A Study Of MUSE2 Device For Anxiety And Depression In IBD Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 25-010349
About this study
The purpose of this study is to study the feasibility of patients with IBD using a wearable brain sensing device to help them with mindful meditation and in turn reduce anxiety and depression. To assess the association between mindful meditation and QOL in patients with IBD.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
18 yrs and older
Confirmed diagnosis of Inflammatory Bowel Disease by imaging or endoscopy or histopathology
Non hospitalization for IBD in last 3 months
Ability to provide informed consent
Access to a smart phone with ability to complete all aspects of the trial
No contra-indicating co-morbid health condition that can interfere with the proper use of MUSE2 device as determined by the study investigators.
Exclusion Criteria:
Unstable anxiety and depression as determined by clinical investigators
Unstable inflammatory bowel disease: Hospitalization for IBD in last 3 months, Changes in treatment regimen in last 6 weeks, surgical plans
Use of investigational drugs in last 6 weeks
Currently or in last 4 weeks, practicing mindful meditation of any form on a weekly or regular basis
Enrolled in any other clinical or research study which intervenes on patient’s QOL or stress.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Sachin Dave, M.B.B.S., M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available