Stress Management for Irritable Bowel Syndrome

May 5, 2015 updated by: Mark A. Lumley, Wayne State University
The primary goal of this study is to test the efficacy of emotional awareness and expression training (EAET), a novel emotional processing intervention that the investigators have developed, for people with IBS. In this randomized, controlled trial, the investigators will compare EAET to a standard intervention that teaches the conceptually opposite approach-relaxation training (RT)-and test how both of these interventions compare to a wait-list control condition. The investigators hypothesize that individuals in the EAET group will demonstrate greater improvement in their IBS symptom severity, psychological functioning, quality of life, and health care utilization at 4 and 12-week follow-up time points, compared to individuals in the wait-list control group. It is also expected that both of the active interventions (EAET and RT) will be more efficacious than the wait-list control condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48067
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be eligible to participate, individuals must meet the Rome III criteria for IBS. That is, they must report that they have had:

  • recurrent abdominal pain or discomfort, or
  • a change in stool frequency or form,
  • at least three days per month, in the last three months, and
  • that they have been given this diagnosis by a physician. They must also report having pain and discomfort of at least two days per week at time of screening.

Exclusion Criteria:

  • Individuals who report having post-infectious IBS,
  • organic gastrointestinal diseases (e.g., inflammatory bowel disease), immunodeficiency,
  • a current psychotic disorder,
  • drug or alcohol dependence within the past two years, and
  • those who are unable to communicate in English will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emotional Awareness and Expression
Emotional awareness and expression training (EAET) is an emotional processing intervention.
Behavioral: Emotional Awareness and Expression Training
An emotional processing intervention, which aims to reduce stress by helping patients become aware of, and express emotions related to stressful life experiences, as well as teaching patients how to relate to others differently.
Active Comparator: Relaxation
Relaxation training will teach patients different relaxation training skills.
Behavioral: Relaxation Training
Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.
No Intervention: Wait-list control
Standard medical care until the 3-month follow-up is completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IBS symptom severity scale (IBS-SSS)
Time Frame: Change from baseline symptom severity at 1 month and 3 months
Change from baseline symptom severity at 1 month and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
McGill Pain Questionnaire, Short Form (SF-MPQ-2)
Time Frame: Change from baseline pain at 1 month and 3 months
Change from baseline pain at 1 month and 3 months
Bristol Stool Form Scale (BSFS)
Time Frame: Change from baseline stool form at 1 month and 3 months
Change from baseline stool form at 1 month and 3 months
Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
Time Frame: Change from baseline quality of life at 1 month and 3 months
Change from baseline quality of life at 1 month and 3 months
Positive and Negative Affect Scale (PANAS)
Time Frame: Change from baseline positive affect and negative affect at 1 month and 3 months
Change from baseline positive affect and negative affect at 1 month and 3 months
Impact of Events Scale - Revised (IES-R)
Time Frame: Change from baseline impact of events at 1 month and 3 months
Change from baseline impact of events at 1 month and 3 months
Toronto Alexithymia Scale -20 (TAS-20)
Time Frame: Change from baseline alexithymia at 1 month and 3 months
Change from baseline alexithymia at 1 month and 3 months
Rathus Assertiveness Schedule (RAS)
Time Frame: Change from baseline assertiveness at 1 month and 3 months
Change from baseline assertiveness at 1 month and 3 months
Ambivalence over Emotional Expression Scale (AEQ)
Time Frame: Change from baseline ambivalence over emotional expression at 1 month and 3 months
Change from baseline ambivalence over emotional expression at 1 month and 3 months
Emotional Approach Coping Scale (EAC)
Time Frame: Change from baseline emotional approach coping at 1 month and 3 months
Change from baseline emotional approach coping at 1 month and 3 months
IBS self-efficacy questionnaire
Time Frame: Change from baseline self-efficacy at 1 month and 3 months
Change from baseline self-efficacy at 1 month and 3 months
Communicating Thoughts and Feelings Questionnaire
Time Frame: Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months
Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months
Clinical Global Impressions (CGI) Improvement Scale - IBS version
Time Frame: Change from baseline IBS symptoms at 1 month and 3 months
Change from baseline IBS symptoms at 1 month and 3 months
Health care Utilization Scale
Time Frame: Change in health care utilization from baseline to 1-month and 3-month follow-ups
Change in health care utilization from baseline to 1-month and 3-month follow-ups
Brief Symptom Inventory
Time Frame: Change in psychological symptoms from baseline to 1-month and 3-month follow-ups
Change in psychological symptoms from baseline to 1-month and 3-month follow-ups
Early Trauma Inventory Self-Report Short Form
Time Frame: Change in Trauma reports from baseline to 1-month and 3-month follow-ups
Change in Trauma reports from baseline to 1-month and 3-month follow-ups
Experiences in Close Relationships Questionnaire
Time Frame: Change in attachment from baseline to 1-month and3-month follow-ups
Change in attachment from baseline to 1-month and3-month follow-ups
General Social Constraints Scale
Time Frame: Change in social constraints from baseline to 1-month and 3-month follow-ups
Change in social constraints from baseline to 1-month and 3-month follow-ups
Medication use
Time Frame: Change in medication use from baseline to 1-month and 3-month follow-ups
Change in medication use from baseline to 1-month and 3-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Principal Investigator: Mark A. Lumley, Ph.D., Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSU-022413B3E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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