Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by State University of New York at Buffalo
Sponsor:
Collaborators:
Feinberg School of Medicine, Northwestern University
Frontier Science
RTI International
Information provided by (Responsible Party):
Jeffrey Lackner, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00738920
First received: August 19, 2008
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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 Cognitive Behavior Therapy
Behavioral: Therapist Administered Cognitive Behavior Therapy
Behavioral: Behavioral Education and Supportive Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self Administered CBT for IBS: A Multisite Trial

Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Global improvement of IBS symptoms (CGI) [ Time Frame: 2 weeks after treatment ends and at 3, 6, 9. and 12 months after treatment ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (SF-36; IBS-QOL; Psychological distress (BSI); IBS Symptom Severity (IBSSSS); Coping (CSQ), Adverse Events; Cost; Health Care utilization; Patient Satisfaction (CSQ; Stool consistency (BSFS); Stool frequency; Abdominal Pain; [ Time Frame: 2 weeks after treatment ends and at 3, 6, 9. and 12 months after treatment ends ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
Study Start Date: August 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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: 2
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: 3
Behavioral Patient Education/Counseling
Behavioral: Behavioral Education and Supportive Therapy
This 4 session treatment emphasizes support, information giving about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor

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, 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, 1 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 2 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 control condition. We will use the first year to develop a clinical infrastructure 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738920

Contacts
Contact: Jeffrey M Lackner, Psy.D. 716-898-5671 lackner@buffalo.edu
Contact: Rebecca S Firth, MHA 716-898-6254 rsfirth@buffalo.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Jason Bratten    312-695-2742    IBSOS@northwestern.edu   
Principal Investigator: Laurie Keefer, Ph.D.         
Sub-Investigator: Darren Brenner, MD         
United States, New York
University at Buffalo School of Medicine Recruiting
Buffalo, New York, United States, 14215
Contact: Rebecca Firth    716-898-6254    IBSOS@buffalo.edu   
Principal Investigator: Jeffrey M Lackner, Psy.D.         
Sub-Investigator: Susan S Krasner, Ph.D.         
Sub-Investigator: Leonard Katz, MD         
Sub-Investigator: Michael Sitrin, MD         
Sub-Investigator: Ann Marie Carosella, Ph.D.         
Sponsors and Collaborators
State University of New York at Buffalo
Feinberg School of Medicine, Northwestern University
Frontier Science
RTI International
Investigators
Principal Investigator: Jeffrey Lackner, PsyD State University of New York at Buffalo
Principal Investigator: Laurie Keefer, Ph.D. Northwestern University
Study Chair: Jeffrey Lackner, Psy.D. State University of New York at Buffalo
  More Information

No publications provided by State University of New York at Buffalo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Lackner, Principal investigator, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00738920     History of Changes
Other Study ID Numbers: DK77738, U01DK077738
Study First Received: August 19, 2008
Last Updated: November 17, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014