[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582184":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":34,"collaborators":25,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":25},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Early intervention group","Group starts immediately with the 14-week intervention",[12,13],"Behavioral: Multicomponent psychological intervention","Behavioral: Early start",{"label":15,"type":6,"description":16,"interventionNames":17},"Late intervention group","Group starts with 14-week intervention after 28 weeks",[12,18],"Behavioral: Late start (after 28 weeks)",[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Multicomponent psychological intervention","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.",[9,15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Early start","Patients in the early group immediately start with the multicomponent psychological intervention",[9],{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Late start (after 28 weeks)","Patients in the late intervention group will wait 28 weeks before starting the intervention",[15],{"type":35,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100582184","psychological-intervention-for-fatigue-in-inflammatory-bowel-diseases-100582184",false,"NCT06860009","Psychological Intervention for Fatigue in Inflammatory Bowel Diseases","Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial","PEARL","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. Males and females 18-70 years old.\n3. Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), inflammatory bowel disease type unclassified (IBDU) based on radiology, endoscopy and\u002For histology\n4. Patients with a disease duration of more than one year\n5. Patients with a score of \\\u003C30 on the FACIT Fatigue scale\n6. Patients possessing a smartphone\n7. Patients with an availability to commit to daily behavioural changes\n8. Patients being fluent in Dutch.\n\nExclusion Criteria:\n\n1. Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening\n2. Patients with objective signs of active disease (CRP\\\u003C10mg\u002FL or faecal calprotectin \\\u003C250µg\u002Fg) at screening\n3. Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening\n4. Patients with planned surgery at screening\n5. Patients with an iron (\\\u003C65 µg\u002FdL), vitamin D (\\\u003C11 µg\u002FL), vitamin B12 (\\\u003C197 ng\u002FL) or folic acid (\\\u003C3.9 µg\u002FL) deficiency or malnutrition (weight loss \\>10-15% within six months, BMI \\\u003C18.5 kg\u002Fm², NRS \\>5 or serum albumin \\\u003C30 g\u002FL) at screening\n6. Patients with thyroid dysfunction or hypophosphatemia at screening\n7. Patients with physical injury (according to researcher's interpretation) at screening\n8. Patients with self-reported sleep disturbance or periods of apnoea at screening\n9. Patients with BMI \\>30 kg\u002Fm² at screening\n10. Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening\n11. Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening","ALL","18 Years","70 Years",{"count":48,"type":49},155,"ESTIMATED","INTERVENTIONAL",[52],"NA","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.",[55,56,57],"IBD","Crohn's Diseases","Ulcerative Colitis (UC)",[59,55],"fatigue","NOT_YET_RECRUITING","2025-03-05",{"date":63,"type":64},"2025-03-10","ACTUAL",{"date":66,"type":49},"2025-09-01",{"date":68,"type":49},"2027-10-30",{"name":5,"class":6}]