Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial

• Published in: Contemporary clinical trials communications 2023-04, Vol.32, p.101069-101069, Article 101069
• Main Authors: Pedersen, Heidi Frølund, Lamm, Thomas Tandrup, Fink, Per, Ørnbøl, Eva, Frostholm, Lisbeth
• Format: Article
• Language: English
• Subjects: Cognitive behavioural treatment; Functional somatic disorder; Internet-delivered treatment; Randomized controlled trial; Study protocol; Therapist-assisted
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2023.101069

Functional somatic disorders (FSDs) with symptoms from multiple organs, i.e., multi-system type, are common in the general population and may lead to disability and reduced quality of life. Evidence for efficient treatment programs has been established, however, there is a need for making treatments accessible to a larger group of patients. Internet-delivered therapy has become prevalent and has proven as effective as face-to-face therapy, while providing a flexible and easily accessible treatment alternative. The aim of the current study is to compare the efficacy of the therapist-assisted internet-delivered treatment program One step at a time (OneStep) with the internet-delivered self-help program Get started (GetStarted). A total of 166 participants aged 18–60 years diagnosed with multi-system FSD will be assessed and randomized to either 1) OneStep: a 14-week program consisting of 11 treatment modules based on principles from cognitive behavioural therapy or 2) GetStarted consisting of 1 module on psychoeducation. The primary outcome is physical health, assessed by a Short Form Health Survey (SF-36) aggregate score of the subscales vitality, physical functioning, and bodily pain 3 months after end-of-treatment and self-reported improvement assessed by the Clinical Global Improvement Scale. Secondary outcomes include symptom load, depression, anxiety, and illness worry. Process measures include emotional distress, illness perception, illness behaviour, and symptom interference. This study is the first study to test an internet-delivered treatment program for FSD, multi-system type and has the potential to show the importance of making evidence-based internet-delivered treatment for FSD more accessible. •This is the first e-based treatment for severe functional somatic disorders.•Two active conditions, a guided and an unguided treatment program, are compared.•We expect both programs will prove effective in enhancing physical health.•We hypothesize that the guided program will be superior to the unguided in effect.•If effective, e-based treatment can make specialized treatment more accessible.