Cognitive-behavioural group treatment for a range of functional somatic syndromes: randomised trial.
Andreas Schröder, Emma Rehfeld, Eva Ornbøl...
https://pubmed.ncbi.nlm.nih.gov/22539780Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID05525598
Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders: A Randomized Controlled Trial.
Led by University of Aarhus · Updated on 2025-06-27
166
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new internet-based therapist-assisted treatment program called "One step at a time" for adults aged 18 to 60 with moderate to severe functional somatic disorder (FSD). This randomized controlled trial compares the new program to an active control self-help internet program called "GetStarted." The study aims to see if more patients in the new treatment report improved physical health and satisfaction three months after completing treatment. The experimental treatment includes 11 online modules over 14 weeks, combining psychoeducation, videos, interactive exercises, and therapist support through messaging and three telephone consultations. The control group accesses a shorter, non-guided self-help program with four modules focused on lifestyle improvements over the same period. Both treatments emphasize understanding symptoms and managing behaviors like exercise, sleep, and diet. Participants will complete self-reported health measures before, during, and after treatment, including follow-ups at 3 and 12 months. The study tracks engagement, treatment satisfaction, and physical and mental health using various questionnaires and scales. Therapists are supervised regularly, and patients may discuss their progress with medical doctors at key points. The total involvement spans over a year, allowing researchers to assess long-term effects and safety.
CONDITIONS
Brief Title
Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 60 years
- Diagnosed with moderate to severe functional somatic disorder affecting single/oligo-organ or multiple organ systems
- Symptoms present for more than 6 months
- If older than 25, must have been active in work or education for at least 12 months in the past 2 years
- Access to a computer or tablet with internet connection
- Ability to read, write, and understand Danish fluently
You will not qualify if you...
- Presence of severe untreated somatic or psychiatric disease that may hinder treatment engagement
- Lack of motivation to participate in internet-delivered treatment
- Poor self-reported computer or internet skills
- Lack of informed consent
- Current treatment with opioids or benzodiazepines
- Use of psychoactive medications must be stable
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for diagnostic assessment and eligibility evaluation
Treatment
Duration - 14 weeks
Participants undergo internet-delivered behavioral treatment for functional somatic disorders with either a therapist-assisted program including 11 modules over 14 weeks or a non-guided self-help program with 4 modules over 14 weeks.
Therapist-assisted participants have approximately 2 written communications per week and 3 supportive phone calls; non-guided participants access the program independently
Follow-up
Duration - Up to 48 weeks after treatment
Participants complete self-reported assessments and attend a follow-up consultation with a medical doctor to evaluate health status and discuss further treatment needs.
Assessments at 3 months (26 weeks) and 12 months (62 weeks) after treatment; 1 follow-up consultation at 3 months
Trial Site Locations
Total: 1 location
1
Department of Functional Disorders
Aarhus C, Denmark, Denmark, 8000
Actively Recruiting
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Research Team
T
Thomas T Lamm, MSc
L
Lisbeth Frostholm, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Mindfulness therapy for somatization disorder and functional somatic syndromes: randomized trial with one-year follow-up.
Lone Overby Fjorback, Mikkel Arendt, Eva Ornbøl...
https://pubmed.ncbi.nlm.nih.gov/23272986Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care - CORRIGENDUM.
Heidi Frølund Pedersen, Johanne L Agger, Lisbeth Frostholm...
https://pubmed.ncbi.nlm.nih.gov/30203729"Understand your illness and your needs": Assessment-informed patient education for people with multiple functional somatic syndromes.
H Frølund Pedersen, A Holsting, L Frostholm...
https://pubmed.ncbi.nlm.nih.gov/31023608Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation.
Geoffrey R Norman, Jeff A Sloan, Kathleen W Wyrwich
https://pubmed.ncbi.nlm.nih.gov/12719681