Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248586
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2005-11-01
Brief Title:
Development of Limited Contact CBT Treatment for IBS
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:
Development of Limited Contact CBT Treatment for IBS
Status:
COMPLETED
Status Verified Date:
2017-10
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:
An accumulating body of evidence indicates that a specific psychological treatment called cognitive behavioral therapy CBT is associated with significant reductions in pain and bowel dysfunction of irritable bowel syndrome IBS Despite its apparent efficacy the clinical effectiveness of CBT ie its generalizability feasibility cost effectiveness has not been adequately established due partly to its duration cost and limited accessibility As the second generation of IBS treatments undergo development and validation it has become increasingly clear that efficacy demonstration is a necessary but not sufficient condition of treatment viability One potential solution to the problem of clinical effectiveness is to develop a briefer largely self administered version of CBT that retains the efficacy of standard CBT but is more transportable accessible and less costly to deliver To this end a two-stage project is proposed The goals of the first stage will be to develop refine and pilot test an innovative limited therapist contact-CBT protocol patterned after treatments proven effective for painful medical disorders with similar pathophysiology as IBS The primary aim of the second stage is to conduct a small randomized clinical trial N 75 patients meeting Rome II diagnostic criteria of standard 10 session version of CBT S-CBT and limited contact 4 session version of CBT LC-CBT with reference to a wait list control to examine their comparative efficacy on multiple indices including IBS symptoms primary outcome variable psychological distress and quality of life Secondary aims are 1 to identify patient characteristics that predict outcome 2 obtain information regarding active change-inducing mechanisms that may underlie treatment outcome and 3 obtain information regarding possible monetary benefits cost-effectiveness and cost-benefit of S-CBT versus LC-CBT protocols Data from this trial would set the stage for an R01 funded multicenter study with a large random and representative sample that could establish the clinical effectiveness of LC-CBT and in so doing make a significant contribution toward more efficient and effective care of IBS
Detailed Description:
An accumulating body of evidence indicates that a specific psychological treatment called cognitive behavioral therapy CBT is associated with significant reductions in pain and bowel dysfunction of irritable bowel syndrome IBS Despite its apparent efficacy the clinical effectiveness of CBT ie its generalizability feasibility cost effectiveness has not been adequately established due partly to its duration cost and limited accessibility As the second generation of IBS treatments undergo development and validation it has become increasingly clear that efficacy demonstration is a necessary but not sufficient condition of treatment viability One potential solution to the problem of clinical effectiveness is to develop a briefer largely self administered version of CBT that retains the efficacy of standard CBT but is more transportable accessible and less costly to deliver To this end a two-stage project is proposed The goals of the first stage will be to develop refine and pilot test an innovative limited therapist contact-CBT protocol patterned after treatments proven effective for painful medical disorders with similar pathophysiology as IBS The primary aim of the second stage is to conduct a small randomized clinical trial N 75 patients meeting Rome II diagnostic criteria of standard 10 session version of CBT S-CBT and limited contact 4 session version of CBT LC-CBT with reference to a wait list control to examine their comparative efficacy on multiple indices including IBS symptoms primary outcome variable psychological distress and quality of life Secondary aims are 1 to identify patient characteristics that predict outcome 2 obtain information regarding active change-inducing mechanisms that may underlie treatment outcome and 3 obtain information regarding possible monetary benefits cost-effectiveness and cost-benefit of S-CBT versus LC-CBT protocols Data from this trial would set the stage for an R01 funded multicenter study with a large random and representative sample that could establish the clinical effectiveness of LC-CBT and in so doing make a significant contribution toward more efficient and effective care of IBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03DK067878 | NIH | None | httpsreporternihgovquickSearchR03DK067878 |