Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04044469 |
| Other study ID # |
ROMA_199 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2019 |
| Est. completion date |
December 23, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Philipps University Marburg Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
