Status:
COMPLETED
Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University Feinberg School of Medicine
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 admini...
Detailed Description
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, bowe...
Eligibility Criteria
Inclusion
- Males or female patients aged 18 to 70 years (inclusive);
- All ethnic groups;
- Meet Rome III criteria for IBS with symptoms of at least moderate severity (at least 2 days per week);
- Ability to understand and provide informed consent;
- With the exception of antibiotics, participant is willing to remain on a stable dose only through the 4-week pretreatment baseline period prior to randomization;
- Participant either not taking medications or if taking medications willing to suspend starting any new medications only during the initial 4-week pretreatment baseline period;
- Participant demonstrates an ability to speak understand and read, English a the sixth grade level or higher;
- Willingness to be randomized to CBT or Support/Education to which s/he has been assigned to to adhere to protocol requirements;
- Participant is willing to attend regularly scheduled therapy session during active phase of the trial;
- Participant is willing to be contacted and scheduled for follow-up assessment at week 12 and 3, 6, 9, and 12 months after the conclusion of acute treatment phase;
- Participant is willing and able to enter symptom information into an assigned portable computer and complete questionnaires through treatment and at regularly scheduled follow ups
- Participant has access to a telephone; and
- Participant is willing and able to provide adequate information for locator purposes.
Exclusion
- Evidence of current structural or biochemical abnormalities or medication use that better explain the participant's IBS symptoms (e.g. IBD);
- Evidence of a current infection or infection of any type within the 2 weeks prior to the study gastroenterologists' evaluation which would obscure the presentation of IBS symptoms. In such cases the baseline can be delayed until 2 weeks after complete recovery.
- Participant has received antibiotics (e.g. rifaximin and or neomycin) specifically targeted to treat IBS symptoms within the past 3 months. In this instance eligibility will be suspended for 12 weeks from the initial date the antibiotic was consumed.
- Participant has undergone previous abdominal surgery that would have caused significant alternation of the anatomy/physiology of the digestive/GI tract, which adequately explains GI symptoms;
- Participant has been diagnosed and/or treated for malignancy in the past 5 years with the exception of localized basal or squamous cell carcinomas of the skin;
- Participant has an unstable extraintestinal medical condition whose immediate or foreseeable treatment needs (e.g., hospitalization, conflicting physician visits) would realistically interfere with study demands (e.g., consistent attendance at treatment sessions and/or ability to participate in telephone interventions) or may affect the interpretation of clinical efficacy data;
- Participant has a major psychiatric disorder, which in the opinion of the senior clinical staff may impede conduct of the clinical trial. These disorders include but are not limited to major depression diagnosis with a high risk of suicidal behavior (i.e. intent or plan), alcohol or substance abuse/dependence within the past year, a lifetime history of schizophrenia or schizoaffective disorder or gross cognitive impairments;
- Participant has other conditions which in the opinion of the senior clinical staff would influence negatively the conduct of the clinical trial;
- Participant is currently receiving targeted psychotherapy for IBS and is unwilling or unable to discontinue his/her treatment for the acute treatment phase of this study;
- Participant is unable to complete all scheduled screening visits; and participant is inaccessible for interventions and/or follow-up evaluations.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT00738920
Start Date
August 1 2010
End Date
August 31 2017
Last Update
August 5 2022
Active Locations (2)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
University at Buffalo School of Medicine
Buffalo, New York, United States, 14215