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

NCT05525598 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Bodily Distress Disorder Moderate
  • Bodily Distress Disorder Severe
  • Fibromyalgia
  • Chronic Fatigue Syndrome
  • Irritable Bowel Syndrome
  • Somatization

Interventions

BEHAVIORAL

"One step at a time"

\[see 'arms' section for full description\]

BEHAVIORAL

"Get started"

\[see 'arms' section for full description\]

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Sygehus Lillebaelt

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lisbeth Frostholm, Ph.D. · Aarhus Universityhospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2026-04-30
Completion
2026-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525598 on ClinicalTrials.gov