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New treatment option for Bodily Distress Disorder Moderate
Official title Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders
ClinicalTrials.gov ID: NCT05525598
What this study is testing
- What it's testing
- 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.
- Time commitment: about 14 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Patients must fulfil the criteria for moderate-severe FSD operationalized as being diagnosed with either single/oligo-organ BDS, with 2 organ systems...
- 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.
- Patient must be able to understand, read, and write Danish fluently.
You likely can't join if
- Patients are excluded from participation if they present with severe comorbid somatic or psychiatric disease that is insufficiently treated at the...
- 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.
- Patients are excluded if they have ongoing treatments with opioids and benzodiazepines.
- Patient's use of psychoactive medications should be stable.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus C, Denmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 14 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus C, Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.