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Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders

RecruitingNAAges 18 Years - 60 YearsAllUniversity of Aarhus
NCT05525598 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). The 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/oligo-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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients must fulfil the criteria for moderate-severe FSD operationalized as being diagnosed with either single/oligo-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. * Patients must have symptom duration \> 6 months. * 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. * Patient must have access to a computer or tablet with internet connection. * Patient must be able to understand, read, and write Danish fluently. Exclusion Criteria: * 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. * Patients are excluded if they lack motivation to engage in internet-delivered treatment. * Patients are excluded if they have poor self-reported IT skills. * Patients are excluded if they lack informed consent. * Patients are excluded if they have ongoing treatments with opioids and benzodiazepines. * Patient's use of psychoactive medications should be stable.
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What it tests

  • "One step at a time"
  • "Get started"
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Where

1 site
Department of Functional Disorders
Aarhus C, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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