Status:
UNKNOWN
The Mind-Body IBD Study: Understanding the Mind-body Connection in IBD
Lead Sponsor:
King's College London
Collaborating Sponsors:
Medical Research Council
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
An aspect of IBD care that is often overlooked is mental health treatment. Common mental health problems, such as anxiety and depression are very common in IBD, with a meta-analysis estimating prevale...
Detailed Description
Participants will be asked to answer online questionnaires at 3 time points, 6 months apart. They will also be asked to do an at-home stool sample test at the first two time points.
Eligibility Criteria
Inclusion
- Self-reported diagnosis of IBD (pseudo-confirmed with participant's self-reported IBD medication or medication history)
- Willing and able to give informed consent and participate in the study
- Aged 18 and over
- Sufficient command of written and spoken English to understand study procedures and documents, and complete self-report questionnaires
- UK resident (GP registered)
- Email address, telephone number and postal address to enable all study procedures
- Experience at least one flare (requiring medical escalation or medication change) within the last two years
Exclusion
- Under 18 years
- Lives outside of the UK
- Insufficient command of English to understand study documents and procedures
- Not able to give informed consent Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) in the last two weeks.
- People with a cancer diagnosis
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06116331
Start Date
April 1 2023
End Date
December 31 2024
Last Update
November 3 2023
Active Locations (1)
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1
King's College London
London, United Kingdom, SE1 9RT