Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Not applicable · Testing Digital Mind Body Intervention mobile application · 1 site · Montefiore Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Digital Mind Body Intervention mobile application (a behavioral program) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Crohn's Disease, Ulcerative Colitis and Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- age ≥ 18 years
- self-identify as Black/African American and/or Hispanic/Latino(a/x)
- diagnosed with Crohn's disease or ulcerative colitis
Plus 2 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2027-07 (planned).
- Main results expected around 2028-09 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- Feasibility - DMBI recruitment rate (8 weeks)
In the researchers’ words
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 distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Diseases |
| Lead sponsor | Montefiore Medical Center |
| Collaborators | National Center for Advancing Translational Sciences (NCATS); Hureka Technologies; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 40 (estimated) |
| Start date | 2027-07 |
| Primary completion (est.) | 2028-09 |
| First posted | 2024-07-19 |
| Last updated | 2026-09-14 |
| Official title | Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06510296 |
Interventions
- Digital Mind Body Intervention mobile application (Behavioral)
A DMBI mobile application with psychoeducation and skill-building in illness perception, coping, mindfulness, and disease acceptance informed by needs/barriers of Black and Hispanic patients with IBD who have elevated psychological distress and GI professionals caring for IBD patients.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean. * Current suicidality, past suicide attempt, or psychiatric hospitalization.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Montefiore Medical Center | The Bronx, New York | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.