Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome

NCT00738920 | Completed Results DMC

• 2 other identifiers: DK77738U01DK077738
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)

  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.

  2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up

Secondary Outcomes (2)

• Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)

  Baseline, 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up

• Client Satisfaction Questionnaire (CSQ)

  2-Week Follow-Up

Study Arms (3)

MC-CBT

ACTIVE COMPARATOR

Self Administered Cognitive Behavior Therapy

Behavioral: Self Administered Cognitive Behavior Therapy

Standard-CBT

ACTIVE COMPARATOR

Therapist Administered Cognitive Behavior Therapy

Behavioral: Therapist Administered Cognitive Behavior Therapy

Education/Support

ACTIVE COMPARATOR

Behavioral Patient Education/Counseling

Behavioral: Behavioral Education and Supportive Therapy

Interventions

Self Administered Cognitive Behavior Therapy BEHAVIORAL

This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS

MC-CBT

Therapist Administered Cognitive Behavior Therapy BEHAVIORAL

This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS

Standard-CBT

Behavioral Education and Supportive Therapy BEHAVIORAL

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

Education/Support

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Northwestern University Feinberg School of Medicine: collaborator
• Frontier Science & Technology Research Foundation, Inc.: collaborator
• RTI International: collaborator

Study Sites (2)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University at Buffalo School of Medicine

Buffalo, New York, 14215, United States

Location

Related Publications (3)

• Jacobs JP, Gupta A, Bhatt RR, Brawer J, Gao K, Tillisch K, Lagishetty V, Firth R, Gudleski GD, Ellingson BM, Labus JS, Naliboff BD, Lackner JM, Mayer EA. Cognitive behavioral therapy for irritable bowel syndrome induces bidirectional alterations in the brain-gut-microbiome axis associated with gastrointestinal symptom improvement. Microbiome. 2021 Nov 30;9(1):236. doi: 10.1186/s40168-021-01188-6.

  PMID: 34847963 DERIVED

• Lackner JM, Jaccard J, Keefer L, Brenner DM, Firth RS, Gudleski GD, Hamilton FA, Katz LA, Krasner SS, Ma CX, Radziwon CD, Sitrin MD. Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. Gastroenterology. 2018 Jul;155(1):47-57. doi: 10.1053/j.gastro.2018.03.063. Epub 2018 Apr 25.

  PMID: 29702118 DERIVED

• Lackner JM, Keefer L, Jaccard J, Firth R, Brenner D, Bratten J, Dunlap LJ, Ma C, Byroads M; IBSOS Research Group. The Irritable Bowel Syndrome Outcome Study (IBSOS): rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome. Contemp Clin Trials. 2012 Nov;33(6):1293-310. doi: 10.1016/j.cct.2012.07.013. Epub 2012 Jul 28.

  PMID: 22846389 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jeffrey Lackner
• Organization: University at Buffalo, SUNY

lackner@buffalo.edu

716-898-5671

Study Officials

• Jeffrey Lackner, PsyD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

• Laurie Keefer, Ph.D.

  Ichan School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Jeffrey Lackner, Psy.D.

  State University of New York at Buffalo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: August 31, 2017
• Last Updated: August 5, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (2)