NCT06510296Not yet recruiting
Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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 has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier. The emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches. Although high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Jul 2024
- Start date
- Jul 2027
- Primary completion date
- Sept 2028
- Lead sponsor
- Montefiore Medical Center
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06510296
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Jul 2027 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current suicidality, past suicide attempt, or psychiatric hospitalization.
Other
- Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.