SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

Not Applicable

Terminated

• Conditions: Stress; Inflammatory Bowel Diseases
• Interventions: Behavioral: Stress Management and Resilience Training Program

• Registration Number: NCT06002074
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-21
• Study Start: 2023-09-28
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

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Exclusion Criteria

• Corticosteroids in the previous 3 months
• Elicit substance use (including medical marijuana)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress management and resilience training	Stress Management and Resilience Training Program	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.

Primary Outcome Measures

Name	Time	Method
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)	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.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States