Clinical trial NCT06510296: Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Official title: Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility - DMBI recruitment rate
timeFrame: 8 weeks
measure: Feasibility - DMBI retention rate
timeFrame: 8 weeks
measure: Feasibility - DMBI adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Illness Perception
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: IBD self-efficacy
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: Disease acceptance
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: Mindfulness
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: GI-specific symptom anxiety (GSA)
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: Resilience
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: Health-related Quality of Life
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: IBD Activity for Crohn's Disease (CD) Patients
timeFrame: Week 0 (Baseline) and at 8 weeks
measure: IBD Activity for Ulcerative Colitis (UC) Patients
timeFrame: Week 0 (Baseline) and at 8 weeks
Other outcomes:
measure: Fecal Calprotectin Concentrations
timeFrame: Week 0 (Baseline) and at 8 weeks
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Ruby Greywoode, MD
role: PRINCIPAL_INVESTIGATOR
References: