An interventional study of Psychoeducational communication guide for first-diagnosis of FND in Functional Neurological Disorder and Functional Movement Disorder, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Supportive care
Functional neurological movement disorders are common conditions that can lead to significant limitations in daily life. They result from a functional disorder in the brain. A clear, understandable, and empathetic explanation of the diagnosis is a crucial first step in treatment. The purpose of this clinical study is to investigate how a clear and detailed explanation of the diagnosis of functional neurological movement disorders affects patients' understanding of their condition and their symptoms The investigators are interested in how well patients understand the diagnosis and the symptoms they experience as the disease progresses, as well as how the conversation between patient and doctor is experienced from both perspectives. In addition, as part of the study, a one-time examination using brain imaging (magnetic resonance imaging) will be conducted to better understand possible differences in brain function.
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.
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's planned enrollment of 35 is close to the median of 38 across 51 interventional studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of any of the following functional movement disorders:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Psychoeducational communication guide for first-diagnosis of FND
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
Illness Perception
Revised Illness Perception Questionnaire (IPQ-R), Range (min, max scores) varies by subscale (typically 1-5 per item), Higher scores indicate more negative perceptions.
Time frame: 4 months (at each measurement point)
Trust in the diagnosis
3 questions whether participants trust the diagnosis
Time frame: From immediately post-intervention to the last follow up
Doctor shopping intentions
Question on whether participants intent to consult other physicians regarding their diagnosis in the future
Time frame: From post-intervention to the last follow up
Symptom Burden of functional movement disorders
Symptom-Functional Movement Disorder Rating Scale (S-FMDRS), Range: 0 - 60; higher scores mean greater symptom burden and severity
Time frame: at baseline and the pre-intervention
Patient Global Impression of Severity / Change (PGI-S/C)
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)
Time frame: 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)
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)
Time frame: At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)
Functional comorbidities
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.
Time frame: at baseline
Patient-reported outcome measures of functional neurological disorders
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.
Time frame: at baseline, pre-intervention, 1st and 2nd follow up
health-related quality of life
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.
Time frame: baseline, pre-intervention and at the 1st follow up
Remaining questions
assessing remaining open questions with regards to the FND diagnosis after the psychoeducation and diagnosis explanation , asked by the study team
Time frame: immediately after the intervention and at the first follow up
Patient preferences
Assessing patients treatment preferences, practical, social and systematic support preferences with regards to the FND diagnosis asked through open questions by the study team
Time frame: immediately after the intervention and at the first follow up
Communication quality
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.
Time frame: immediately post-intervention.
Substance Addiction
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.
Time frame: at baseline
Started Mar 2026 (actual). Primary completion is estimated for Jul 2027, 16 months after the start.
Of 34 interventional studies with no phase under Conversion Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
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