Back to resultsSMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
Primary Purpose
Inflammatory Bowel Diseases, Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management and Resilience Training Program
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stress management and resilience training
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06002074
Brief Title
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
Official Title
Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients With Inflammatory Bowel Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress management and resilience training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resilience Training Program
Other Intervention Name(s)
SMART
Intervention Description
One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.
Primary Outcome Measure Information:
Title
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)
Description
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.
Time Frame
Baseline, approximately 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alana English
Phone
507-538-9459
Email
Irlbeck.Alana@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shayla Schoenoff, PA-C, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
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