Skip to main content
OpenTrials
Completed

NCT Number: NCT04044469

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Koblenz-Landau

Landau, Rhineland-Palatinate, 76829, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immunization-enhancement

Behavioral

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.

Immunization-inhibition

Behavioral

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.

Control Group

Behavioral

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • University of Kaiserslautern-Landau

Registry information

Official study title

Why Medical Reassurance Fails in Patients With Functional Somatic Symptoms - An Experimental Study on Cognitive Immunization

Acronym: ROMA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.