of anxiety symptoms.	12 weeks post-randomization	No
Secondary	Beck Hopelessness Scale	The BHS is a self-report measure of hopelessness.	12 weeks post-randomization	No
Secondary	Perceived Stress Scale	The PSS is a self-report measure of perceived stress	12 weeks post-randomization	No
Secondary	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.	12 weeks post-randomization	No

External Links

•   Volunteer for Health--Washington University's research volunteer program