Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome. (IBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Michigan Gastroenterology Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Michigan Gastroenterology Institute
ClinicalTrials.gov Identifier:
NCT01297556
First received: February 15, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Cognitive Behavior Therapy(CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome.

Further study details as provided by Michigan Gastroenterology Institute:

Primary Outcome Measures:
  • IBS Quality of Life Inventory(IBS QOLF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Significant improvement in IBS QOLF score in the treatment group


Secondary Outcome Measures:
  • Behavioral Symptom Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    improvement in emotional function


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Patients in this group will receive conventional treatment for IBS, including anti-diarrhea agents, laxatives, bulking agents and anti-spasmodic.
Experimental: Treatment
Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT
Behavioral: Cognitive Behavior Therapy(CBT)
Cognitive Behavior Therapy(CBT) for 6 weeks.
Other Name: Cognitive Behavior Therapy(CBT)

Detailed Description:

Although research has demonstrated the efficacy of various psychological and pharmacological treatments for irritable bowel syndrome (IBS)1, health professionals have limited information about how to determine which specific treatment regimens lead to optimal outcomes for specific IBS populations 2,3. A prevalent syndrome, with high healthcare costs, IBS is a debilitating chronic functional bowel disorder with increasingly interconnected psychosocial and gastrointestinal afflictions4. In general, IBS sufferers have not been found to respond consistently to a single medication or class of medications5. In the wake of the failures of medical therapies, many psychological interventions, adjunct to standard IBS treatments, have been examined1,6 such as Blanchard and Scharff's 2002 review of 12 random controlled trials that found strong evidence for the utility of hypnotherapy, cognitive behavioral therapy (CBT), and brief psychodynamic psychotherapy in helping to alleviate IBS symptoms7. Similarly, in a more recent study involving a meta-analysis of seventeen studies, with randomized trials comparing classes of psychological interventions, found that these psychological treatments also play a role in improving quality of life of IBS suffers1. Among these psychological interventions, cognitive behavioral therapy (CBT), a prescriptive therapy that specifically targets faulty thinking patterns, has been found to be quite effective in many empirical investigations. Recent evaluations of CBT interventions have found the therapy to have a direct effect on global improvements of IBS symptoms and quality of life8. Despite its demonstrated effectiveness, however, CBT does not work for all patients3,6,8. The successes of medical therapy alone compared to a treatment regimen combining psychological and pharmaceutical interventions have been greeted with mixed results— leading to the unnecessary waste of health resources in the course of treatment3,6. To decrease medical costs, as well to foster optimal treatment for IBS patients, there is a need for a better method of identifying which patients will most benefit from specific treatment options s (i.e. conventional medical treatment versus standard treatment and CBT)2,3.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All newly diagnosed IBS patients using Rome III criteria above the age of 18.

Exclusion Criteria:

  • Patients with non-functional GI disorders, severe psychiatric disorders, including psychotic disorders, actively suicidal or alcoholism/other drug dependencies.
  • Pregnant women and minors(under age 18) will also be excluded.
  • Prisoners will also be excluded.
  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: NCT01297556

Contacts
Contact: Iftiker Ahmad, M.D. 517.332.1200 ext 221 ahmadi@msu.edu
Contact: Priscilla Wade, Ph.D 517.336.7366 consultation.services@gmail.com

Locations
United States, Michigan
Michigan Gastroenterology Institute Not yet recruiting
East Lansing, Michigan, United States, 48823
Contact: Iftiker Ahmad, M.D.    517-332-1200 ext 221      
Principal Investigator: Iftiker Ahmad, M.D.         
Sponsors and Collaborators
Michigan Gastroenterology Institute
Investigators
Principal Investigator: Iftiker Ahmad, M.D. Michigan Gastroenterology Institute
  More Information

No publications provided

Responsible Party: Iftiker Ahmad, M.D., Michigan Gastroenterology Institute
ClinicalTrials.gov Identifier: NCT01297556     History of Changes
Other Study ID Numbers: MGI-IKA-IBS-2011
Study First Received: February 15, 2011
Last Updated: February 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan Gastroenterology Institute:
Irritable Bowel Syndrome

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

ClinicalTrials.gov processed this record on October 01, 2014