NCT04044469

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Somatic Symptom Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-23
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2019-08-05
• Last updated: 2022-01-10

Locations

1 site across 1 country: Germany