SMART Program in Irritable Bowel Syndrome (IBS)



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:10/13/2018
Start Date:July 1, 2018
End Date:December 2019
Contact:Nafeesa Islam
Email:nislam@mednet.ucla.edu
Phone:310-206-1656

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Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study

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.

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 stress sensitive disorder and its severity has been shown to be moderated by
both acute and chronic stress. Furthermore, resilience, which is defined as the ability to
positively adapt and thrive in the presence of stressors and adversity, has been shown to be
lower in those with IBS and associated with more severe symptoms. Therapies aimed at stress
reduction in IBS have been found to be effective in the management of IBS. To our knowledge,
there are no reports in the literature of a therapy to target resilience in the IBS patient
population.

The Stress Management and Resilience Training (SMART) program was developed by Dr. A. Sood at
the Mayo clinic to reduce stress, decrease symptoms related to stress and enhance resiliency.
This is accomplished by targeting human attention and interpretation of events, people and
the world. Furthermore, methods to strengthen the skills of gratitude, compassion,
acceptance, forgiveness and understanding of a higher meaning are taught. Previous studies
have demonstrated that this program can improve stress, anxiety, resilience and quality of
life of participants.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Lin Chang, MD
Phone: 310-206-1656
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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