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N/A N=453 Randomized Triple-blind Treatment

Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

Cardiovascular Diseases · Coronary Disease · Heart Diseases · Depression

Enrolled (actual)
453
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Generic Mental Health-Related Quality of Life — 50.0; 46.2; 57.2 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Psychoeducation; Treatment recommendations (Behavioral); Pharmacotherapy (Drug); Usual Care (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Jun 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Generic Mental Health-Related Quality of Life
50.0; 46.2; 57.2
SECONDARY
Hamilton Rating Scale for Depression
9.0; 11.4; 3.8 0.001 sig
SECONDARY
Generic Physical Health-Related Quality of Life
44.0; 41.4; 48.7
SECONDARY
Disease-Specific Health-Related Quality of Life
25.2; 21.4; 33.2

Summary

The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).

Eligibility Criteria

Inclusion Criteria

  • Recently underwent CABG (combined or redo procedure) at one of 8 Pittsburgh area study hospitals
  • A PHQ score greater than 10 OR if nondepressed control, a PHQ score less than 5 at both 2 days post CABG to the date of discharge following CABG and when reassessed 2 weeks after hospital discharge
  • Folstein Mini-Mental State Examination (MMSE) score greater than or equal to 24
  • Able to be evaluated and treated for depression as an outpatient post CABG
  • Has a household telephone

Exclusion Criteria

  • Presently in treatment with a mental health specialist
  • Actively suicidal
  • History of psychotic illness
  • History of bipolar illness according to subject self-report and past medical history
  • Current alcohol dependence or other substance abuse as evidenced by chart review and the CAGE questionnaire
  • Organic mood syndromes, including those secondary to medical illness or drugs
  • Presence of non-cardiovascular conditions that are likely to be fatal within 1 year
  • Unstable medical condition as indicated by history, physical, and/or laboratory findings
  • Previous enrollment in the study cohort
  • Non-English speaking, illiterate, or possessing any other communication barrier
  • If nondepressed control, current or previous diagnosis or treatment of depression
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00091962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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