NCT05525598 Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
| NCT ID | NCT05525598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Bodily Distress Disorder Moderate |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2022-08-24 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 166 participants in total. It began in 2022-08-24 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Lisbeth Frostholm, Ph.D.
PRINCIPAL INVESTIGATOR
Aarhus Universityhospital
Frequently Asked Questions
Who can join the NCT05525598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Bodily Distress Disorder Moderate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05525598 currently recruiting?
Yes, NCT05525598 is actively recruiting participants. Contact the research team at THLAMM@rm.dk for enrollment information.
Where is the NCT05525598 trial being conducted?
This trial is being conducted at Aarhus C, Denmark.
Who is sponsoring the NCT05525598 clinical trial?
NCT05525598 is sponsored by University of Aarhus. The principal investigator is Lisbeth Frostholm, Ph.D. at Aarhus Universityhospital. The trial plans to enroll 166 participants.