- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248586
Development of Limited Contact CBT Treatment for IBS
October 11, 2017 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 (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.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 (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.
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 Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14215
- UB, SUNY School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion criteria. To be included in the investigation, patients will have to: (a) be between the ages of 18 and 70 years of age; (b) meet Rome II criteria (66) for irritable bowel syndrome whose symptoms occur at least 2 days per week for 6 months or greater; (c) have a minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT); (d) be willing to sign a consent form stating their willingness to participate in and participate in all phases of the investigation; (e) take either no IBS medications, or if taking medications, be on a stable dose for at least three months prior to trial entry with an understanding that dosage be maintained at pretreatment level(s) unless change is medically necessary.
Exclusion Criteria:
- Exclusion criteria. Patients will be excluded from the study if they (a) are undergoing concurrent psychological therapy and are unwilling or unable to stop treatment for the duration of the study; (b) have a history of having previously received actual CBT treatments being evaluated in the study, (c) have a diagnosed organic GI disorder or show current suicidality, substance abuse, psychosis in which case they will be referred for appropriate treatment; (e) are intellectually unable or unwilling to complete daily GI ratings
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
EXPERIMENTAL: Standard CBT (S-CBT)
|
Standard CBT (S-CBT) is a skills-based training program delivered to patients in 10 weekly, 1-hour sessions.
|
EXPERIMENTAL: Minimal contact CBT (MC-CBT)
|
Minimal contact CBT (MC-CBT) covers the same range of procedures featured in S-CBT but relies extensively on self study materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate relief - abdominal pain
Time Frame: 12 weeks
|
In the past 7 days, have you had adequate relief from irritable bowel syndrome pain or discomfort?" (Yes/No).
|
12 weeks
|
Global symptom improvement
Time Frame: 12 weeks
|
Compared to how you felt prior to entering the study, how would you rate the IBS symptoms for which you sought treatment during the past week?"
(1, substantially improved; 4, no change; 7, substantially worse).
Consistent with past research, we defined treatment responders a priori by a score of 1 (substantially) or 2 (moderately improved)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBS Quality of life
Time Frame: 12 weeks
|
12 weeks
|
|
Psychological distress
Time Frame: 12 weeks
|
Global Severity Index of the Brief Symptom Inventory
|
12 weeks
|
IBS Symptom severity
Time Frame: 12 weeks
|
IBS Symptom Severity Scale
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey Lackner, PsyD, UB, SUNY
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Holroyd K. Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroenterol Hepatol. 2008 Aug;6(8):899-906. doi: 10.1016/j.cgh.2008.03.004. Epub 2008 Jun 4.
- Lackner JM, Gudleski GD, Keefer L, Krasner SS, Powell C, Katz LA. Rapid response to cognitive behavior therapy predicts treatment outcome in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2010 May;8(5):426-32. doi: 10.1016/j.cgh.2010.02.007. Epub 2010 Feb 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2005
Primary Completion (ACTUAL)
July 1, 2006
Study Completion (ACTUAL)
July 1, 2006
Study Registration Dates
First Submitted
November 1, 2005
First Submitted That Met QC Criteria
November 2, 2005
First Posted (ESTIMATE)
November 4, 2005
Study Record Updates
Last Update Posted (ACTUAL)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- R03 DK67878 (completed 2007)
- R03DK067878 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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