Psychological Intervention for Fatigue in Inflammatory Bowel Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Multicomponent psychological intervention
BehavioralThe 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
BehavioralPatients in the early group immediately start with the multicomponent psychological intervention
Late start (after 28 weeks)
BehavioralPatients in the late intervention group will wait 28 weeks before starting the intervention
Treatment groups
155 Participants
are divided into 2 treatment groupsGroup A: Early intervention groupOther 2 interventions
Group B: Late intervention groupOther 2 interventions
Trial outcomes
Primary outcomes
1
FACIT fatigue scale
The percentage of participants achieving a ≥20% improvement on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (indicating reduced fatigue) between baseline and week 14.
Time frame
14 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: