Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
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ClinicalTrials.gov Identifier: NCT00738920 |
Recruitment Status :
Completed
First Posted : August 21, 2008
Results First Posted : July 6, 2022
Last Update Posted : August 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Irritable Bowel Syndrome | Behavioral: Self Administered Cognitive Behavior Therapy Behavioral: Therapist Administered Cognitive Behavior Therapy Behavioral: Behavioral Education and Supportive Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 436 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Self Administered CBT for IBS: A Multisite Trial |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | August 31, 2017 |
Arm | Intervention/treatment |
---|---|
Active Comparator: MC-CBT
Self Administered Cognitive Behavior Therapy
|
Behavioral: Self Administered Cognitive Behavior Therapy
This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS |
Active Comparator: Standard-CBT
Therapist Administered Cognitive Behavior Therapy
|
Behavioral: Therapist Administered Cognitive Behavior Therapy
This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS |
Active Comparator: Education/Support
Behavioral Patient Education/Counseling
|
Behavioral: Behavioral Education and Supportive Therapy
This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor |
- Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version) [ Time Frame: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up ]The CGI-I is a single-item, 7-point centered scale that integrates symptom severity and improvement since the start of treatment. Specific IBS-based anchor points were used, as is the convention for multi-symptom disease states. Response range from 1 (very much worse) to 7 (very much improved), with higher scores indicating greater symptom improvement. Participants who respond 6 (much improved) or 7 (very much improved) are classified as treatment responders.
- Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS) [ Time Frame: Baseline, 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up ]The IBS-SSS is a 5-item instrument used to measure severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOL. For four of the items, respondents mark a point on a 101 mm visual analogue scale to indicate their response to that item. The proportional distance from zero is the score (ranging from 0 to 100) assigned for that scale. The other item asks the number of days out of 10 the patient experiences abdominal pain and the answer is multiplied by 10 to create a 0 to 100 metric. The five items are summed and the total scores range from 0-500, with higher scores signifying more severe symptoms [mild (<175), moderate (175-300), severe (>300)]. A decrease of 50 points on the IBS-SSS is considered clinically significant.
- Client Satisfaction Questionnaire (CSQ) [ Time Frame: 2-Week Follow-Up ]The CSQ is an 8-item questionnaire that measures patient satisfaction with treatment. Scores range from 8 to 32 with higher scores indicating greater satisfaction with treatment.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738920
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
University at Buffalo School of Medicine | |
Buffalo, New York, United States, 14215 |
Principal Investigator: | Jeffrey Lackner, PsyD | State University of New York at Buffalo | |
Principal Investigator: | Laurie Keefer, Ph.D. | Ichan School of Medicine at Mount Sinai | |
Study Chair: | Jeffrey Lackner, Psy.D. | State University of New York at Buffalo |
Responsible Party: | Jeffrey Lackner, Principal investigator, State University of New York at Buffalo |
ClinicalTrials.gov Identifier: | NCT00738920 |
Other Study ID Numbers: |
DK77738 U01DK077738 ( U.S. NIH Grant/Contract ) |
First Posted: | August 21, 2008 Key Record Dates |
Results First Posted: | July 6, 2022 |
Last Update Posted: | August 5, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | One of the main goals of the IBSOS is to establish a central repository of data for subsequent hypothesis-based research designed to enable the widest dissemination of data, while also protecting the privacy of the participants and the utility of the data by de-identification and masking of potentially sensitive data elements. To support these objectives we will catalog and provide basic results sets through the NIDDK repository www.niddkrepository.org, as well as create and deliver more comprehensive de-identified data sets, for each completed aim of the IBSOS study. Study data will be provided in SAS/SPSS format and will be named to match corresponding codebooks or dictionary and study forms, which will also be located within the Repository. Codebooks will include variable names and labels, where applicable. For analysis data sets, we will provide documentation for analyses conducted for manuscript publication as well as descriptive summaries for main variables. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Baseline data: September 1, 2018 Primary outcome manuscript: May 1, 2018 Entire dataset from intervention study: September 1, 2019 |
Access Criteria: | All applications for access of these data sets must be submitted through an application to NIDDK central repository as outlined on their website www.niddkrepository.org. Access for the data submitted to the NIDDK Data Repository will be determined by the NIDDK. All investigators who receive IBSOS resources must agree to acknowledge the IBSOS Study and the NIDDK central repository. |
Irritable Bowel Syndrome Syndrome Disease Pathologic Processes Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |