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Clinical Trials/NCT06002074
NCT06002074
Terminated
Not Applicable

Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients with Inflammatory Bowel Diseases

Mayo Clinic1 site in 1 country17 target enrollmentSeptember 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Diseases
Sponsor
Mayo Clinic
Enrollment
17
Locations
1
Primary Endpoint
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2023
End Date
September 27, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Victor Chedid

Principal Investigator

Mayo Clinic

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)

Outcomes

Primary Outcomes

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.

Study Sites (1)

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