Status:
COMPLETED
SMART Program in Irritable Bowel Syndrome (IBS)
Lead Sponsor:
University of California, Los Angeles
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a pilot study to determine the efficacy of the Stress Management and Resilience Training (SMART) program in improving gastrointestinal and psychological symptoms, health-related quality of lif...
Detailed Description
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain related to defecation and associated with changes in stool frequency and/or form. IBS is a stre...
Eligibility Criteria
Inclusion
- Those with a diagnosis of IBS based on the Rome IV diagnostic criteria (recurrent abdominal pain at least once per week in the last 3 months associated with 2 of the following: related to defecation, associated with a change in stool frequency, associated with a change in stool form. Symptoms must have started 6 months prior to presentation)
- Between the ages of 18 and 70
- English speaking
- Are able to provide written, informed consent
- At least moderate IBS symptoms (based on an IBS symptom severity scale score \[IBS-SSS\] of 175 or higher)
- At least moderate levels of perceived stress (based on a perceived stress score of 14 or higher
- If receiving pharmacologic therapy for IBS, they must be on a stable dose for 30 days prior to enrollment
Exclusion
- History of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease
- History of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal \>6 months ago)
- Poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia
- Currently receiving, or have received in the last 6 months, other stress reduction therapies such as mindfulness based stress reduction, meditation
- Excessive alcohol intake (up to 1 drink per day for females and 2 drinks per day for males)
- Illicit substance use
- High dose opiate use
- Pregnancy
- Non-English speaking
- Inability to provide written informed consent
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03454386
Start Date
July 1 2018
End Date
February 2 2020
Last Update
June 1 2020
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095