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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy(CBT)
Sponsored by
Michigan Gastroenterology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michigan Gastroenterology Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Treatment

Arm Description

Patients in this group will receive conventional treatment for IBS, including anti-diarrhea agents, laxatives, bulking agents and anti-spasmodic.

Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT

Outcomes

Primary Outcome Measures

IBS Quality of Life Inventory(IBS QOLF)
Significant improvement in IBS QOLF score in the treatment group

Secondary Outcome Measures

Behavioral Symptom Inventory
improvement in emotional function

Full Information

First Posted
February 15, 2011
Last Updated
February 15, 2011
Sponsor
Michigan Gastroenterology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01297556
Brief Title
Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.
Acronym
IBS
Official Title
Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Michigan Gastroenterology Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in this group will receive conventional treatment for IBS, including anti-diarrhea agents, laxatives, bulking agents and anti-spasmodic.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy(CBT)
Intervention Description
Cognitive Behavior Therapy(CBT) for 6 weeks.
Primary Outcome Measure Information:
Title
IBS Quality of Life Inventory(IBS QOLF)
Description
Significant improvement in IBS QOLF score in the treatment group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Behavioral Symptom Inventory
Description
improvement in emotional function
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iftiker Ahmad, M.D.
Phone
517.332.1200
Ext
221
Email
ahmadi@msu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Priscilla Wade, Ph.D
Phone
517.336.7366
Email
consultation.services@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iftiker Ahmad, M.D.
Organizational Affiliation
Michigan Gastroenterology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Gastroenterology Institute
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iftiker Ahmad, M.D.
Phone
517-332-1200
Ext
221
First Name & Middle Initial & Last Name & Degree
Iftiker Ahmad, M.D.

12. IPD Sharing Statement

Citations:
Citation
1. Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Treatments for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. J Consult Psychol. 2004;72(6):1100-1113. 2. Spiller R, Aziz Q, Creed F, et al. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut. 2007;56(12):1770-98. 3. Zijdenbos IL, de Wit NJ, van der Heijden GJ, Rubin G, Quartero AO. Psychological treatments for the management of irritable bowel syndrome. Cochrane Database Syst Rev. 2009;(1):CD006442. 4. Jones R, Latinovic R, Charlton J, Gulliford M. Physical and psychological co-morbidity in irritable bowel syndrome: a matched cohort study using the General Practice Research Database. Aliment Pharmachol Ther. 2006;24(5):879-886. 5.Jailwala J, Imperiale TF, Kroenke K. Pharmacologic treatment of the irritable bowel syndrome: a systematic review of randomized, controlled trials. Ann Intern Med. 2000 Jul 18;133(2):136-47. Review. PMID: 10896640 6. 6. Spanier JA, Howden CW, Jones MP. A Systematic Review of Alternative Therapies in the Irritable Bowel Syndrome. Arch Intern Med. 2003;163(3):265-674. 7.Blanchard EB, Scharf L. Psychosocial aspects of assessment and treatment of irritable bowel syndrome in adults and recurrent abdominal pain in children. J Consult Psychol. 2002;70(3):725-738. 8. Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Blanchard EB. How does cognitive behavior therapy for irritable bowel syndrome work? A mediational analysis of a randomized clinical trial. Gastroenterology. 2007 Aug;133(2):433-44. Epub 2007 May 21. PMID: 17681164
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Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.

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