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

NCT04044469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-10

No results posted yet for this study

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.

Conditions

  • Somatic Symptom Disorder

Interventions

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.

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.

BEHAVIORAL

Control group

This group receives no further information after watching the videotaped doctor's report.

Sponsors & Collaborators

  • University of Kaiserslautern-Landau

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Tobias Kube, PhD · University of Kaiserslautern-Landau

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044469 on ClinicalTrials.gov