Mindfulness intervention for Crohn's disease disability
The Effects of a Mindfulness Based Intervention on IBD Disability
This study tests whether a mindfulness program can help people with Crohn's disease feel better by reducing pain, improving mood, and enhancing sleep quality.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05944068 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a mindfulness-based intervention on various disability dimensions in patients with Crohn's disease, including abdominal pain, emotional well-being, and sleep quality. It is a prospective, randomized-controlled trial where participants are divided into two groups: one receiving immediate intervention and the other starting after a six-month waiting period. The study also aims to assess the impact of the intervention on psychological factors such as depression, anxiety, and perceived control, alongside clinical disease activity markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a confirmed diagnosis of Crohn's disease and access to the internet or a smartphone.
Not a fit: Patients with recent changes in IBD medication, major psychiatric disorders, or those participating in other interventional trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and daily functioning for patients with Crohn's disease.
How similar studies have performed: Previous studies have shown promising results for mindfulness interventions in chronic illness management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. Males and females 18-80 years old. 3. Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology 4. Patients with more than one year of follow-up since diagnosis 5. Patients having internet or smartphone access 6. Patients being fluent in Dutch Exclusion Criteria: 1. Participation in an interventional Trial with an investigational medicinal product (IMP) or device 2. Patients that initiated a new IBD medication (steroids, thiopurines, methotrexate, biologicals or small molecules) in the past three months 3. Patients in whom a major surgery or acute surgery with hospitalization can be expected during the complete study period 4. Patients with a present or past psychiatric disease diagnosis (psychosis, bipolar disease, substance abuse) 5. Patients using psychotropic medication 6. Patients with former experience of mindfulness training
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Marc Ferrante — UZ Leuven
- Study coordinator: Marc Ferrante, MD PhD
- Email: marc.ferrante@uzleuven.be
- Phone: 00321642845
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.