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

Overview

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, virtual 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.

Interventions

• Behavioral 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.

Primary outcome measures

• Feasibility - DMBI recruitment rate [Time frame: 8 weeks]
• Feasibility - DMBI retention rate [Time frame: 8 weeks]
• Feasibility - DMBI adherence [Time frame: 8 weeks]

Secondary outcome measures (9)

• Illness Perception [Time frame: Week 0 (Baseline) and at 8 weeks]
• IBD self-efficacy [Time frame: Week 0 (Baseline) and at 8 weeks]
• Disease acceptance [Time frame: Week 0 (Baseline) and at 8 weeks]
• Mindfulness [Time frame: Week 0 (Baseline) and at 8 weeks]
• GI-specific symptom anxiety (GSA) [Time frame: Week 0 (Baseline) and at 8 weeks]
• Resilience [Time frame: Week 0 (Baseline) and at 8 weeks]
• Health-related Quality of Life [Time frame: Week 0 (Baseline) and at 8 weeks]
• IBD Activity for Crohn's Disease (CD) Patients [Time frame: Week 0 (Baseline) and at 8 weeks]
• IBD Activity for Ulcerative Colitis (UC) Patients [Time frame: Week 0 (Baseline) and at 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Montefiore Medical Center — The Bronx

Identifiers

NCT: NCT06510296 · 2024-16064 · 1K12TR004411

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗