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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IBS Stress Management
IBS Symptom Management
IBS Educational Training
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Abdominal Pain, Abdominal Discomfort, Diarrhea, Constipation, IBS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    IBS Stress Management

    IBS Symptom Management

    IBS Educational Training

    Outcomes

    Primary Outcome Measures

    Changes in Symptoms

    Secondary Outcome Measures

    IBS-specific Quality of Life increase
    IBS-Specific Beliefs and Coping

    Full Information

    First Posted
    August 24, 2006
    Last Updated
    November 23, 2016
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00368771
    Brief Title
    A Six-month Study to Compare Outcome Differences and Visceral Response ... Irritable Bowel Syndrome
    Official Title
    A Six-Month Study to Compare Outcome Differences and Visceral Response in Subjects Randomized to a Psychological Intervention for Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Nursing Research (NINR)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome
    Keywords
    Irritable Bowel Syndrome, Abdominal Pain, Abdominal Discomfort, Diarrhea, Constipation, IBS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    163 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    IBS Stress Management
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    IBS Symptom Management
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    IBS Educational Training
    Intervention Type
    Behavioral
    Intervention Name(s)
    IBS Stress Management
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    IBS Symptom Management
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    IBS Educational Training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in Symptoms
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    IBS-specific Quality of Life increase
    Time Frame
    14 days
    Title
    IBS-Specific Beliefs and Coping
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruce D Naliboff, PhD
    Organizational Affiliation
    University of California Los Angeles, West Los Angeles VA Healthcare System
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michelle G Craske, PhD
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21565328
    Citation
    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.2011.04.001. Epub 2011 Apr 19.
    Results Reference
    result
    Links:
    URL
    http://uclacns.org
    Description
    Related Info

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

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