Reappraisal Of Medical Assurance (ROMA): An Experimental Study in Patients With Functional Somatic Symptoms
Condition: Somatic Symptom Disorder
MeSH terms: Medically Unexplained Symptoms
Study type: Interventional

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.
    

Intervention name(s): Immunization-enhancement; Immunization-inhibition; Control group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; This group receives no further information after watching the videotaped doctor's report.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
Masking: Single (Participant)
Primary purpose: Basic Science