- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07588282
The Effect of Psychoeducational Diagnosis Communication on Perception of Illness, Satisfaction, and Behavioral Intentions Among Patients With Functional Neurological Movement Disorders
The Effect of Psychoeducational Diagnosis Communication on Perception of Illness, Satisfaction, and Behavioral Intentions in Patients With Functional Neurological Movement Disorders: An Intervention Study Using a Within-Subject Design
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Functional neurological disorders (FNDs) are common neurological conditions associated with a significant reduction in quality of life and a poor prognosis if diagnosis is delayed. FNDs have multifactorial causes, including psychological stressors, psychiatric comorbidities, and past trauma. A characteristic feature of FNDs is their susceptibility to influence by attention: symptoms can be intensified by increased focus and alleviated by distraction. Despite the establishment of positive diagnostic criteria that position FNS as disorders to be actively diagnosed rather than merely excluded, communicating this in clinical practice remains a challenge. There is often a lack of clear, empathetic, and patient-centered communication of the diagnosis by physicians. Previous studies have shown that the way in which a diagnosis of functional disorders is communicated can have a decisive influence on understanding of the condition, acceptance of the diagnosis, willingness to undergo treatment, and long-term outcomes. In particular, psychoeducational intervention studies show positive effects; however, these have so far been investigated primarily within the context of complex group programs, which are potentially biased by participant self-selection. It remains unclear whether structured, empathetic, and guideline-based individual counseling provided during a regular doctor-patient consultation can achieve similar positive effects. In addition, many physicians report feeling uncertain about how to interact with patients with unexplained symptoms, which can negatively impact the quality of physician- patient communication and the physician-patient relationship. Patients are often simply told which other diseases have been ruled out, without receiving a comprehensible explanation for their symptoms-which can encourage repeated visits to other doctors ("doctor shopping"). Despite the recommendation for patient-centered, understandable, and empathetic explanation of the FNS diagnosis as the first step in treatment, there has been a lack of systematic research to date on the specific effectiveness of this explanation in the doctor-patient conversation. Against this backdrop, the planned study aims to investigate the impact of an empathetic, psychoeducational explanation of the diagnosis on patients newly diagnosed with a functional movement disorder (FMD). The focus is on changes in the perception of the condition and in symptom severity and burden, as well as confidence in the diagnosis of the functional movement disorder, the patients' communication experience and satisfaction with the physician who conveys the diagnosis, intentions regarding "doctor shopping," as well as remaining unanswered questions, individual preferences, and support needs following the diagnosis.
In addition, the self-efficacy of physicians in communicating the diagnosis will be assessed to identify potential correlations with patients' confidence in the diagnosis and the positive effect of the intervention on other variables.
As part of the study, magnetic resonance imaging (MRI) will also be used once as a supplementary imaging modality to assess anatomical and functional aspects of the brain and to make comparisons between participants who show improvements in symptoms and quality of life over the course of the study and those who do not, as well as with healthy control groups.
Study Design: The study follows a prospective intervention design with repeated measurements at four time points within the same participants (within-subject waitlist design). Following an initial baseline assessment (T0), all participants undergo a four-week waiting period without intervention, which serves as an intra-individual control condition.
The measurement time points following the baseline assessment (T0) occur before the diagnosis is made (T1), immediately afterward (T2), four weeks later (T3), and three months later (T4). A separate control group of individuals who do not receive an intervention is not included.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Maria Schneller
- Telefoonnummer: 004331638580395
- E-mail: maria.schneller@medunigraz.at
Studie Locaties
-
-
-
Graz, Oostenrijk, 8036
- Werving
- Medical University of Graz
-
Contact:
- Maria Schneller, Master of Science
- Telefoonnummer: 0043/316/385/833 79
- E-mail: maria.schneller@medunigraz.at
-
Contact:
- Petra Schwingenschuh, Professor
- Telefoonnummer: 004331638583379
- E-mail: petra.schwingenschuh@medunigraz.at
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Presence of any of the following functional movement disorders:
- Functional paralysis
- Functional seizures
- Functional tremor
- Functional drop attacks
- Functional dystonia
- Functional twitching
- Functional facial symptoms
- Functional tics
- Functional parkinsonism
Exclusion Criteria:
- The patient is unable to give informed consent.
- The patient is temporarily unable to give informed consent.
- The patient does not have sufficiently understand German language to answer the questionnaires (the questionnaires are available only in German).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Standardized FND Psychoeducation Guideline
|
The intervention is a structured communication protocol used by physicians to provide a systematic, evidence-based explanation of the diagnosis to patients with Functional Movement Disorders (FMD).
The primary goal is to foster a common understanding of the condition, validate the patient's experience, and establish a foundation for active rehabilitation.
The psychoeducational session follows a 14-step framework designed to address the clinical, neurological, and psychological dimensions of the disorder
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Illness Perception
Tijdsspanne: 4 months (at each measurement point)
|
Revised Illness Perception Questionnaire (IPQ-R), Range (min, max scores) varies by subscale (typically 1-5 per item), Higher scores indicate more negative perceptions.
|
4 months (at each measurement point)
|
|
Trust in the diagnosis
Tijdsspanne: From immediately post-intervention to the last follow up
|
3 questions whether participants trust the diagnosis
|
From immediately post-intervention to the last follow up
|
|
Doctor shopping intentions
Tijdsspanne: From post-intervention to the last follow up
|
Question on whether participants intent to consult other physicians regarding their diagnosis in the future
|
From post-intervention to the last follow up
|
|
Symptom Burden of functional movement disorders
Tijdsspanne: at baseline and the pre-intervention
|
Symptom-Functional Movement Disorder Rating Scale (S-FMDRS), Range: 0 - 60; higher scores mean greater symptom burden and severity
|
at baseline and the pre-intervention
|
|
Patient Global Impression of Severity / Change (PGI-S/C)
Tijdsspanne: At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)
|
standardized instrument to assess the subjective impression of disease severity and change with 3 items, rated on a likert scale from 1-5.
Range of the full scale: 3-15 (higher values indicate higher severity of the disease)
|
At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)
|
|
Clinician Global Impression of Severity / Change (CGI-S/C)
Tijdsspanne: At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)
|
standardized instrument for clinicians to assess the clinicians' impression of disease severity and change of the patient, with 3 items, rated on a likert scale from 1-5.
Range of the full scale: 3-15 (higher values indicate higher severity of the disease)
|
At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Functional comorbidities
Tijdsspanne: at baseline
|
measured with selected subscales of the PHQ-D , which is the German translation and validation of the "Patient Health Questionnaire (PHQ)" by Löwe et al., 1999.
Higher values indicate higher scores indicate more severe symptoms of depression, anxiety, or somatization.
Scores range from 0-3 per item.
|
at baseline
|
|
Patient-reported outcome measures of functional neurological disorders
Tijdsspanne: at baseline, pre-intervention, 1st and 2nd follow up
|
PROM questionnaire by Michaelis et al. (2026) assessing the extent and the impact of the movement disorder on the patient.
Self-reported measurement.
Range: 16 to 80 with higher values indicating higher severity/impairment.
|
at baseline, pre-intervention, 1st and 2nd follow up
|
|
health-related quality of life
Tijdsspanne: baseline, pre-intervention and at the 1st follow up
|
Assessed with the Short Form 36 Health Survey (SF36), a questionnaire of the patient's subjective quality of life, measured with 36 items rated on a likert scale, range of the total score goes from 0 to 100 with higher values indicating better health-related quality of life and function.
|
baseline, pre-intervention and at the 1st follow up
|
|
Remaining questions
Tijdsspanne: immediately after the intervention and at the first follow up
|
assessing remaining open questions with regards to the FND diagnosis after the psychoeducation and diagnosis explanation , asked by the study team
|
immediately after the intervention and at the first follow up
|
|
Patient preferences
Tijdsspanne: immediately after the intervention and at the first follow up
|
Assessing patients treatment preferences, practical, social and systematic support preferences with regards to the FND diagnosis asked through open questions by the study team
|
immediately after the intervention and at the first follow up
|
|
Communication quality
Tijdsspanne: immediately post-intervention.
|
Assess the patient's rating of the communication quality with the clinician, assessed with the standardized EORTC-QLQ-COMU26-questionnaire (translated and validated german version) Range: 0-100, high score indicates good communication.
|
immediately post-intervention.
|
|
Substance Addiction
Tijdsspanne: at baseline
|
WHO - ASSIST V3.0 (Alcohol, Smoking & Substance Involvement Screening Test), scores are evaluated for each substance separetely with higher values indicating higher risk for addiction.
Range from 0 to 27+ for high risk level.
|
at baseline
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1392/2025
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .