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Behavioral Intervention

Digital Mind Body Intervention for Inflammatory Bowel Disease (DMBI Trial)

N/A
Waitlist Available
Led By Ruby Greywoode, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* age ≥ 18 years
* self-identify as Black/African American and/or Hispanic/Latino(a/x)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

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 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.

Who is the study for?
This trial is for Black and Hispanic individuals living with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. It aims to help those who may experience psychological distress due to their condition, especially if they face barriers like healthcare access or mental health stigma.
What is being tested?
The study tests a Digital Mind Body Intervention (DMBI) mobile app designed to manage the psychological aspects of IBD. The intervention focuses on mindfulness and coping strategies that could improve patients' quality of life by addressing the gut-brain interaction.
What are the potential side effects?
Since this is a digital intervention focusing on mind-body techniques, there are no direct physical side effects like you would expect from medication. However, participants might experience emotional discomfort when engaging in self-reflection or confronting stressful thoughts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility - DMBI adherence
Feasibility - DMBI recruitment rate
Feasibility - DMBI retention rate
Secondary outcome measures
Disease acceptance
GI-specific symptom anxiety (GSA)
Health-related Quality of Life
+6 more
Other outcome measures
Fecal Calprotectin Concentrations

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Digital Mind Body InterventionExperimental Treatment1 Intervention
Participants randomized to the Digital Mind Body mobile intervention will receive a unique user identification (user ID) to access the DMBI mobile application. Randomized in a 2:1 ratio for DMBI intervention vs Waitlist Control
Group II: Waitlist ControlActive Control1 Intervention
Patients randomized to the Waitlist Control arm/group will not receive the DMBI until the end of the study. During the study, to control for expectancy and attention, the Waitlist Control will receive a weekly email with generic tips on a healthy lifestyle in IBD. Randomized in a 2:1 ratio for DMBI intervention vs Waitlist Control

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
455 Previous Clinical Trials
583,375 Total Patients Enrolled
Ruby Greywoode, MDPrincipal InvestigatorMontefiore Medical Center
2 Previous Clinical Trials
455 Total Patients Enrolled
~27 spots leftby Sep 2029