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Behavioral Intervention

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

N/A

Waitlist Available

Led By Ruby Greywoode, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Diagnosed with Crohn's disease or ulcerative colitis

Must not have

Current suicidality, past suicide attempt, or psychiatric hospitalization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the relationship between psychological distress and inflammatory bowel disease (IBD). It found that psychological distress can worsen IBD symptoms and vice versa. Patients with both IBD and psychological

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a digital intervention focusing on mind-body techniques, there are no direct physical side effects like you would expect from medication. However, participants might experience emotional discomfort when engaging in self-reflection or confronting stressful thoughts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with Crohn's disease or ulcerative colitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility - DMBI adherence

Feasibility - DMBI recruitment rate

Feasibility - DMBI retention rate

Secondary study objectives

Disease acceptance

GI-specific symptom anxiety (GSA)

Health-related Quality of Life

+6 more

Other study objectives

Fecal Calprotectin Concentrations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 3Eligibility criteria met