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Идёт набор NCT07588282

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

Без фазы С лечением Functional Neurological Disorder Functional Movement Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psychoeducational communication guide for first-diagnosis of FND.
Кому может быть актуально
Состояния в реестре: Functional Neurological Disorder, Functional Movement Disorder. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Illness Perception [Срок оценки: 4 months (at each measurement point)]
  • Trust in the diagnosis [Срок оценки: From immediately post-intervention to the last follow up]
  • Doctor shopping intentions [Срок оценки: From post-intervention to the last follow up]
  • Symptom Burden of functional movement disorders [Срок оценки: at baseline and the pre-intervention]
  • Patient Global Impression of Severity / Change (PGI-S/C) [Срок оценки: 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) [Срок оценки: At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)]
Вторичные конечные точки (7)
  • Functional comorbidities [Срок оценки: at baseline]
  • Patient-reported outcome measures of functional neurological disorders [Срок оценки: at baseline, pre-intervention, 1st and 2nd follow up]
  • health-related quality of life [Срок оценки: baseline, pre-intervention and at the 1st follow up]
  • Remaining questions [Срок оценки: immediately after the intervention and at the first follow up]
  • Patient preferences [Срок оценки: immediately after the intervention and at the first follow up]
  • Communication quality [Срок оценки: immediately post-intervention.]
  • Substance Addiction [Срок оценки: at baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Австрия · 1 центр
  • Medical University of Graz — Graz

Идентификаторы

NCT: NCT07588282 · 1392/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗