Internet-based treatment for severe functional somatic disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a novel internet-based therapist-assisted treatment program called 'One step at a time' for patients suffering from moderate to severe functional somatic disorders (FSD). The study involves 166 participants who will be randomly assigned to either the experimental treatment or an active control program called 'Get Started'. The primary outcomes will focus on self-reported physical health and treatment satisfaction over a 14-week period. The trial aims to determine if the therapist-guided approach leads to better health outcomes compared to a non-guided treatment.

Why it matters

Who can join: the full rules

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's running

• Department of Functional Disorders
  Aarhus C, Denmark, Denmark Recruiting

Study contacts

• Principal investigator: Lisbeth Frostholm, Ph.D. — Aarhus Universityhospital
• Study coordinator: Thomas T Lamm, MSc
• Email: THLAMM@rm.dk
• Phone: 61147069

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.