Psychological Intervention for Fatigue in Inflammatory Bowel Diseases (NCT06860009) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Psychological Intervention for Fatigue in Inflammatory Bowel Diseases
155 participantsStarted 2025-09-01
Plain-language summary
The investigators would like to evaluate the effect of a multicomponent psychological treatment on fatigue as a symptom of patients with inflammatory bowel diseases (IBD). The intervention will be a combined program consisting of a psychological intervention (Acceptance and Commitment Therapy) and a behavioral intervention (implementation of frequent short naps and graded increase of physical activity). Next to the hypothesized effect on fatigue, the investigators will also measure the effect on fatigability, IBD related disability, anxiety, depression, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
✓. Males and females 18-70 years old.
✓. 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
✓. Patients with a disease duration of more than one year
✓. Patients with a score of \<30 on the FACIT Fatigue scale
✓. Patients possessing a smartphone
✓. Patients with an availability to commit to daily behavioural changes
✓. Patients being fluent in Dutch.
Exclusion criteria
✕. Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening
✕. Patients with objective signs of active disease (CRP\<10mg/L or faecal calprotectin \<250µg/g) at screening
✕. Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening
✕. Patients with planned surgery at screening
✕. 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
✕. Patients with thyroid dysfunction or hypophosphatemia at screening
✕. Patients with physical injury (according to researcher's interpretation) at screening
✕. Patients with self-reported sleep disturbance or periods of apnoea at screening