Reappraisal Of Medical Assurance (ROMA): An Experimental Study in Patients With Medically Unexplained Symptoms (ROMA)
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|ClinicalTrials.gov Identifier: NCT04044469|
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Somatic Symptom Disorder||Behavioral: Immunization-enhancement Behavioral: Immunization-inhibition Behavioral: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study|
|Masking Description:||The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.|
|Primary Purpose:||Basic Science|
|Official Title:||Why Medical Reassurance Fails in Patients With Somatic Symptoms - An Experimental Study on Cognitive Immunization|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||April 30, 2021|
This group receives an immunization-promoting manipulation aimed at triggering negative appraisals of the medical information received and questioning the validity of the medical reassurance. For this purpose, a standardized information text is presented to the participants after receipt of the doctor's report, in which it is stated that the standard medical diagnosis in gastroenterology is often not particularly accurate and that serious diseases are from times to times overlooked. As a further factor contributing to the non-detection of diseases, it is mentioned that doctors are often under time pressure and thus do not have sufficient time to ask patients for all important information. It is believed that communicating this information will result in participants continuing to report high probabilities of serious illness despite the previously received findings report.
This group receives a standardized information text, suggesting that medical diagnostics is not very accurate. Reasons for why a serious disease is overlooked are mentioned and discussed.
The aim of the immunization-inhibiting manipulation is to increase the probability that the normal test results obtained will be used to reduce worries about a serious illness. The participants of this group receive - analogous to the immunization-promoting group - a standardized information text which states that the standard medical diagnosis in gastroenterology is very accurate and that the physicians are very often correct in their initial diagnostic assessment, especially with regard to the assessment of a serious organic disease. This is supported by two scientific publications. The aim of this information is to increase the value of the results obtained, so that the participants are more reassured as a result of the inconspicuous test results and use them to correct their health-related concerns.
This group receives a standardized information text, suggesting that medical diagnostics is very accurate and that doctors are very often right in their first initial diagnostic assessments.
Experimental: Control group
This group does not receive additional information after the doctor's report.
Behavioral: Control group
This group receives no further information after watching the videotaped doctor's report.
- Likelihood of a serious disease scale [ Time Frame: 2 minutes after the doctor's report ]Numerical analogue scale to assess the likelihood of having a serious disease (0 = serious disease excluded; 100 = serious disease for sure)
- Cognitive immunization against medical reassurance scale [ Time Frame: 5 minutes after the doctor's report ]Assessment of cognitive reappraisal of medical reassurance; each item is scored 1-7 (1 = totally disagree; 7 = totally agree)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044469
|Contact: Tobias Kube, PhD||+49 firstname.lastname@example.org|
|Contact: Julia Glombiewski, PhD, Profemail@example.com|
|University of Koblenz-Landau||Not yet recruiting|
|Landau, Rheinland-Pfalz, Germany, 76829|
|Contact: Tobias Kube, PhD +49 6341-28035652 firstname.lastname@example.org|
|Contact: Julia Glombiewski, Prof, PhD +49 6341-28035649 email@example.com|
|Principal Investigator:||Tobias Kube, PhD||University of Koblenz-Landau|