Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
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|ClinicalTrials.gov Identifier: NCT00005575|
Recruitment Status : Completed
First Posted : May 2, 2000
Last Update Posted : January 13, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain||Drug: Imipramine Behavioral: Cognitive-behavior therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Psychophysiological Interactions in Non-Cardiac Chest Pain|
|Study Start Date :||January 1999|
|Estimated Study Completion Date :||December 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005575
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Laurence A. Bradley||University of Alabama at Birmingham|