Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Cognitive Behavior Therapy(CBT)

• Registration Number: NCT01297556
• Lead Sponsor: Michigan Gastroenterology Institute

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.

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Last Update Submitted: 2011-02-15
• Study First Posted: 2011-02-16
• Last Update Posted: 2011-02-16
• Study Start: 2011-04
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Cognitive Behavior Therapy(CBT)	Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT

Primary Outcome Measures

Name	Time	Method
IBS Quality of Life Inventory(IBS QOLF)	6 months	Significant improvement in IBS QOLF score in the treatment group

Secondary Outcome Measures

Name	Time	Method
Behavioral Symptom Inventory	6 months	improvement in emotional function

Trial Locations

Locations (1)

Michigan Gastroenterology Institute; 🇺🇸 East Lansing, Michigan, United States