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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Montefiore Medical Center
The Bronx, New York, United States
Start Date
July 1, 2026
Primary Completion Date
September 1, 2028
Completion Date
September 1, 2028
Last Updated
August 13, 2025
40
ESTIMATED participants
Digital Mind Body Intervention mobile application
BEHAVIORAL
Lead Sponsor
Montefiore Medical Center
Collaborators
NCT06226883
NCT07271069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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