Clinical trial NCT01886027: Stress Management for Irritable Bowel Syndrome
Official title: Stress Management for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Relaxation
Emotional exposure
Emotional Processing
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: IBS symptom severity scale (IBS-SSS)
timeFrame: Change from baseline symptom severity at 1 month and 3 months
Secondary outcomes:
measure: McGill Pain Questionnaire, Short Form (SF-MPQ-2)
timeFrame: Change from baseline pain at 1 month and 3 months
measure: Bristol Stool Form Scale (BSFS)
timeFrame: Change from baseline stool form at 1 month and 3 months
measure: Irritable Bowel Syndrome, Quality of Life (IBS-QOL)
timeFrame: Change from baseline quality of life at 1 month and 3 months
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Change from baseline positive affect and negative affect at 1 month and 3 months
measure: Impact of Events Scale - Revised (IES-R)
timeFrame: Change from baseline impact of events at 1 month and 3 months
measure: Toronto Alexithymia Scale -20 (TAS-20)
timeFrame: Change from baseline alexithymia at 1 month and 3 months
measure: Rathus Assertiveness Schedule (RAS)
timeFrame: Change from baseline assertiveness at 1 month and 3 months
measure: Ambivalence over Emotional Expression Scale (AEQ)
timeFrame: Change from baseline ambivalence over emotional expression at 1 month and 3 months
measure: Emotional Approach Coping Scale (EAC)
timeFrame: Change from baseline emotional approach coping at 1 month and 3 months
measure: IBS self-efficacy questionnaire
timeFrame: Change from baseline self-efficacy at 1 month and 3 months
measure: Communicating Thoughts and Feelings Questionnaire
timeFrame: Change from baseline ability to communicate thoughts and feelings at 1 month and 3 months
measure: Clinical Global Impressions (CGI) Improvement Scale - IBS version
timeFrame: Change from baseline IBS symptoms at 1 month and 3 months
measure: Health care Utilization Scale
timeFrame: Change in health care utilization from baseline to 1-month and 3-month follow-ups
measure: Brief Symptom Inventory
timeFrame: Change in psychological symptoms from baseline to 1-month and 3-month follow-ups
measure: Early Trauma Inventory Self-Report Short Form
timeFrame: Change in Trauma reports from baseline to 1-month and 3-month follow-ups
measure: Experiences in Close Relationships Questionnaire
timeFrame: Change in attachment from baseline to 1-month and3-month follow-ups
measure: General Social Constraints Scale
timeFrame: Change in social constraints from baseline to 1-month and 3-month follow-ups
measure: Medication use
timeFrame: Change in medication use from baseline to 1-month and 3-month follow-ups
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark A. Lumley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.