SMART Program in Irritable Bowel Syndrome (IBS)

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome

In brief

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 life, and satisfaction of care in patients with irritable bowel syndrome (IBS). Half of the participants will be enrolled in the SMART program initially. The other half will be placed in a self-management stress reduction program where they will read a popular stress reduction book over 12 weeks. Then they will have access to participate in the online SMART program.

Key facts

Study ID

NCT03454386

Run by

University of California, Los Angeles

People needed

39

Starts

2018-07-01

Expected to finish

2020-02-02

Last updated by the study team

2020-06-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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