Psychological Intervention for Fatigue in Inflammatory Bowel Diseases
Not applicable · Testing Multicomponent psychological intervention, Early start and Late start (after 28 weeks) · Sites not listed yet · Universitaire Ziekenhuizen KU Leuven
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Multicomponent psychological intervention (a behavioral program), Early start (a behavioral program) and Late start (after 28 weeks) (a behavioral program) as a possible treatment. Condition(s) listed: IBD, Crohn's Diseases and Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 155 participants are expected to take part.
- Start date: 2025-09-01 (planned).
- Main results expected around 2027-09-02 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- FACIT fatigue scale (14 weeks)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | IBD; Crohn's Diseases; Ulcerative Colitis (UC) |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Enrollment | 155 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2027-09-02 |
| First posted | 2025-03-05 |
| Last updated | 2025-03-10 |
| Official title | Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06860009 |
Interventions
- Multicomponent psychological intervention (Behavioral)
The multicomponent intervention starts with 8 sessions of ACT (Acceptance and commitment therapy) once a week. After four weeks, patients start with graded activity and frequent napping. After eight weeks in the intervention period, patients will have consults with an IBD psychologist every two weeks. The intervention period is 14 weeks in total. - Early start (Behavioral)
Patients in the early group immediately start with the multicomponent psychological intervention - Late start (after 28 weeks) (Behavioral)
Patients in the late intervention group will wait 28 weeks before starting the intervention
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.