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NCT06510296 · ClinicalTrials.gov registry record · NA
Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
A NA study, sponsored by Montefiore Medical Center.
- Not yet
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT06510296 is a NA study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT06510296, a NA study, has not yet begun recruiting, sponsored by Montefiore Medical Center.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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 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
Interventions
- BEHAVIORAL Digital Mind Body Intervention mobile application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2027-07 |
| Est. Completion | 2028-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06510296
The ClinicalTrials.gov registry entry for NCT06510296 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Digital Mind Body Intervention mobile application is the first listed.
NCT06510296 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06510296 about?
NCT06510296 is a clinical study titled "Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease". 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 distr...
What is the current status of trial NCT06510296?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2027-07. Estimated completion is 2028-09.
What interventions are being tested in trial NCT06510296?
The interventions under investigation include: Digital Mind Body Intervention mobile application (BEHAVIORAL).
Who is sponsoring clinical trial NCT06510296?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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