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SMART Program in Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management and Resilience Training Program
Self-Management Stress Reduction Program
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome (IBS), Stress, Resilience, Stress Management and Resilience Training Program (SMART)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Active Treatment

Control

Arm Description

Stress Management and Resilience Training Program This group will be initially enrolled in the 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.

Outcomes

Primary Outcome Measures

Change in perceived stress score from baseline
Validated questionnaire with 10 questions regarding respondents stress levels

Secondary Outcome Measures

Change in perceived stress score from baseline
Validated questionnaire with 10 questions regarding respondents stress levels
IBS symptom severity responder rate
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
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
The Brief Resilience scale is a 6 question validated questionnaire
Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale
The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
Change from baseline in adaptive resilience score
A validated questionnaire to measure adaptive resilience will be used
Change in gratitude scores from baseline
Gratitude will be measured using a validated questionnaire.
Change in mindfulness scores from baseline
Mindfulness will be measured using the validated five factor mindfulness questionnaire
Change in patient satisfaction from baseline
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 anxiety symptoms from baseline
Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
Change in gastrointestinal symptom related anxiety from baseline
Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
Change in somatic symptom severity from baseline
Somatic symptom severity will be measured using the validated patient health questionnaire

Full Information

First Posted
February 26, 2018
Last Updated
May 29, 2020
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03454386
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
February 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome (IBS), Stress, Resilience, Stress Management and Resilience Training Program (SMART)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Stress Management and Resilience Training Program This group will be initially enrolled in the program.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resilience Training Program
Other Intervention Name(s)
SMART Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Management Stress Reduction Program
Intervention Description
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 Measure Information:
Title
Change in perceived stress score from baseline
Description
Validated questionnaire with 10 questions regarding respondents stress levels
Time Frame
Week 12 (end of the SMART program)
Secondary Outcome Measure Information:
Title
Change in perceived stress score from baseline
Description
Validated questionnaire with 10 questions regarding respondents stress levels
Time Frame
Week 4
Title
IBS symptom severity responder rate
Description
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.
Time Frame
Week 4, week 12
Title
IBS related quality of life responder rate
Description
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
Time Frame
Week 4, week 12
Title
Change from baseline in resilience scores as measured by the Brief Resilience scale
Description
The Brief Resilience scale is a 6 question validated questionnaire
Time Frame
Week 4, week 12
Title
Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale
Description
The Connor-Davidson Resilience Scale is a 25 question validated questionnaire
Time Frame
Week 4, week 12
Title
Change from baseline in adaptive resilience score
Description
A validated questionnaire to measure adaptive resilience will be used
Time Frame
Week 4, week 12
Title
Change in gratitude scores from baseline
Description
Gratitude will be measured using a validated questionnaire.
Time Frame
Week 4, week 12
Title
Change in mindfulness scores from baseline
Description
Mindfulness will be measured using the validated five factor mindfulness questionnaire
Time Frame
Week 4, week 12
Title
Change in patient satisfaction from baseline
Description
The measurement of patient satisfaction will be adapted from the patient global satisfaction scale from the Hospital Consumer Assessment of Healthcare Providers and Systems.
Time Frame
Week 4, week 12
Title
Change in anxiety symptoms from baseline
Description
Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
Time Frame
Week 4, week 12
Title
Change in gastrointestinal symptom related anxiety from baseline
Description
Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
Time Frame
Week 4, week 12
Title
Change in somatic symptom severity from baseline
Description
Somatic symptom severity will be measured using the validated patient health questionnaire
Time Frame
Week 4, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Chang, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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SMART Program in Irritable Bowel Syndrome (IBS)

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