Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) State University of New York at Buffalo Feinberg School of Medicine, Northwestern University University of Alabama at Birmingham Frontier Science RTI International |
---|---|
Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00738920 |
The primary goal of the proposed trial is to assess the short- and long-term efficacy of cognitive behavior therapy (CBT) for irritable bowel syndrome using two treatment delivery systems (self administered, therapist administered). Secondary aims seek to specify the conditions under which CBT may (or may not) achieve its effects (moderator questions), why and how these effects are achieved (mediator questions) and at what economic cost.
Long term project goals are to develop an effective self-administered behavioral treatment program that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable GI disorders.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome |
Behavioral: Self Administered Cogntive Behavior Therapy Behavioral: Therapist Administered Cogntive Behavior Therapy Behavioral: Education/Support |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Self Administered CBT for IBS: A Multisite Trial |
Estimated Enrollment: | 480 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | May 2015 |
Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Self Administered Cogntive Behavior Therapy
|
Behavioral: Self Administered Cogntive Behavior Therapy |
2: Active Comparator
Therapist Administered Cogntive Behavior Therapy
|
Behavioral: Therapist Administered Cogntive Behavior Therapy |
3
Education/Support
|
Behavioral: Education/Support |
Irritable bowel syndrome (IBS) is a chronic, prevalent, often disabling, GI disorder for which there is no reliable and satisfactory medical option for its full range of symptoms (abdominal pain, bowel dysfunction). An accumulating body of evidence indicates that a specific psychosocial treatment called cognitive behavioral therapy (CBT) is associated with significant reductions in IBS symptoms and related difficulties. Despite its apparent efficacy, CBT's clinical effectiveness (i.e., 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. In a pilot study funded under NIDDK's R03 mechanism, we addressed these problems by developing a briefer, largely self administered version of CBT that requires only 4, I hr clinic visits. Our RCT data showed that a 10 session version of CBT can be translated into a 4 session version without compromising patient acceptability or short term efficacy. It is unclear whether treatment effects are maintained long term (out to 12 months), due to theoretical change mechanisms (vs.
nonspecific factors common across different forms of therapy), are more pronounced among specific subgroups of patients, or, generalize to a large sample of Rome III diagnosed patients treated by different investigative sites. We seek to address these questions by conducting a larger, more definitive, multisite RCT that will recruit from 3 treatment sites 480 patients with moderate to severe IBS and assess their acute and long term response to brief (4 session) CBT, extended (10 session) CBT, or a credible attention placebo. We will use the first year to develop a clinical infrastructrue to ensure the success and integrity of the proposed trial. In the short term, a successful trial will lend empirical validation to a self administered version of CBT that retains the efficacy of standard CBT but is more transportable, accessible to patients outside of research protocols, and less costly to deliver. In the long term, we hope to show that a self guided behavioral treatment program is an effective and efficient treatment delivery system that can enhance the quality of patient care, improve clinical outcomes, and decrease the economic and personal costs of one of the most prevalent and intractable GI disorders.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey M Lackner, Psy.D. | 716-898-5671 | lackner@buffalo.edu |
Contact: Rebecca S Firth, MS | 716-898-6254 | rsfirth@buffalo.edu |
Responsible Party: | University at Buffalo, SUNY ( Jeffrey Lackner ) |
Study ID Numbers: | 077738 |
Study First Received: | August 19, 2008 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00738920 History of Changes |
Health Authority: | United States: Federal Government |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Digestive System Diseases Gastrointestinal Diseases Syndrome |
Colonic Diseases Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |