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Набор скоро начнётся NCT06869616

CRacking the HEterogeneity of Social Outcome Through Neuropsychophysiological Profiles

Наблюдательное Schizophenia 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: Cognitive Remediation.
Кому может быть актуально
Состояния в реестре: Schizophenia Disorder. Базовые параметры: 18 лет — 65 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

CRHESO aims at overcoming the considerable burden of mental disorders, which affects both psychosocial well-being and societal welfare, through a multidisciplinary and integrated approach to explore and remediate dimensions affecting social outcome.

Подробное описание

Social functioning is fundamental for human adaptation, relationships, and psychological well-being. Schizophrenia, a severe psychiatric disorder, is one of the leading causes of disability worldwide and presents significant challenges in social interactions for those affected, increasing the risk of isolation and marginalization. The CRHESO project aims to analyze the factors influencing social functioning. The main hypothesis is that social functioning depends on various components, including neurocognitive, sociocognitive, and language abilities, along with their electrophysiological markers. CRHESO seeks to characterize neuropsychophysiological profiles (combining neuropsychological and electrophysiological data) to better understand social outcomes in individuals with schizophrenia and in healthy subjects.

The investigators will address the following objectives:

* Primary Objective: Primary Objective: To disentangle social functioning complexity in schizophrenia and healthy controls by characterizing neuropsychophysiological profiles linked to levels of social disruption * Secondary Objective: To improve factors associated with social outcome and explore changes in neuropsychophysiological markers The investigators will enroll 50 schizophrenic patients and 50 healthy controls.

Participants will undergo an initial visit with a specialist psychiatrist who will verify that their conditions meet the criteria required by the study. Then, subjects will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

To test if the factors associated with social dysfunction in schizophrenia can be restored, we will propose to subjects with schizophrenia to participate in a rehabilitative training. Those who choose not to undergo the training will only participate in the cross-sectional study, while 10 patients who decide to participate in the training will undergo cognitive remediation training (Cognitive Remediation), already published and demonstrated to be feasible for patients with schizophrenia.

In the check-up visits (i.e., after the training), the patients enrolled in the treatment group, will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

Вмешательства

  • Другое Cognitive Remediation
    10 patients will undergo a rehabilitative training (Cognitive Remediation), already published and demonstrated to be feasible for patients with schizophrenia. This program includes domain-specific neurocognitive exercises aimed at training specific cognitive areas known to be impaired in schizophrenia. The treatment plan includes 15 45-minutes sessions.

Первичные конечные точки

  • Analysis of the difference in neurocognitive data between patients and controls [Срок оценки: through study completion, an average of 2.5 years]
  • Analysis of the difference in sociocognitive data between patients and controls [Срок оценки: through study completion, an average of 2.5 years]
  • Analysis of the difference in pragmatic data between patients and controls [Срок оценки: through study completion, an average of 2.5 years]
  • Analysis of the difference in language data between patients and controls [Срок оценки: through study completion, an average of 2.5 years]
  • Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording [Срок оценки: through study completion, an average of 2.5 years]
  • Analysis of the impact of neuropsychological and electrophysiological measures on quality of life [Срок оценки: through study completion, an average of 2.5 years]
  • Analysis of the impact of neuropsychological and electrophysiological measures on community Integration [Срок оценки: through study completion, an average of 2.5 years]
  • Analysis of the impact of neuropsychological and electrophysiological measures on social connectedness [Срок оценки: through study completion, an average of 2.5 years]
Вторичные конечные точки (8)
  • Evaluation of psychopathology [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring neurocognitive abilities [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring sociocognitive abilities [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring pragmatic abilities [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring language abilities [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring quality of life [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring Community Integration [Срок оценки: through study completion, an average of 2.5 years]
  • Evaluate the efficacy of a rehabilitative training in restoring Social Connectedness [Срок оценки: through study completion, an average of 2.5 years]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Diagnosis of Schizophrenia according to DSM V criteria
  • Ability to provide informed consent

Критерии исключения

  • Intellectual disability
  • Neurological disorder

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06869616 · CRHESO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗