Trial · NCT05525598
Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
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
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Study type
- Interventional
- Phase
- No phase
- Enrollment
- 166 participants (planned)
- Start
- Aug 24, 2022
- Primary completion
- Apr 30, 2026
- Conditions
- Bodily Distress Disorder Moderate, Bodily Distress Disorder Severe, Fibromyalgia, Chronic Fatigue Syndrome, Irritable Bowel Syndrome, Somatization
Summary
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.
Interventions
- "One step at a time" Behavioral
- "Get started" Behavioral
Locations
1 country: Denmark.
| Facility | City | Country |
|---|---|---|
| Department of Functional Disorders | Aarhus C, Denmark | Denmark |
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Listing only. Eligibility is decided by the study team. TreatIBS is not involved in recruitment.