Stress Management for Irritable Bowel Syndrome
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 6, 2015
May 1, 2015
1.7 years
June 13, 2013
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IBS symptom severity scale (IBS-SSS)
Change from baseline symptom severity at 1 month and 3 months
Secondary Outcomes (18)
McGill Pain Questionnaire, Short Form (SF-MPQ-2)
Change from baseline pain at 1 month and 3 months
Bristol Stool Form Scale (BSFS)
Change from baseline stool form at 1 month and 3 months
Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
Change from baseline quality of life at 1 month and 3 months
Positive and Negative Affect Scale (PANAS)
Change from baseline positive affect and negative affect at 1 month and 3 months
Impact of Events Scale - Revised (IES-R)
Change from baseline impact of events at 1 month and 3 months
- +13 more secondary outcomes
Study Arms (3)
Emotional Awareness and Expression
EXPERIMENTALEmotional awareness and expression training (EAET) is an emotional processing intervention.
Relaxation
ACTIVE COMPARATORRelaxation training will teach patients different relaxation training skills.
Wait-list control
NO INTERVENTIONStandard medical care until the 3-month follow-up is completed
Interventions
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.
Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University
Detroit, Michigan, 48067, United States
Related Publications (1)
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.
PMID: 28643436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A. Lumley, Ph.D.
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 13, 2013
First Posted
June 25, 2013
Study Start
June 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 6, 2015
Record last verified: 2015-05