Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease

NCT06510296 | Not Yet Recruiting DMC

• 2 other identifiers: 2024-160641K12TR004411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (3)

• Feasibility - DMBI recruitment rate

  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.

  8 weeks

• Feasibility - DMBI retention rate

  DMBI Retention rate will be determined by the proportion of enrolled patients who complete all DMBI modules. A benchmark to define this feasibility outcome will be ≥ 70% of enrolled patients completing all DMBI modules.

  8 weeks

• Feasibility - DMBI adherence

  DMBI adherence will be assessed by the percentage of completed activities per module will be determined. A benchmark to define this feasibility outcome will be ≥ 50% of completed activities per module.

  8 weeks

Secondary Outcomes (9)

• Illness Perception

  Week 0 (Baseline) and at 8 weeks

• IBD self-efficacy

  Week 0 (Baseline) and at 8 weeks

• Disease acceptance

  Week 0 (Baseline) and at 8 weeks

• Mindfulness

  Week 0 (Baseline) and at 8 weeks

• GI-specific symptom anxiety (GSA)

  Week 0 (Baseline) and at 8 weeks

Other Outcomes (1)

• Fecal Calprotectin Concentrations

  Week 0 (Baseline) and at 8 weeks

Study Arms (2)

Digital Mind Body Intervention

EXPERIMENTAL

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

Behavioral: Digital Mind Body Intervention mobile application

Waitlist Control

NO 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

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.

Digital Mind Body Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.
• Current suicidality, past suicide attempt, or psychiatric hospitalization.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Ruby Greywoode, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruby Greywoode, MD

CONTACT

347-671-8211; rgreywoode@montefiore.org

Shalika Fnu

CONTACT

347-968-4203; fnu.shalika@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)