Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
Recruiting · NCT05525598 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Department of Functional Disorders - Aarhus C, Denmark, Denmark