Internet-based treatment for severe functional somatic disorders

Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders: A Randomized Controlled Trial.

This study is testing a new online therapy program to see if it helps people with severe functional somatic disorders feel better compared to a different online program.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 1 site (Aarhus C, Denmark)
• Trial ID: NCT05525598 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of moderate to severe functional somatic disorder lasting more than six months.

Not a fit: Patients with severe comorbid somatic or psychiatric diseases that are not adequately treated may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from severe functional somatic disorders.

How similar studies have performed: Other studies have shown promise with internet-based treatments for similar conditions, indicating potential for success in this approach.

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.

Where this trial is running

Aarhus C, Denmark

• 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

Conditions: Bodily Distress Disorder Moderate, Bodily Distress Disorder Severe, Fibromyalgia, Chronic Fatigue Syndrome, Irritable Bowel Syndrome, Somatization