ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Psychological distress and gut–brain interactions can worsen quality of life and IBD outcomes. A culturally tailored, scalable digital mind–body program could improve access to psychosocial care for Black and Hispanic patients with IBD who face barriers to traditional services.
Who Should Pay Attention
Black and Hispanic adults with Crohn’s disease or ulcerative colitis who have elevated psychological distress; gastroenterology clinicians interested in integrated behavioral care; researchers and digital health developers focused on equitable interventions.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment40 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov registration describes a planned randomized pilot study testing a digital mind-body intervention (DMBI) mobile app designed for Black and Hispanic adults with Crohn’s disease or ulcerative colitis who have elevated psychological distress.
The study will follow prior formative work (virtual focus groups and provider interviews) to develop and user-test the app, then run an 8-week pilot randomized 2:1 (DMBI vs waitlist control) to assess feasibility (recruitment, retention, adherence) and acceptability.
The app’s content focuses on psychoeducation and skills in illness perception, coping, mindfulness, and disease acceptance; the waitlist control will receive weekly generic lifestyle emails during the study.
Planned enrollment is 40 adults; primary outcomes are feasibility benchmarks for recruitment (≥30%), retention (≥70% completing modules), and adherence (≥50% activity completion). The record lists the study as interventional and not yet recruiting, with Aim 3 anticipated to start in mid-2027.
This entry is a trial registration (trial-record) summarizing planned methods and feasibility outcomes rather than reporting results.
Keep In Mind
This is a ClinicalTrials.gov registration describing a planned pilot trial and formative development work; it does not report any study results. The study is listed as not yet recruiting and aims to measure feasibility and acceptability rather than clinical efficacy in this phase.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorMontefiore Medical Center
Trial IDNCT06510296
Study typeInterventional
Trial phaseNA
Enrollment40 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 14, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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