Internet-based therapist-assisted treatment for severe functional somatic disorders
Tests an online therapist-assisted program in adults with moderate to severe functional somatic disorder.
Plain-language title generated from the registry record
Registry title: Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
Key facts
- Where
- Aarhus C, DenmarkSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 60 with moderate to severe functional somatic disorder (bodily distress disorder) lasting more than 6 months. It tests a 14-week internet-based treatment.
- Age
- 18 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Moderate to severe bodily distress disorder (BDS). Either 2 organ systems each affected by 3 or more symptoms, or 3 or 4 organ systems each affected by 3 or more symptoms. Symptoms last more than 6 months.
- Earlier treatment
- No ongoing treatment with opioids or benzodiazepines. Any psychoactive medicines must be stable.
Main reasons for not taking part
- Severe other physical or mental illness that is not well treated and could get in the way of the treatment
- Lack of motivation for internet-delivered treatment
- Poor self-reported IT skills
- Ongoing treatment with opioids or benzodiazepines
- No informed consent
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05525598, who can take part
Where in Denmark
- Department of Functional DisordersAarhus C, DenmarkContact: Lisbeth Frostholm, MSc, Ph.dTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Aarhus
- Trial code
- NCT05525598
- Record updated
- 27 June 2025
- Original description
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).Read full original descriptionShow less
Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders: A Randomized Controlled Trial.
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.
Inclusion: 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: Patient's use of psychoactive medications should be stable; 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.