Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
Participant gender:
Summary
Approximately 75,000-150,000 patients each year in the United States undergo intensive
cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings.
These patients often have high levels of disability and suffering and account for
$250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence
from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of
training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term
reductions in pain intensity. However, no studies have compared the effects of these two
treatments on measures of pain, suffering, and disability at post-treatment and over a
one-year follow-up period.
Our investigation is a 16-week, randomized controlled outcome study of these interventions
and their respective placebo control procedures. One hundred and sixty patients are being
recruited for this study. We will assess the effects of our interventions on patients' pain
levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month
follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our
treatment effects as well as their statistical significance.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)