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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WSU-022413B3E

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