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NCT06002074 Clinical Trial

SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06002074
Other study ID # 23-004024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2023
Est. completion date August 2024

Study information
Verified date October 2023
Source Mayo Clinic
Contact Alana English
Phone 507-538-9459
Email Irlbeck.Alana@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
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)

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Stress Management and Resilience Training Program
One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
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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