CompletedNot Applicable

Reappraisal Of Medical Assurance (ROMA): An Experimental Study in Patients With Functional Somatic Symptoms

Germany60 participantsStarted 2019-10-23

Plain-language summary

Research has shown that patients with functional somatic symptoms continue to worry about having a serious disease despite medical reassurance from their doctors. This study aims to investigate whether cognitive immunization is a mechanism that underlies the sustained concern about having serious disease. To this end, the use of cognitive immunization strategies will be experimentally modulated after receipt of medical test results.

Who can participate

Age range

18 Years – 69 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: * Primary diagnosis of a somatoform disorder (F45.x) (as assessed with the SKID interview) * Age between 18 and 69 * Sufficient German language skills Exclusion Criteria: * acute life-threatening disease * diagnosed mental disorder other than the somatoform disorder that is considered the primary diagnosis (people with other comorbid mental disorders are not excluded if the somatoform disorder is the primary diagnosis)

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

Likelihood of a serious disease scale

Timeframe: 2 minutes after the doctor's report

Trial details

NCT IDNCT04044469

SponsorPhilipps University Marburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-23

View on ClinicalTrials.gov More Somatic Symptom Disorder trials