Irritable Bowel SyndromeNCT03454386
SMART Program in Irritable Bowel Syndrome (IBS)
A study testing Stress Management and Resilience Training Program and Self-Management Stress Reduction Program in people with Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Stress Management and Resilience Training Program and Self-Management Stress Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 2 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- High dose opiate use
- Pregnancy
- Non-English speaking
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Stress Management and Resilience Training Program, Self-Management Stress Reduction Program
- Keywords
- Irritable Bowel Syndrome (IBS), Stress, Resilience, Stress Management and Resilience Training Program (SMART)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Resilience Training ProgramBehavioural
Also called SMART 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.
Self-Management Stress Reduction ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Stress Management and Resilience Training Program
This group will be initially enrolled in the program. Receives: Behavioral: Stress Management and Resilience Training Program |
| Control | Other | 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. Receives: Behavioral: Self-Management Stress Reduction Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress score from baseline
Validated questionnaire with 10 questions regarding respondents stress levels
Measured: Week 12 (end of the SMART program)
Secondary outcomes (12)
Change in perceived stress score from baseline
Validated questionnaire with 10 questions regarding respondents stress levels
Measured: Week 4
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.
Measured: Week 4, week 12
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
Measured: Week 4, week 12
Change from baseline in resilience scores as measured by the Brief Resilience scale
The Brief Resilience scale is a 6 question validated questionnaire
Measured: Week 4, week 12
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
Measured: Week 4, week 12
Change from baseline in adaptive resilience score
A validated questionnaire to measure adaptive resilience will be used
Measured: Week 4, week 12
Change in gratitude scores from baseline
Gratitude will be measured using a validated questionnaire.
Measured: Week 4, week 12
Change in mindfulness scores from baseline
Mindfulness will be measured using the validated five factor mindfulness questionnaire
Measured: Week 4, week 12
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.
Measured: Week 4, week 12
Change in anxiety symptoms from baseline
Anxiety symptoms will be measured using the validated hospital anxiety and depression questionnaire
Measured: Week 4, week 12
Change in gastrointestinal symptom related anxiety from baseline
Gastrointestinal symptom related anxiety will be measured using the validated visceral sensitivity index
Measured: Week 4, week 12
Change in somatic symptom severity from baseline
Somatic symptom severity will be measured using the validated patient health questionnaire
Measured: Week 4, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Jul 2018
- Primary completion7 Nov 2019
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chang, MD, University of California, Los Angeles
- Investigators
- Lin Chang, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454386
- Sponsor's protocol ID
- IRB#18-000235
- Status last verified
- May 2020
- First submitted
- 26 Feb 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Stress Management and Resilience Training (SMART) Program in the Management of Irritable Bowel Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT03454386
- Acronym / sponsor ID
- IRB#18-000235
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome (IBS), Stress, Resilience, Stress Management and Resilience Training Program (SMART)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Behavioral: Stress Management and Resilience Training ProgramStress Management and Resilience Training Program This group will be initially enrolled in the program. |
| Control | Other | Behavioral: Self-Management Stress Reduction ProgramSelf-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Management and Resilience Training ProgramAlso: SMART ProgramThis 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. | Behavioural | Active Treatment |
| Self-Management Stress Reduction ProgramProgram 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. | Behavioural | Control |
Primary outcome
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
12 secondary outcomes
Change in perceived stress score from baseline
Time frame: Week 4
IBS symptom severity responder rate
Time frame: Week 4, week 12
IBS related quality of life responder rate
Time frame: Week 4, week 12
Change from baseline in resilience scores as measured by the Brief Resilience scale
Time frame: Week 4, week 12
Change from baseline in resilience score as measured by the Connor-Davidson Resilience Scale
Time frame: Week 4, week 12
Change from baseline in adaptive resilience score
Time frame: Week 4, week 12
Change in gratitude scores from baseline
Time frame: Week 4, week 12
Change in mindfulness scores from baseline
Time frame: Week 4, week 12
Change in patient satisfaction from baseline
Time frame: Week 4, week 12
Change in anxiety symptoms from baseline
Time frame: Week 4, week 12
Change in gastrointestinal symptom related anxiety from baseline
Time frame: Week 4, week 12
Change in somatic symptom severity from baseline
Time frame: Week 4, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chang, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management and Resilience Training Program and Self-Management Stress Reduction Program in people with Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress score from baseline (time frame: Week 12 (end of the SMART program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.