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

NCT04044469 | Completed

• 1 other identifier: ROMA_199
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Likelihood of a serious disease scale

  Numerical analogue scale to assess the likelihood of having a serious disease (0 = serious disease excluded; 100 = serious disease for sure)

  2 minutes after the doctor's report

Secondary Outcomes (1)

• Cognitive immunization against medical reassurance scale

  5 minutes after the doctor's report

Study Arms (3)

Immunization-enhancement

EXPERIMENTAL

This group receives an immunization-promoting manipulation aimed at triggering negative appraisals of the medical information received and questioning the validity of the medical reassurance. For this purpose, a standardized information text is presented to the participants after receipt of the doctor's report, in which it is stated that the standard medical diagnosis in gastroenterology is often not particularly accurate and that serious diseases are from times to times overlooked. As a further factor contributing to the non-detection of diseases, it is mentioned that doctors are often under time pressure and thus do not have sufficient time to ask patients for all important information. It is believed that communicating this information will result in participants continuing to report high probabilities of serious illness despite the previously received findings report.

Behavioral: Immunization-enhancement

Immunization-inhibition

EXPERIMENTAL

The aim of the immunization-inhibiting manipulation is to increase the probability that the normal test results obtained will be used to reduce worries about a serious illness. The participants of this group receive - analogous to the immunization-promoting group - a standardized information text which states that the standard medical diagnosis in gastroenterology is very accurate and that the physicians are very often correct in their initial diagnostic assessment, especially with regard to the assessment of a serious organic disease. This is supported by two scientific publications. The aim of this information is to increase the value of the results obtained, so that the participants are more reassured as a result of the inconspicuous test results and use them to correct their health-related concerns.

Behavioral: Immunization-inhibition

Control group

EXPERIMENTAL

This group does not receive additional information after the doctor's report.

Behavioral: Control group

Interventions

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-enhancement

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.

Immunization-inhibition

Control group BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of a somatoform disorder (F45.x) (as assessed with the SKID interview)
• Age between 18 and 69
• Sufficient German language skills

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philipps University Marburg: lead
• University of Kaiserslautern-Landau: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

University of Koblenz-Landau

Landau, Rhineland-Palatinate, 76829, Germany

Location

Related Publications (1)

• Kube T, Riecke J, Heider J, Ballou SK, Glombiewski JA, Rief W, Barsky AJ. How the integration of normal medical test results can be improved in patients with somatoform disorders-An experimental study. Health Psychol. 2023 Feb;42(2):103-112. doi: 10.1037/hea0001243. Epub 2022 Dec 22.

  PMID: 36548078 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Tobias Kube, PhD

  University of Kaiserslautern-Landau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The investigator randomly assigns participants to one of the experimental conditions. Participants are not aware which experimental condition they are allocated to.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: August 5, 2019
• Study Start: October 23, 2019
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)