Inflammatory Bowel DiseasesNCT06002074
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
A study testing Stress Management and Resilience Training Program in people with Inflammatory Bowel Diseases and Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Stress
- What is being tested?
- Stress Management and Resilience Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 27 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of IBD defined by a physician global assessment (PGA) of quiescent, mild, moderate, or severe disease.
- Access to internet/device such as smart phone, tablet, or computer
- Patient reports stress as a trigger to their GI symptoms
Who cannot join
- Corticosteroids in the previous 3 months
- Elicit substance use (including medical marijuana)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients with Inflammatory Bowel Diseases
This research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Diseases, Stress
- Being tested
- Stress Management and Resilience Training Program
- Medical subject headings
- Inflammatory Bowel Diseases
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
One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.
| Study group | Role | What they receive |
|---|---|---|
| Stress management and resilience training | Experimental | Subjects will receive a 1.5 hour one-on-one stress management and resilience consult by a certified SMART trainer followed by 16 week self-guided on-line training. Receives: Behavioral: Stress Management and Resilience Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)
Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life.
Measured: Baseline, approximately 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Sep 2023
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Why it stopped: PI Decision to end study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Chedid, Mayo Clinic
- Investigators
- Victor G. Chedid, M.D., M.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002074
- Sponsor's protocol ID
- 23-004024
- Status last verified
- Nov 2024
- First submitted
- 15 Aug 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients with Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT06002074
- Acronym / sponsor ID
- 23-004024
- Conditions
- Inflammatory Bowel Diseases, Stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Decision to end study
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 21 Aug 2023 (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 research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress management and resilience training | Experimental | Behavioral: Stress Management and Resilience Training ProgramSubjects will receive a 1.5 hour one-on-one stress management and resilience consult by a certified SMART trainer followed by 16 week self-guided on-line training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of IBD defined by a physician global assessment (PGA) of quiescent, mild, moderate, or severe disease.
- Access to internet/device such as smart phone, tablet, or computer
- Patient reports stress as a trigger to their GI symptoms
Key exclusion criteria (2 listed)
- Corticosteroids in the previous 3 months
- Elicit substance use (including medical marijuana)
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: SMARTOne-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules. | Behavioural | Stress management and resilience training |
Primary outcome
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)
Time frame: Baseline, approximately 20 weeks
Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life.
Results and safety
The study was stopped early (reason given: PI Decision to end study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Victor G. Chedid, M.D., M.S. principal investigator
Mayo Clinic
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 in people with Inflammatory Bowel Diseases and Stress, run by Mayo Clinic 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Nov 2024. 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 was stopped early (reason given: PI Decision to end study). Results are not available in the source record.
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 Inflammatory Bowel Disease (IBD) Quality of Life (QOL) (time frame: Baseline, approximately 20 weeks). 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 13 Nov 2024.