[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bodily-distress-disorder-moderate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bodily-distress-disorder-moderate":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100479639","internet-based-treatment-for-patients-suffering-from-severe-functional-somatic-disorders-100479639",false,"NCT05525598","Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders","Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders: A Randomized Controlled Trial.","OneSTEP","Inclusion Criteria:\n\n* Patients must fulfil the criteria for moderate-severe FSD operationalized as being diagnosed with either single\u002Foligo-organ BDS, with 2 organ systems that are each affected by 3 or more symptoms, or multi-organ BDS, with 3 or 4 organ systems that are each affected by 3 or more symptoms.\n* Patients must have symptom duration \\> 6 months.\n* If older than 25, patients must have been active in the labor market or educational system for at least 12 months during the last 2 years.\n* Patient must have access to a computer or tablet with internet connection.\n* Patient must be able to understand, read, and write Danish fluently.\n\nExclusion Criteria:\n\n* Patients are excluded from participation if they present with severe comorbid somatic or psychiatric disease that is insufficiently treated at the time of assessment and is deemed to constitute a potential barrier for engaging in the treatment.\n* Patients are excluded if they lack motivation to engage in internet-delivered treatment.\n* Patients are excluded if they have poor self-reported IT skills.\n* Patients are excluded if they lack informed consent.\n* Patients are excluded if they have ongoing treatments with opioids and benzodiazepines.\n* Patient's use of psychoactive medications should be stable.","ALL","18 Years","60 Years",{"count":21,"type":22},166,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of this multi-center, two-armed, randomized controlled trial is to assess the effect of a novel internet-based therapist-assisted treatment program \"One step at a time\" designed for the treatment of patients with moderate to severe functional somatic disorder (FSD).\n\nThe trial will enroll 166 patients with FSD who will be randomized (1:1) to either the experimental condition (14 weeks' treatment with \"One step at a time\") or the active control condition (\"GetStarted\"), which is a non-guided internet-based treatment program for patients with FSD. The trial will include patients aged 18-60 years with an established single\u002Foligo-organ or multi-organ FSD diagnosis, with a duration of minimum 6 months. The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I). The trial will be considered effective if a higher proportion of patients in the experimental condition report a clinically significant outcome compared with patients in the active control condition at the 3-month follow-up after treatment.",[28,29,30,31,32,33],"Bodily Distress Disorder Moderate","Bodily Distress Disorder Severe","Fibromyalgia","Chronic Fatigue Syndrome","Irritable Bowel Syndrome","Somatization","RECRUITING","2025-06-23",{"date":37,"type":38},"2025-06-27","ACTUAL",{"date":40,"type":38},"2022-08-24",{"date":42,"type":22},"2026-10-31",{"name":44,"class":45},"University of Aarhus","OTHER"]