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Reappraisal Of Medical Assurance (ROMA): An Experimental Study in Patients With Medically Unexplained Symptoms (ROMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04044469
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
University of Koblenz-Landau
Harvard Medical School
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief Summary:
Research has shown that patients with medically unexplained 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.

Condition or disease Intervention/treatment Phase
Somatic Symptom Disorder Behavioral: Immunization-enhancement Behavioral: Immunization-inhibition Behavioral: Control group Not Applicable

Detailed Description:
It is known from research on medically unexplained symptoms (MUS) that patients continue to worry about having a serious illness despite receiving medical reassurance and normal medical test results. However, the psychological mechanisms underlying this maintenance of concern are largely unknown. The planned study will therefore apply knowledge from depression research to this question: In the field of depression there is good evidence that people with depressive symptoms maintain negative expectations despite positive experiences to the contrary, and in previous work it was shown that this is due to a cognitive re-appraisal of expectation-disconfirming experiences, referred to as cognitive immunization. The planned study seeks to investigate whether cognitive immunization is also a mechanism underlying sustained concerns about having a serious disease despite medical reassurance in patients with MUS. For this purpose, participants are presented with a vignette in which gastrointestinal complaints are reported; participants are instructed to imagine to suffer from these symptoms and to go a doctor to have their symptoms examined. Subsequently, participants watch a videotaped doctor's report in which a gastroenterologists discusses the results of several medical tests that have been carried out to exclude the possibility of some serious diseases, such as colon cancer. In this report, the doctor states clearly that, based on the test results, a serious disease is very unlikely. Afterwards, participants of some experimental groups receive additional information on the accuracy of medical diagnostics, aimed at differentially varying the appraisal of the medical reassurance received.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
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: Single (Participant)
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

Arm Intervention/treatment
Experimental: Immunization-enhancement
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.
Behavioral: Immunization-enhancement
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.

Experimental: Immunization-inhibition
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.
Behavioral: Immunization-inhibition
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.

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sum score of at least 9 in the Somatic Symptom Scale-8 (SSS-8)
  • Sum score of at least 23 in the Somatic Symptom Disorder - B Criteria Scale (SSD-12)
  • Age between 18 and 69
  • Sufficient German language skills

Exclusion Criteria:

  • acute life-threatening disease
  • diagnosed mental disorder other than Somatic Symptom Disorder that is considered the primary diagnosis (other mental disorders as comorbid disorders are not excluded if the Somatic Symptom Disorder is the primary diagnosis)

Information from the National Library of Medicine

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 identifier (NCT number): NCT04044469

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Contact: Tobias Kube, PhD +49 6341-28035652
Contact: Julia Glombiewski, PhD, Prof

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University of Koblenz-Landau Not yet recruiting
Landau, Rheinland-Pfalz, Germany, 76829
Contact: Tobias Kube, PhD    +49 6341-28035652   
Contact: Julia Glombiewski, Prof, PhD    +49 6341-28035649   
Sponsors and Collaborators
Philipps University Marburg Medical Center
University of Koblenz-Landau
Harvard Medical School
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Principal Investigator: Tobias Kube, PhD University of Koblenz-Landau

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Responsible Party: Philipps University Marburg Medical Center Identifier: NCT04044469     History of Changes
Other Study ID Numbers: ROMA_199
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Medically Unexplained Symptoms
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs