SMART Program in Irritable Bowel Syndrome (IBS)

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Stress Management and Resilience Training Program; Behavioral: Self-Management Stress Reduction Program

• Registration Number: NCT03454386
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Study Start: 2018-07-01
• Primary Completion: 2019-11-07
• Study Completion: 2020-02-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Stress Management and Resilience Training Program	Stress Management and Resilience Training Program This group will be initially enrolled in the program.
Control	Self-Management Stress Reduction Program	Self-Management Stress Reduction Program This group will be placed in a self-management stress reduction program. During this time these participants will be given a popular stress reduction book to read over 12 weeks. They will complete questionnaires at weeks 4 and 12. After the 12 weeks, this group will be enrolled in the online SMART program and complete assessments at week 24 (upon completion of the program.

Primary Outcome Measures

Name	Time	Method
Change in perceived stress score from baseline	Week 12 (end of the SMART program)	Validated questionnaire with 10 questions regarding respondents stress levels

Secondary Outcome Measures

Name	Time	Method
Change in perceived stress score from baseline	Week 4	Validated questionnaire with 10 questions regarding respondents stress levels
Change from baseline in adaptive resilience score	Week 4, week 12	A validated questionnaire to measure adaptive resilience will be used
Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale	Week 4, week 12	The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
Change in patient satisfaction from baseline	Week 4, week 12	The measurement of patient satisfaction will be adapted from the patient global satisfaction scale from the Hospital Consumer Assessment of Healthcare Providers and Systems.
Change in gastrointestinal symptom related anxiety from baseline	Week 4, week 12	Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
Change in anxiety symptoms from baseline	Week 4, week 12	Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
Change in mindfulness scores from baseline	Week 4, week 12	Mindfulness will be measured using the validated five factor mindfulness questionnaire
IBS symptom severity responder rate	Week 4, week 12	IBS symptom severity will be measured using the validated IBS symptom severity score. A participant will be consider a responder if they have a 50 point reduction in their baseline score.
IBS related quality of life responder rate	Week 4, week 12	IBS related quality of life will be measure using a validated questionnaire. A participant is considered a responder if there is a 14 point improvement in their baseline score
Change from baseline in resilience scores as measured by the Brief Resilience scale	Week 4, week 12	The Brief Resilience scale is a 6 question validated questionnaire
Change in gratitude scores from baseline	Week 4, week 12	Gratitude will be measured using a validated questionnaire.
Change in somatic symptom severity from baseline	Week 4, week 12	Somatic symptom severity will be measured using the validated patient health questionnaire

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States