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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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