[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479639":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":68,"id":73,"slug":26,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Internet-delivered therapist-assisted treatment: \"One step at the time\"","EXPERIMENTAL","\"One step at the times\" consists of 11 internet-delivered modules delivered over 14 weeks. Each module explores a different theme, primarily including elements from Cognitive Behavioral Therapy (CBT) for FSD, and includes FSD-related psychoeducation, various interactive exercises, and video and audio material. Interactions between patients and the therapist will take place via the telephone 3 times (start, mid-term, and end-of-treatment) and embedded messaging (therapist will respond to patients) approx. 2 times a week. The participating therapists are supervised every other week by specialized psychologists.",[13],"Behavioral: \"One step at a time\"",{"label":15,"type":16,"description":17,"interventionNames":18},"Internet-delivered non-guided treatment: \"Get started\"","ACTIVE_COMPARATOR","\"Get started\" is a non-guided self-help program, developed as an active control, that includes 4 modules consisting of FSD-related psychoeducation and guidance on making lifestyle improvements. Participants will have access to the \"Get started\" program for 14 weeks.",[19],"Behavioral: \"Get started\"",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","\"One step at a time\"","\\[see 'arms' section for full description\\]",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"\"Get started\"",[15],[31],{"name":32,"affiliation":33,"role":34},"Lisbeth Frostholm, Ph.D.","Aarhus Universityhospital","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Thomas T Lamm, MSc","CONTACT","61147069","+0045","THLAMM@rm.dk",{"name":32,"role":38,"phone":43,"phoneExt":40,"email":44},"22618875","lisbeth.frostholm@aarhus.rm.dk",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Department of Functional Disorders","RECRUITING","Aarhus C","Denmark","8000","DK",{"type":54,"coordinates":55},"Point",[56,57],10.21231,56.16558,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":63},"Lisbeth Frostholm, MSc, Ph.d","+45 22618875","lisbfros@rm.dk",{"name":37,"role":38,"phone":65,"phoneExt":26,"email":41},"+45 22130490",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[69,71],{"name":70,"class":6},"Aarhus University Hospital",{"name":72,"class":6},"Sygehus Lillebaelt","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":84,"type":85},166,"ESTIMATED","INTERVENTIONAL",[88],"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.",[91,92,93,94,95,96],"Bodily Distress Disorder Moderate","Bodily Distress Disorder Severe","Fibromyalgia","Chronic Fatigue Syndrome","Irritable Bowel Syndrome","Somatization","2025-06-23",{"date":99,"type":100},"2025-06-27","ACTUAL",{"date":102,"type":100},"2022-08-24",{"date":104,"type":85},"2026-10-31",{"name":5,"class":6},1]