SMART Program in Irritable Bowel Syndrome (IBS)

• ClinicalTrials.gov Identifier: NCT03454386
• Recruitment Status: Completed
• First Posted: March 5, 2018
• Last Update Posted: June 1, 2020
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Lin Chang, MD, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Behavioral: Stress Management and Resilience Training Program; Behavioral: Self-Management Stress Reduction Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: November 7, 2019
• Actual Study Completion Date: February 2, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active Treatment; Stress Management and Resilience Training Program This group will be initially enrolled in the program.	Behavioral: Stress Management and Resilience Training Program; This program targets attention and interpretation of events, people and the world through the skills of gratitude, compassion, acceptance, forgiveness and understanding of a higher meaning. The program involves two phases. The 4 week "training phase" begins with a group session that discusses the practices that can be used to enhance awareness and engagement through the principles listed above. Participants will receive twice weekly emails with videos that described a different practice for participants to use in their daily lives. The second phase is the "sustain phase" that is 8 weeks in duration. Participants are expected to continue using the daily practices learned during the training phase. Weekly emails will be sent with ways to incorporate these practices into their daily lives.; Other Name: SMART Program
Control; 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.	Behavioral: Self-Management Stress Reduction Program; Program participants will be given a popular stress reduction book to read over a 12 week period. Upon completion of this, they will be enrolled in the online SMART program for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. Change in perceived stress score from baseline [ Time Frame: Week 12 (end of the SMART program) ]
   Validated questionnaire with 10 questions regarding respondents stress levels

Secondary Outcome Measures :

1. Change in perceived stress score from baseline [ Time Frame: Week 4 ]
   Validated questionnaire with 10 questions regarding respondents stress levels
2. IBS symptom severity responder rate [ Time Frame: 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.
3. IBS related quality of life responder rate [ Time Frame: 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
4. Change from baseline in resilience scores as measured by the Brief Resilience scale [ Time Frame: Week 4, week 12 ]
   The Brief Resilience scale is a 6 question validated questionnaire
5. Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale [ Time Frame: Week 4, week 12 ]
   The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
6. Change from baseline in adaptive resilience score [ Time Frame: Week 4, week 12 ]
   A validated questionnaire to measure adaptive resilience will be used
7. Change in gratitude scores from baseline [ Time Frame: Week 4, week 12 ]
   Gratitude will be measured using a validated questionnaire.
8. Change in mindfulness scores from baseline [ Time Frame: Week 4, week 12 ]
   Mindfulness will be measured using the validated five factor mindfulness questionnaire
9. Change in patient satisfaction from baseline [ Time Frame: 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.
10. Change in anxiety symptoms from baseline [ Time Frame: Week 4, week 12 ]
    Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
11. Change in gastrointestinal symptom related anxiety from baseline [ Time Frame: Week 4, week 12 ]
    Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
12. Change in somatic symptom severity from baseline [ Time Frame: Week 4, week 12 ]
    Somatic symptom severity will be measured using the validated patient health questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

UCLA

Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Lin Chang, MD; University of California, Los Angeles

More Information

• Responsible Party: Lin Chang, MD, Co-Director, G. Oppenheimer Center for Neurobiology of Stress and Resilience, Vatche and Tamar Manoukian Division of Digestive Diseases, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03454386
• Other Study ID Numbers: IRB#18-000235
• First Posted: March 5, 2018
• Last Update Posted: June 1, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lin Chang, MD, University of California, Los Angeles:

Irritable Bowel Syndrome (IBS); Stress; Resilience; Stress Management and Resilience Training Program (SMART)

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases