Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Clinical Trial NA study, sponsored by Montefiore Medical Center.

NCT06510296 is a NA study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

DMBI recruitment rate will be determined by the proportion of eligible patients who enroll into the trial. A benchmark to define this feasibility outcome will be ≥ 30% of eligible patients enrolling.

Interventions

  • BEHAVIORAL Digital Mind Body Intervention mobile application

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2027-07
Est. Completion 2028-09
Phase NA
Montefiore Medical Center

345 total trials

What is known before NCT06510296 opens enrollment

NCT06510296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Digital Mind Body Intervention mobile application is the first listed.

NCT06510296 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06510296's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01306019 · 40 participants · Phase 1

    Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)

  • NCT01608152 · 40 participants

    Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors

  • NCT01668082 · 40 participants · NA

    An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

  • NCT02015013 · 40 participants · Phase 2

    Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT06510296, the US trial registry maintained by the National Library of Medicine. NCT06510296 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.