Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodi… (NCT04870476) | Clinical Trial Compass
WithdrawnNot Applicable
Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome
Stopped: "During the feasibility study, it came to the research group's attention, that data was collected in an unauthorized manner. Therefore the trial has been terminated.
0Started 2021-09-19
Plain-language summary
This uncontrolled feasibility pilot study explores the acceptability and potential effect of a 14 week, 11-module, therapist-assisted, internet-delivered treatment program, "One step at the time", for patients moderately affected by Bodily Distress Syndrome. The study includes 25 participants aged 18-60 with multiple functional somatic symptoms for a duration of minimum 6 months. The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is a +2.0 points change in patient-rated physical health measured by the SF-36 aggregate score physical health from before to after treatment.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Meet the diagnostic criteria for Bodily distress syndrome (BDS) with 2-3 of 4 symptom clusters
. Moderate impact on daily life (self-reliant at home, can participate in activities outside the home)
. Symptoms lasting for at least 6 months
. 18-60 years at the time of inclusion
. Previous stable educational or occupational attachment until at least 2 years prior to enrollment and expecting to return to occupational or educational activity
. Motivation and time to participate in a psychological treatment program for treatment of BDS
. IT skills and access to internet and computer/tablet
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in physical Health
Timeframe: Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 months)
. Willingness to engage in working with illness perception and behavioral change
Exclusion criteria
. Presence of other physical condition if the symptoms of this condition can not clearly be separated from symptoms of BDS or the condition is unstable/untreated
. Current moderate or severe psychiatric disorder that substantially impacts daily life or demands special, individualized treatment, or clinical suspicion hereof, e.g. treatment-demanding depression or personality disorder
. Current continuous treatment with opioids and drugs with opioid-like properties