Actively Recruiting
Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
Led by University of Aarhus · Updated on 2025-06-27
166
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with moderate to severe functional somatic disorder affecting one or more organ systems with at least 3 symptoms per affected system
- Symptoms lasting longer than 6 months
- If over 25 years old, having been active in work or education for at least 12 months in the last 2 years
- Access to a computer or tablet with internet connection
- Ability to read, write, and understand Danish fluently
You will not qualify if you...
- Presence of severe untreated somatic or psychiatric disease that prevents participation
- Lack of motivation to engage in internet-based treatment
- Poor self-reported skills using information technology
- Lack of informed consent
- Current treatment with opioids or benzodiazepines
- Use of psychoactive medications must be stable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Functional Disorders
Aarhus C, Denmark, Denmark, 8000
Actively Recruiting
Research Team
T
Thomas T Lamm, MSc
CONTACT
L
Lisbeth Frostholm, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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