The aim of this multi-center, two-armed, randomized controlled trial is to assess the effect of a novel internet-based therapist-assisted treatment program "One step at a time" designed for the treatment of patients with moderate to severe functional somatic disorder (FSD).
The trial will enroll 166 patients with FSD who will be randomized (1:1) to either the experimental condition (14 weeks' treatment with "One step at a time") or the active control condition ("GetStarted"), which is a non-guided internet-based treatment program for patients with FSD. The trial will include patients aged 18-60 years with an established single/oligo-organ or multi-organ FSD diagnosis, with a duration of minimum 6 months. The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I). The trial will be considered effective if a higher proportion of patients in the experimental condition report a clinically significant outcome compared with patients in the active control condition at the 3-month follow-up after treatment.
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.
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.
Parallel
"One step at a time"
Behavioral\[see 'arms' section for full description\]
"Get started"
Behavioral\[see 'arms' section for full description\]
Change in SF-36 physical health (SF-36 PPH scales)
The SF-36 is a self-reported physical, mental, and social health. Analysis of primary outcome will be based on the PPH subscales. The change that is used to test the main hypothesis is the change from baseline (0 weeks) to 3-month follow-up (26 weeks). The full SF-36 is measured at the following time-points: Pre-assessment (-2 weeks), baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks). During During treatment (week 3, 6, 9), only the SF-36 PPH subscales (Bodily pain, physical functioning, vitality) will be measured.
Clinical Global Improvement Scale (CGI)
Single item 5-point self-reported evaluation of overall health improvement. The time point that is used to test the main hypothesis at 3-month follow-up (26 weeks). The CGI is measured on the following time points: After treatment (14 weeks), at 3-month follow up (26 weeks), at 12-month follow up (62 weeks)
The Numeric Rating Scale (NRS)
Self-reported symptom intensity and symptom interference
Emotional distress, anxiety, depression subscales of the 92-item Danish version of the Symptom Checklist (SCL-92)
Self-reported symptoms of anxiety, depression, and emotional distress
The BDS Checklist-25
Self-reported physical symptoms
Whiteley-6 revised
Self-reported illness worries
Automatic log data
The follow variables are logged variables: The follow variables are logged variables: Time spent in program; Modules and pages; Number of logins; Number of completed modules; Activities engaged with (e.g. exercises interacted with); Textual content of all text boxes.
End-of-module evaluation
Self-reported single item questions regarding the experience of working within each module
Assessing medical doctor evaluation
Medical doctor responsible for assessment and inclusion will note to which degree patients live up to inclusion criteria, and make an assessment of clinical characteristics and barriers to treatment.
Therapist evaluation of phone consultations
Date and theme of phone consultations
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Sygehus Lillebaelt
Collaborator
