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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368771
• Other study ID #: R01NR007768
• Secondary ID: R01NR007768DK-NR
• Status: Completed
• Phase: N/A
• First received: August 24, 2006
• Last updated: November 23, 2016
• Start date: July 2002
• Est. completion date: May 2010

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• IBS 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.
• IBS 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.
• IBS 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Nursing Research (NINR)

References & Publications (1)

Craske MG, Wolitzky-Taylor KB, Labus J, Wu S, Frese M, Mayer EA, Naliboff BD. A cognitive-behavioral treatment for irritable bowel syndrome using interoceptive exposure to visceral sensations. Behav Res Ther. 2011 Jun;49(6-7):413-21. doi: 10.1016/j.brat.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Symptoms		14 days	No
Secondary	IBS-specific Quality of Life increase		14 days	No
Secondary	IBS-Specific Beliefs and Coping		14 days	No

External Links

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