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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
Last Update Posted : October 4, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Feinberg School of Medicine, Northwestern University
Frontier Science & Technology Research Foundation, Inc.
RTI International
Information provided by (Responsible Party):
Jeffrey Lackner, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE August 19, 2008
First Posted Date  ICMJE August 21, 2008
Last Update Posted Date October 4, 2017
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
Global improvement of IBS symptoms (CGI) [ Time Frame: 2 weeks after treatment ends and at 3, 6, 9. and 12 months after treatment ends ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
Quality of life (SF-36; IBS-QOL) Psychological distress (BSI) Coping (CSQ, Advere Events Cost Health Care utilization Patient Satisfaction (CSQ) Stool consistency (BSFS) Daily patient assessent of IBS symptoms [ Time Frame: 2 weeks after treatment ends and at 3, 6, 9. and 12 months after treatment ends ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
Official Title  ICMJE Self Administered CBT for IBS: A Multisite Trial
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.
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 education/support 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Behavioral: Self Administered Cognitive Behavior Therapy
    This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
  • Behavioral: Therapist Administered Cognitive Behavior Therapy
    This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
  • 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
Study Arms  ICMJE
  • Active Comparator: MC-CBT
    Self Administered Cognitive Behavior Therapy
    Intervention: Behavioral: Self Administered Cognitive Behavior Therapy
  • Active Comparator: Standard-CBT
    Therapist Administered Cognitive Behavior Therapy
    Intervention: Behavioral: Therapist Administered Cognitive Behavior Therapy
  • Active Comparator: Education/Support
    Behavioral Patient Education/Counseling
    Intervention: Behavioral: Behavioral Education and Supportive Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2016)
462
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2008)
480
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00738920
Other Study ID Numbers  ICMJE DK77738
U01DK077738 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jeffrey Lackner, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Feinberg School of Medicine, Northwestern University
  • Frontier Science & Technology Research Foundation, Inc.
  • RTI International
Investigators  ICMJE
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
PRS Account State University of New York at Buffalo
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP