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

Primary Purpose

Somatic Symptom Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Immunization-enhancement
Immunization-inhibition
Control group
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Somatic Symptom Disorder

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Koblenz-Landau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Immunization-enhancement

Immunization-inhibition

Control group

Arm Description

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.

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 does not receive additional information after the doctor's report.

Outcomes

Primary Outcome Measures

Likelihood of a serious disease scale
Numerical analogue scale to assess the likelihood of having a serious disease (0 = serious disease excluded; 100 = serious disease for sure)

Secondary Outcome Measures

Cognitive immunization against medical reassurance scale
Assessment of cognitive reappraisal of medical reassurance; each item is scored 1-7 (1 = totally disagree; 7 = totally agree)

Full Information

First Posted
July 16, 2019
Last Updated
January 5, 2022
Sponsor
Philipps University Marburg Medical Center
Collaborators
University of Kaiserslautern-Landau, Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT04044469
Brief Title
Reappraisal Of Medical Assurance (ROMA): An Experimental Study in Patients With Functional Somatic Symptoms
Acronym
ROMA
Official Title
Why Medical Reassurance Fails in Patients With Functional Somatic Symptoms - An Experimental Study on Cognitive Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
University of Kaiserslautern-Landau, Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
It is known from research on functional somatic symptoms 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 sound 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 functional somatic symptoms. 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 family doctor 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. The experimental conditions described above apply only to the sample of patients with functional somatic symptoms (inclusion and exclusion criteria see below). In addition, we will also recruit a clinical (patients with depression, n=30) and healthy control group (n=30). These control groups will not undergo the cognitive immunization manipulation, but will only pass through the basic procedure of the experimental paradigm, that is, the same procedure as the control group from the sample of patients with functional somatic symptoms. These two control groups (healthy and clinical) are recruited to replicate previous findings showing that patients with somatic symptoms report increased probabilities of suffering from a serious disease compared to patients with depression and healthy control participants. Below, we will only present the inclusion and exclusion criteria of the sample with functional somatic symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatic Symptom Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
Masking
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunization-enhancement
Arm Type
Experimental
Arm Description
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.
Arm Title
Immunization-inhibition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
This group does not receive additional information after the doctor's report.
Intervention Type
Behavioral
Intervention Name(s)
Immunization-enhancement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Immunization-inhibition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
This group receives no further information after watching the videotaped doctor's report.
Primary Outcome Measure Information:
Title
Likelihood of a serious disease scale
Description
Numerical analogue scale to assess the likelihood of having a serious disease (0 = serious disease excluded; 100 = serious disease for sure)
Time Frame
2 minutes after the doctor's report
Secondary Outcome Measure Information:
Title
Cognitive immunization against medical reassurance scale
Description
Assessment of cognitive reappraisal of medical reassurance; each item is scored 1-7 (1 = totally disagree; 7 = totally agree)
Time Frame
5 minutes after the doctor's report

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kube, PhD
Organizational Affiliation
University of Kaiserslautern-Landau
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Koblenz-Landau
City
Landau
State/Province
Rheinland-Pfalz
ZIP/Postal Code
76829
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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