Clinical trial NCT00042198: Treatment of Depression After Coronary Bypass Surgery
Official title: Treatment of Depression After Coronary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Coronary Disease
Keywords: Cognitive therapy
Relaxation techniques
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-07-26
Enrollment: 123
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D-17)
timeFrame: 12 weeks post-randomization
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 12 weeks post-randomization
measure: Beck Anxiety Inventory
timeFrame: 12 weeks post-randomization
measure: Beck Hopelessness Scale
timeFrame: 12 weeks post-randomization
measure: Perceived Stress Scale
timeFrame: 12 weeks post-randomization
measure: SF-36
timeFrame: 12 weeks post-randomization
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kenneth E Freedland, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Davila-Roman 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/archgenpsychiatry.2009.7.