NCT00005575|CompletedPhase 3
Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
Psychophysiological Interactions in Non-Cardiac Chest Pain
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Psychophysiological Interactions in Non-Cardiac Chest Pain
Sponsor study identifier
Secondary identifiers
interventional
N/A
1 country
1
Study Start
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
May 1, 2000
Actual (reported)May 2, 2000
Actual (reported)December 2002
Date type not reportedThis date has not been verified as actual or estimated.
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Bradley LA, Richter JE, Scarinci IC, Haile JM, Schan CA. Psychosocial and psychophysical assessments of patients with unexplained chest pain. Am J Med. 1992 May 27;92(5A):65S-73S. doi: 10.1016/0002-9343(92)80059-9.
Mayou RA, Bryant BM, Sanders D, Bass C, Klimes I, Forfar C. A controlled trial of cognitive behavioural therapy for non-cardiac chest pain. Psychol Med. 1997 Sep;27(5):1021-31. doi: 10.1017/s0033291797005254.
Laurence A. Bradley
University of Alabama at Birmingham
First Submitted
May 1, 2000
First Posted
May 2, 2000
Study Start
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Understanding Pediatric Chest Pain and Other Symptoms
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Cannon RO 3rd, Quyyumi AA, Mincemoyer R, Stine AM, Gracely RH, Smith WB, Geraci MF, Black BC, Uhde TW, Waclawiw MA, et al. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 May 19;330(20):1411-7. doi: 10.1056/NEJM199405193302003.
Last Updated
January 13, 2010
Record last verified: 2010-01
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