Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders

Launched by UNIVERSITY OF AARHUS · Aug 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new online treatment program called "One step at a time," aimed at helping patients with moderate to severe functional somatic disorders (FSD), which can cause various physical symptoms without a clear medical cause. The trial will involve 166 participants aged 18 to 60, and they will be randomly assigned to either the new treatment program or an existing online program called "GetStarted." To be eligible, participants must have been diagnosed with FSD for at least six months and have access to a computer or tablet with the internet.

During the 14-week treatment period, patients will engage in the online program and complete surveys to share their experiences regarding their physical health and satisfaction with the treatment. The researchers will compare the results to see if those using "One step at a time" have better outcomes than those using the control program. It's important to note that participants should be fluent in Danish and not currently dealing with severe untreated mental or physical health issues that could interfere with the treatment. This trial is currently recruiting participants who meet these criteria.

Gender

ALL

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.