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A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome

A Six-Month Study to Compare Outcome Differences and Visceral Response in Subjects Randomized to a Psychological Intervention for Irritable Bowel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00368771
Enrollment
163
Registered
2006-08-25
Start date
2002-07-31
Completion date
2010-05-31
Last updated
2016-11-28

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, Abdominal Pain, Abdominal Discomfort, Diarrhea, Constipation, IBS

Brief summary

The purpose of this study is to assess the effect of participation in one of the following interventions: (1) IBS Stress Management; (2) IBS Symptom Management; or (3) IBS Educational Training on improving IBS associated symptoms. It is anticipated that this research will provide information on the usefulness of psychological approaches in treating IBS and will help scientists better understand the disorder.

Interventions

BEHAVIORALIBS Stress Management

If randomly assigned to this intervention, the session with the therapist will consist of training about IBS symptoms and their relationship to stress, as well as skills training in relaxation and ways of identifying and challenging mistaken thoughts about life events. The goal of this treatment is to lessen mental and physical stressful reactions to daily events, and therefore lessen IBS symptoms as a reaction to stress. The patient will be encouraged to apply relaxation skills to stressful situations.

BEHAVIORALIBS Symptom Management

If assigned to this group, the therapist will discuss feelings, over-attention to IBS symptoms, and your fear of IBS symptoms. Patients will learn how to identify thoughts that may increase your IBS symptoms and will practice how to change these thoughts to ones that make them feel more comfortable. The sessions will focus on reactions to daily life that in turn result in IBS Symptoms.

BEHAVIORALIBS Educational Training

Those assigned to this group will be given educational materials about IBS and will discuss the reading material with the therapist. The reading topics include information on gut disorders, anatomy and physiology of the gut, assessment procedures, and how to manage IBS symptoms. Sessions will also consist of weekly reviews of daily records and IBS symptoms. The goal of this intervention is to provide educational training about IBS.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Irritable Bowel Syndrome

Exclusion criteria

* GI pathology (organic disease) that affects bowel transit * Co-morbid pain disorders * Current or recent history (within 24 months) of drug or alcohol abuse * Clinical evidence (including physical exam, laboratory tests) of significant medical disease that may interfere with the patient successfully completing the trial * Planned use of drugs or agents that affect GI motility and/or perception

Design outcomes

Primary

MeasureTime frame
Changes in Symptoms14 days

Secondary

MeasureTime frame
IBS-specific Quality of Life increase14 days
IBS-Specific Beliefs and Coping14 days

Outcome results

None listed

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