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

NCT ID: NCT06510296

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2028-09-30

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.

Detailed Description

Prior to conducting the randomized pilot study, as part of Aim 1, patient focus groups will be conducted, based on the IBD social-cognitive model (IBD SCM), with a prototype DMBI to assess resonance and preferences on how to convey and display intervention concepts and components. Semi-structured interviews will be conducted among gastroenterology professionals (GIs) to assess perceived needs and barriers to DMBI acceptance and use in clinical care of Black and Hispanic patients with IBD, and define intervention elements.

Aim 2 will be guided by the needs/barriers identified in Aim 1, a functional DMBI app will be developed. A formative/summative evaluation of the app intervention will be conducted through iterative patient user testing to ensure functionality and usability (e.g. accessibility/ease of use, relevant and non-stigmatizing content).

Aim 3, the basis for this registration, will consist of an 8-week pilot of the refined DMBI intervention, developed in Aim 2 among a separate group of patients, to assess the feasibility and acceptability of DMBI among Black and Hispanic patients with IBD. It is anticipated that Aim 3 will not initiate until July, 2027. Earlier Aims, not represented in this record, are in progress.

Conditions

Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Digital Mind Body 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 Type: EXPERIMENTAL

Digital Mind Body Intervention mobile application

Intervention Type: 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.

Waitlist Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital Mind Body Intervention mobile application

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruby Greywoode, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Central Contacts

Ruby Greywoode, MD

Role: CONTACT

rgreywoode@montefiore.org

347-671-8211

Shalika Fnu

Role: CONTACT

fnu.shalika@einsteinmed.edu

347-968-4203

Facility Contacts

Ruby Greywoode

Role: primary

347-671-8216

Shalika Fnu

Role: backup

347-968-4203

Other Identifiers

1K12TR004411

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-16064

Identifier Type: -

Identifier Source: org_study_id