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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.

Current suicidality, past suicide attempt, or psychiatric hospitalization.

Trial design

Treatments tested in this trial

  • Digital Mind Body Intervention mobile application

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Montefiore Medical Center

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Hureka Technologies

Collaborator