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SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT06002074
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stress Management and Resilience Training Program
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients With Inflammatory Bowel Diseases
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stress management and resilience training

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.

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.
Other Names:
  • SMART

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Shayla Schoenoff, PA-C, MS, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Shayla A. Schoenoff, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT06002074
    Other Study ID Numbers:
    • 23-004024
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Aug 21, 2023