Status:
NOT_YET_RECRUITING
Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological ...
Detailed Description
Prior to conducting the randomized pilot study, as part of Aim 1, patient focus groups will be conducted, based on the IBD social-cognitive model (IBD SCM), with a prototype DMBI to assess resonance a...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- self-identify as Black/African American and/or Hispanic/Latino(a/x)
- diagnosed with Crohn's disease or ulcerative colitis
- ability to provide informed consent in English
- elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.
Exclusion
- Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.
- Current suicidality, past suicide attempt, or psychiatric hospitalization.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06510296
Start Date
July 1 2026
End Date
September 1 2028
Last Update
August 13 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467