Understanding the connection between mental health and inflammatory bowel diseases
The Mind-Body IBD Study: Understanding the Bidirectional Relationship Between Depression and Anxiety With Physical Health Outcomes and Inflammation
King's College London · NCT06116331
This study looks at how mental health issues like anxiety and depression affect people with inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis, by having them fill out online surveys and provide stool samples over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06116331 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between mental health issues, such as anxiety and depression, and inflammatory bowel diseases (IBD) like Crohn's disease and ulcerative colitis. Participants will complete online questionnaires at three different time points, spaced six months apart, and provide at-home stool samples during the first two assessments. The study seeks to uncover the mechanisms behind the bidirectional relationship between mental health and IBD, which is often overlooked in patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over who have a self-reported diagnosis of IBD and have experienced at least one flare in the past two years.
Not a fit: Patients under 18, those living outside the UK, or individuals with a cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health treatment strategies for patients with IBD, enhancing their overall quality of life.
How similar studies have performed: While the relationship between mental health and IBD has been acknowledged, this study's specific focus on understanding the mechanisms is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Self-reported diagnosis of IBD (pseudo-confirmed with participant's self-reported IBD medication or medication history) 2. Willing and able to give informed consent and participate in the study 3. Aged 18 and over 4. Sufficient command of written and spoken English to understand study procedures and documents, and complete self-report questionnaires 5. UK resident (GP registered) 6. Email address, telephone number and postal address to enable all study procedures 7. Experience at least one flare (requiring medical escalation or medication change) within the last two years Exclusion Criteria: 1. Under 18 years 2. Lives outside of the UK 3. Insufficient command of English to understand study documents and procedures 4. Not able to give informed consent Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) in the last two weeks. 5. People with a cancer diagnosis
Where this trial is running
London
- King's College London — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Rona Moss-Morris, PhD — King's College London
- Study coordinator: Natasha Seaton, MSc
- Email: natasha.seaton@kcl.ac.uk
- Phone: 0207 188 1189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Crohn Colitis, mental health, depression, anxiety, psychology