Psychological Intervention for Fatigue in Inflammatory Bowel Diseases

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a special psychological treatment can help reduce fatigue in people with inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis. The treatment combines Acceptance and Commitment Therapy, which helps people manage their thoughts and feelings, with practical strategies like taking short naps and gradually increasing physical activity. Researchers want to see not only if this helps with fatigue but also how it affects other areas like anxiety, stress, and overall health.

To participate in this trial, you need to be between 18 and 70 years old, have been diagnosed with IBD for more than a year, and have a certain level of fatigue. You should also be able to use a smartphone and be willing to make daily lifestyle changes. The study is currently not recruiting participants, but if you meet the eligibility criteria, it could be a good opportunity to explore how psychological support might improve your well-being. Participants can expect to engage in both therapy sessions and practical activities aimed at managing fatigue while being closely monitored by researchers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• • 2. Males and females 18-70 years old.
• • 3. Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), inflammatory bowel disease type unclassified (IBDU) based on radiology, endoscopy and/or histology
• • 4. Patients with a disease duration of more than one year
• • 5. Patients with a score of \<30 on the FACIT Fatigue scale
• • 6. Patients possessing a smartphone
• • 7. Patients with an availability to commit to daily behavioural changes
• • 8. Patients being fluent in Dutch.
• Exclusion Criteria:
• • 1. Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening
• • 2. Patients with objective signs of active disease (CRP\<10mg/L or faecal calprotectin \<250µg/g) at screening
• • 3. Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening
• • 4. Patients with planned surgery at screening
• • 5. Patients with an iron (\<65 µg/dL), vitamin D (\<11 µg/L), vitamin B12 (\<197 ng/L) or folic acid (\<3.9 µg/L) deficiency or malnutrition (weight loss \>10-15% within six months, BMI \<18.5 kg/m², NRS \>5 or serum albumin \<30 g/L) at screening
• • 6. Patients with thyroid dysfunction or hypophosphatemia at screening
• • 7. Patients with physical injury (according to researcher's interpretation) at screening
• • 8. Patients with self-reported sleep disturbance or periods of apnoea at screening
• • 9. Patients with BMI \>30 kg/m² at screening
• • 10. Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening
• • 11. Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening