Skip to content

Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.

Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01297556
Acronym
IBS
Enrollment
200
Registered
2011-02-16
Start date
2011-04-30
Completion date
2011-12-31
Last updated
2011-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome

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.

Interventions

BEHAVIORALCognitive Behavior Therapy(CBT)

Cognitive Behavior Therapy(CBT) for 6 weeks.

Sponsors

Michigan Gastroenterology Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
IBS Quality of Life Inventory(IBS QOLF)6 monthsSignificant improvement in IBS QOLF score in the treatment group

Secondary

MeasureTime frameDescription
Behavioral Symptom Inventory6 monthsimprovement in emotional function

Countries

United States

Contacts

Primary ContactIftiker Ahmad, M.D.
ahmadi@msu.edu517.332.1200
Backup ContactPriscilla Wade, Ph.D
consultation.services@gmail.com517.336.7366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026