Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005575
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2000-05-01
Brief Title:
Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Psychophysiological Interactions in Non-Cardiac Chest Pain
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 75000-150000 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 250000000-500000000 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 42428-06 | None | None | None |