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Functional Neurological DisorderNCT07588282

The Effect of Psychoeducational Diagnosis Communication on Perception of Illness, Satisfaction, and Behavioral Intentions Among Patients With Functional Neurological Movement Disorders

A study testing Psychoeducational communication guide for first-diagnosis of FND in people with Functional Neurological Disorder and Functional Movement Disorder, run by Medical University of Graz at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Psychoeducational communication guide for first-diagnosis of FND
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteAustria
Study dates
31 Mar 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of any of the following functional movement disorders:
  • Functional paralysis
  • Functional seizures
  • Functional tremor
  • Functional drop attacks
  • Functional dystonia
Show all 10Show fewer
  • Functional twitching
  • Functional facial symptoms
  • Functional tics
  • Functional parkinsonism

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Austria1 site, 1 recruiting
  • Medical University of Graz

    Graz, 8036

    Maria Schneller, Master of Science, 0043/316/385/833 79, maria.schneller@medunigraz.at

    Petra Schwingenschuh, Professor, 004331638583379, petra.schwingenschuh@medunigraz.at

    Recruiting

Other trials in Austria

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Psychoeducational communication guide for first-diagnosis of FND
Medical subject headings
Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychoeducational communication guide for first-diagnosis of FNDBehavioural

    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

Study groups in NCT07588282
Study groupRoleWhat they receive
Standardized FND Psychoeducation GuidelineExperimentalNot described
Receives: Behavioral: Psychoeducational communication guide for first-diagnosis of FND

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months (at each measurement point)

  2. Trust in the diagnosis

    3 questions whether participants trust the diagnosis

    Measured: From immediately post-intervention to the last follow up

  3. Doctor shopping intentions

    Question on whether participants intent to consult other physicians regarding their diagnosis in the future

    Measured: From post-intervention to the last follow up

  4. 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

    Measured: at baseline and the pre-intervention

  5. 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)

    Measured: At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)

  6. 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)

    Measured: At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)

Secondary outcomes (7)
  1. 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.

    Measured: at baseline

  2. 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.

    Measured: at baseline, pre-intervention, 1st and 2nd follow up

  3. 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.

    Measured: baseline, pre-intervention and at the 1st follow up

  4. Remaining questions

    assessing remaining open questions with regards to the FND diagnosis after the psychoeducation and diagnosis explanation , asked by the study team

    Measured: immediately after the intervention and at the first follow up

  5. 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

    Measured: immediately after the intervention and at the first follow up

  6. 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.

    Measured: immediately post-intervention.

  7. 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.

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start31 Mar 2026
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Following an initial baseline assessment (T0), all participants undergo a four-week waiting period without intervention, which serves as an intra-individual control condition.
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588282
Sponsor's protocol ID
1392/2025
Status last verified
May 2026
First submitted
5 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducational communication guide for first-diagnosis of FND in people with Functional Neurological Disorder and Functional Movement Disorder, run by Medical University of Graz at 1 site in Austria.

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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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 Austria. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Schneller (004331638580395, maria.schneller@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Illness Perception (time frame: 4 months (at each measurement point)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 May 2026.

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