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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: IBS Educational Training; Behavioral: IBS Symptom Management; Behavioral: IBS Stress Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00368771

DK-NR07768

R01NR007768 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 3 patient groups

1

Active Comparator group

Description:

IBS Stress Management

Treatment:

Behavioral: IBS Stress Management

2

Active Comparator group

Description:

IBS Symptom Management

Treatment:

Behavioral: IBS Symptom Management

3

Active Comparator group

Description:

IBS Educational Training

Treatment:

Behavioral: IBS Educational Training