Stress Clinical Trial
Official title:
Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients With Inflammatory Bowel Diseases
Verified date | October 2023 |
Source | Mayo Clinic |
Contact | Alana English |
Phone | 507-538-9459 |
Irlbeck.Alana[@]mayo.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Corticosteroids in the previous 3 months - Elicit substance use (including medical marijuana) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Minnesota | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, approximately 20 weeks |
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