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SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06002074
Enrollment
17
Registered
2023-08-21
Start date
2023-09-28
Completion date
2024-09-27
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Stress

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.

Interventions

One-on-one stress management and resilience consultation by a certified SMART trainer followed by self-guided on-line training consisting of 4 modules.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)Baseline, approximately 20 weeksMeasured 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026