Somatic Symptom DisorderROMANCT04044469
Reappraisal Of Medical Assurance (ROMA): An Experimental Study in Patients With Functional Somatic Symptoms
A study testing Immunization-enhancement and Immunization-inhibition in people with Somatic Symptom Disorder, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Somatic Symptom Disorder
- What is being tested?
- Immunization-enhancement and Immunization-inhibition
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 23 Oct 2019to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of a somatoform disorder (F45.x) (as assessed with the SKID interview)
- Age between 18 and 69
- Sufficient German language skills
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Koblenz-Landau
Landau, Rhineland-Palatinate, 76829
About this study
Official title: Why Medical Reassurance Fails in Patients With Functional Somatic Symptoms - An Experimental Study on Cognitive Immunization
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.
Read the 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
- Being tested
- Immunization-enhancement, Immunization-inhibition, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunization-enhancementBehavioural
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-inhibitionBehavioural
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 groupBehavioural
This group receives no further information after watching the videotaped doctor's report.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Immunization-inhibition |
| Control group | Experimental | This group does not receive additional information after the doctor's report. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 minutes after the doctor's report
Secondary outcomes (1)
Cognitive immunization against medical reassurance scale
Assessment of cognitive reappraisal of medical reassurance; each item is scored 1-7 (1 = totally disagree; 7 = totally agree)
Measured: 5 minutes after the doctor's report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start23 Oct 2019
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatic Symptom DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kaiserslautern-Landau, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Tobias Kube, PhD, Principal investigator, University of Kaiserslautern-Landau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044469
- Sponsor's protocol ID
- ROMA_199
- Acronym
- ROMA
- Status last verified
- Jan 2022
- First submitted
- 16 Jul 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36548078
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Medical Reassurance Fails in Patients With Functional Somatic Symptoms - An Experimental Study on Cognitive Immunization
- ClinicalTrials.gov ID
- NCT04044469
- Acronym / sponsor ID
- ROMA / ROMA_199
- Conditions
- Somatic Symptom Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- University of Kaiserslautern-Landau, Harvard Medical School (HMS and HSDM)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Immunization-enhancement | Experimental | Behavioral: Immunization-enhancementThis 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. |
| Immunization-inhibition | Experimental | Behavioral: Immunization-inhibitionThe 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. |
| Control group | Experimental | Behavioral: Control groupThis group does not receive additional information after the doctor's report. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of a somatoform disorder (F45.x) (as assessed with the SKID interview)
- Age between 18 and 69
- Sufficient German language skills
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunization-enhancementThis 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. | Behavioural | Immunization-enhancement |
| Immunization-inhibitionThis 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. | Behavioural | Immunization-inhibition |
| Control groupThis group receives no further information after watching the videotaped doctor's report. | Behavioural | Control group |
Primary outcome
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)
1 secondary outcome
Cognitive immunization against medical reassurance scale
Time frame: 5 minutes after the doctor's report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 36548078Kube 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Kube, PhD principal investigator
University of Kaiserslautern-Landau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunization-enhancement and Immunization-inhibition in people with Somatic Symptom Disorder, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likelihood of a serious disease scale (time frame: 2 minutes after the doctor's report). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.