Digital Mind Body Intervention for Inflammatory Bowel Disease
(DMBI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new digital mind-body intervention for individuals with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. The aim is to determine if a mobile app can reduce psychological stress and improve overall well-being, particularly for those experiencing stress and anxiety related to their IBD. Participants will either use the app or join a waitlist group that receives general health tips. The trial is especially suitable for Black, Hispanic, or Latino individuals who experience high stress levels and have IBD. As an unphased trial, it offers a unique opportunity to explore innovative methods for managing stress and enhancing quality of life for those with IBD.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this digital mind-body intervention is safe for people with inflammatory bowel disease?
Research has shown that digital mind-body techniques, such as mindfulness and cognitive-behavioral therapy (CBT), can aid individuals with inflammatory bowel disease (IBD). These methods are particularly beneficial for those with mood or anxiety issues.
The evidence for these digital methods is promising but still limited. Studies have not identified major safety concerns with these treatments. Participants in past studies did not report serious problems, and the treatments are generally well-tolerated.
Yoga-based mind-body techniques have also undergone study. They have reduced anxiety, depression, and stress in people with IBD. These results suggest that mind-body approaches are safe for most individuals.
Overall, digital mind-body techniques appear to be a safe option for managing psychological distress in IBD. However, more research is needed to confirm these findings across different groups.12345Why are researchers excited about this trial?
Researchers are excited about the Digital Mind Body Intervention (DMBI) for inflammatory bowel disease (IBD) because it offers a completely novel approach by harnessing the power of digital technology to manage symptoms. Unlike traditional treatments that often rely on medication to reduce inflammation and immune response, DMBI uses a mobile application to promote mental and physical well-being through mind-body techniques, which could empower patients to manage their condition more actively. This digital approach is particularly appealing as it may minimize side effects associated with medication and provide a more personalized, accessible treatment option for IBD patients.
What evidence suggests that this Digital Mind Body Intervention is effective for inflammatory bowel disease?
Research shows that digital mind-body interventions (DMBIs) can help people with inflammatory bowel disease (IBD). For example, yoga-based programs significantly reduce anxiety, depression, and stress in IBD patients. Another study discovered that mindfulness-based cognitive therapy, which uses mindfulness to change thinking patterns, reduces fatigue in people with IBD. While strong evidence supports these digital approaches for improving mental health, more research is needed to confirm their effectiveness across diverse backgrounds. This trial will evaluate the Digital Mind Body Intervention, which participants may receive, to further explore its potential as a tool for managing both the mental and physical aspects of IBD.12346
Who Is on the Research Team?
Ruby Greywoode, MD
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Follow-up
Participants are monitored for safety and effectiveness after the pilot study.
What Are the Treatments Tested in This Trial?
Interventions
- Digital Mind Body Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator