Stress Management for Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Awareness and Expression Training
Relaxation Training
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Relaxation, Emotional exposure, Emotional Processing
Eligibility Criteria
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.
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Emotional Awareness and Expression
Relaxation
Wait-list control
Arm Description
Emotional awareness and expression training (EAET) is an emotional processing intervention.
Relaxation training will teach patients different relaxation training skills.
Standard medical care until the 3-month follow-up is completed
Outcomes
Primary Outcome Measures
IBS symptom severity scale (IBS-SSS)
Secondary Outcome Measures
McGill Pain Questionnaire, Short Form (SF-MPQ-2)
Bristol Stool Form Scale (BSFS)
Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
Positive and Negative Affect Scale (PANAS)
Impact of Events Scale - Revised (IES-R)
Toronto Alexithymia Scale -20 (TAS-20)
Rathus Assertiveness Schedule (RAS)
Ambivalence over Emotional Expression Scale (AEQ)
Emotional Approach Coping Scale (EAC)
IBS self-efficacy questionnaire
Communicating Thoughts and Feelings Questionnaire
Clinical Global Impressions (CGI) Improvement Scale - IBS version
Health care Utilization Scale
Brief Symptom Inventory
Early Trauma Inventory Self-Report Short Form
Experiences in Close Relationships Questionnaire
General Social Constraints Scale
Medication use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01886027
Brief Title
Stress Management for Irritable Bowel Syndrome
Official Title
Stress Management for Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS, Relaxation, Emotional exposure, Emotional Processing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emotional Awareness and Expression
Arm Type
Experimental
Arm Description
Emotional awareness and expression training (EAET) is an emotional processing intervention.
Arm Title
Relaxation
Arm Type
Active Comparator
Arm Description
Relaxation training will teach patients different relaxation training skills.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Standard medical care until the 3-month follow-up is completed
Intervention Type
Behavioral
Intervention Name(s)
Emotional Awareness and Expression Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.
Primary Outcome Measure Information:
Title
IBS symptom severity scale (IBS-SSS)
Time Frame
Change from baseline symptom severity at 1 month and 3 months
Secondary Outcome Measure Information:
Title
McGill Pain Questionnaire, Short Form (SF-MPQ-2)
Time Frame
Change from baseline pain at 1 month and 3 months
Title
Bristol Stool Form Scale (BSFS)
Time Frame
Change from baseline stool form at 1 month and 3 months
Title
Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
Time Frame
Change from baseline quality of life at 1 month and 3 months
Title
Positive and Negative Affect Scale (PANAS)
Time Frame
Change from baseline positive affect and negative affect at 1 month and 3 months
Title
Impact of Events Scale - Revised (IES-R)
Time Frame
Change from baseline impact of events at 1 month and 3 months
Title
Toronto Alexithymia Scale -20 (TAS-20)
Time Frame
Change from baseline alexithymia at 1 month and 3 months
Title
Rathus Assertiveness Schedule (RAS)
Time Frame
Change from baseline assertiveness at 1 month and 3 months
Title
Ambivalence over Emotional Expression Scale (AEQ)
Time Frame
Change from baseline ambivalence over emotional expression at 1 month and 3 months
Title
Emotional Approach Coping Scale (EAC)
Time Frame
Change from baseline emotional approach coping at 1 month and 3 months
Title
IBS self-efficacy questionnaire
Time Frame
Change from baseline self-efficacy at 1 month and 3 months
Title
Communicating Thoughts and Feelings Questionnaire
Time Frame
Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months
Title
Clinical Global Impressions (CGI) Improvement Scale - IBS version
Time Frame
Change from baseline IBS symptoms at 1 month and 3 months
Title
Health care Utilization Scale
Time Frame
Change in health care utilization from baseline to 1-month and 3-month follow-ups
Title
Brief Symptom Inventory
Time Frame
Change in psychological symptoms from baseline to 1-month and 3-month follow-ups
Title
Early Trauma Inventory Self-Report Short Form
Time Frame
Change in Trauma reports from baseline to 1-month and 3-month follow-ups
Title
Experiences in Close Relationships Questionnaire
Time Frame
Change in attachment from baseline to 1-month and3-month follow-ups
Title
General Social Constraints Scale
Time Frame
Change in social constraints from baseline to 1-month and 3-month follow-ups
Title
Medication use
Time Frame
Change in medication use from baseline to 1-month and 3-month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Lumley, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28643436
Citation
Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.
Results Reference
derived
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Stress Management for Irritable Bowel Syndrome
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