Digital Mind Body Intervention for Inflammatory Bowel Disease
(DMBI Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRuby Greywoode, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Montefiore Medical Center

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for Black and Hispanic individuals living with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. It aims to help those who may experience psychological distress due to their condition, especially if they face barriers like healthcare access or mental health stigma.

Inclusion Criteria

I am 18 years old or older.

Ability to provide informed consent in English

Self-identify as Black/African American and/or Hispanic/Latino(a/x)

+2 more

Exclusion Criteria

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

I have not had any recent suicidal thoughts, attempts, or psychiatric hospitalizations.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Patient focus groups and semi-structured interviews are conducted to assess needs and barriers for DMBI acceptance and use. A functional DMBI app is developed and evaluated through iterative patient user testing.

Not specified

Pilot Study

An 8-week pilot of the refined DMBI intervention is conducted to assess feasibility and acceptability among Black and Hispanic patients with IBD.

8 weeks

Weekly interactions via the mobile app

Follow-up

Participants are monitored for safety and effectiveness after the pilot study.

4 weeks

Participant Groups

The study tests a Digital Mind Body Intervention (DMBI) mobile app designed to manage the psychological aspects of IBD. The intervention focuses on mindfulness and coping strategies that could improve patients' quality of life by addressing the gut-brain interaction.

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital Mind Body InterventionExperimental Treatment1 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 II: Waitlist ControlActive Control1 Intervention

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