Clinical trial NCT03454386: SMART Program in Irritable Bowel Syndrome (IBS)
Official title: Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome (IBS)
Stress
Resilience
Stress Management and Resilience Training Program (SMART)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in perceived stress score from baseline
timeFrame: Week 12 (end of the SMART program)
Secondary outcomes:
measure: Change in perceived stress score from baseline
timeFrame: Week 4
measure: IBS symptom severity responder rate
timeFrame: Week 4, week 12
measure: IBS related quality of life responder rate
timeFrame: Week 4, week 12
measure: Change from baseline in resilience scores as measured by the Brief Resilience scale
timeFrame: Week 4, week 12
measure: Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale
timeFrame: Week 4, week 12
measure: Change from baseline in adaptive resilience score
timeFrame: Week 4, week 12
measure: Change in gratitude scores from baseline
timeFrame: Week 4, week 12
measure: Change in mindfulness scores from baseline
timeFrame: Week 4, week 12
measure: Change in patient satisfaction from baseline
timeFrame: Week 4, week 12
measure: Change in anxiety symptoms from baseline
timeFrame: Week 4, week 12
measure: Change in gastrointestinal symptom related anxiety from baseline
timeFrame: Week 4, week 12
measure: Change in somatic symptom severity from baseline
timeFrame: Week 4, week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Lin Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: