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SMART Program in Irritable Bowel Syndrome (IBS)

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ClinicalTrials.gov Identifier: NCT03454386
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Lin Chang, MD, 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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454386


Contacts
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Contact: Nafeesa Islam 310-206-1656 nislam@mednet.ucla.edu
Contact: Lin Chang, MD 310-206-1656 linchang@mednet.ucla.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Nafeesa Islam    310-206-1656    nislam@mednet.ucla.edu   
Principal Investigator: Lin Chang, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Lin Chang, MD University of California, Los Angeles

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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     History of Changes
Other Study ID Numbers: IRB#18-000235
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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