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

Heidi Frølund Pedersen; Thomas Tandrup Lamm; Per Fink; Eva Ørnbøl; Lisbeth Frostholm

doi:10.1016/j.conctc.2023.101069

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

Contemp Clin Trials Commun. 2023 Jan 18:32:101069. doi: 10.1016/j.conctc.2023.101069. eCollection 2023 Apr.

Authors

Heidi Frølund Pedersen^{1

2}, Thomas Tandrup Lamm¹, Per Fink^{1

2}, Eva Ørnbøl¹, Lisbeth Frostholm^{1

2}

Affiliations

¹ Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
² Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

Abstract

Background: 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).

Methods: 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.

Conclusions: 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.

Keywords: Cognitive behavioural treatment; Functional somatic disorder; Internet-delivered treatment; Randomized controlled trial; Study protocol; Therapist-assisted.