NCT05525598Recruiting
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.
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 24 Aug 2022
- Start date
- 24 Aug 2022
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05525598
What you commit to
- Study type: Interventional
- Planned participants: 166
- From 24 Aug 2022 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient's use of psychoactive medications should be stable.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Functional Disorders Coordinator of this site? Confirm its status | Aarhus C | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.