NCT06860009Not yet recruiting
Psychological Intervention for Fatigue in Inflammatory Bowel Diseases
Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 155 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 2 Sept 2027
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06860009
What you commit to
- Study type: Interventional
- Planned participants: 155
- From 1 Sept 2025 to the primary completion date, 2 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening
- Patients with planned surgery at screening
- Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening
Other illness
- Patients with objective signs of active disease (CRP\<10mg/L or faecal calprotectin \<250µg/g) at screening
- Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening
Lab values
- 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
Other
- Participation in an interventional Study with an investigational medicinal product (IMP) or device 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
- Patients with BMI \>30 kg/m² at screening
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.