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Идёт набор NCT07177261

Inter-Brain Synchrony in Schizophrenia

Без фазы С лечением Schizophrenia 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: Fast Friends, Small Talk.
Кому может быть актуально
Состояния в реестре: Schizophrenia 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Inter-Brain Synchrony as a Neural Mechanism of Social Connection in Schizophrenia

Обзор

The goal of this clinical trial is to investigate for the first time in people with schizophrenia a neural mechanism that is thought to facilitate the formation of social connections - inter-brain synchrony - in order to improve scientific understanding of the neural mechanisms of social dysfunction in the disorder, and to provide a basis for the development of new and better treatments to improve social functioning and connectedness in the illness. The main questions it aims to answer are: 1. Investigate inter-brain synchrony as a neural mechanism of social connection in schizophrenia 2. Manipulate social closeness and test for effects on inter-brain synchrony across groups The investigators will compare results from people with schizophrenia to a healthy comparison group (controls) who do not have psychotic disorders to see if inter-brain synchrony is greater in controls. Investigators will also compare measures of inter-brain synchrony before and after the social closeness manipulation to see if inter-brain synchrony changes with increasing closeness. Participants will: * Have a clinicial diagnostic interview and be assessed for clinical symptoms * Have an EEG recorded while interacting with another person. Participants will first work with the other person to draw a figure, and then tap fingers together. Participants will then either undergo the experimental manipulation to increase social closeness (called, "fast friends") or undergo the control condition that does not increase social closeness (called "small talk"). Participants will then repeat the drawing and finger tapping assessment. * After completing the experimental or control condition, participants will then repeat the procedure with the other condition that was not yet done. * Be interviewed on the number and quality of social interactions.

Вмешательства

  • Поведенческое Fast Friends
    Participants will interact with another person while both have their EEG recorded. They will ask and answer 12 questions with the other person that become increasingly personal in nature, e.g., "When did you last cry in front of another person? By yourself?"
  • Поведенческое Small Talk
    Participants will interact with another person while both have their EEG recorded. They will ask and answer 12 impersonal questions with the other person , e.g., "Do you prefer digital watches and clocks or the kind with hands? Why?"

Первичные конечные точки

  • Interbrain synchrony [Срок оценки: Interbrain synchrony will be measured immediately before and immediately following the procedure.]
Вторичные конечные точки (2)
  • Social Network Analysis [Срок оценки: Measured at the start of the study only]
  • Behavioral measures of synchrony [Срок оценки: Investigators will measure these during each of the two maniuplations (small talk and fast friends).]

Критерии участия

Критерии включения

  • sufficient English fluency to comprehend procedures
  • clinical group will include individuals with a DSM-5 diagnosis of schizophrenia who are clinically stable (outpatients, with no hospitalizations 3 months prior to enrollment and no medication changes 1 month prior to enrollment)
  • members of the community without a psychotic disorder, schizophrenia-spectrum disorder, or current major mood disorder, nor history of a first-degree relative with a psychotic disorder.

Критерии исключения

  • evidence of IQ < 70 or developmental disability
  • history of significant neurological disease, serious head injury, or significant current substance use (moderate or severe substance use disorder in the last 3 months, positive urine toxicology screen on the day of assessment, or sedatives/anxiolytics taken within 12 hours of the assessment)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of California, Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07177261 · IRB-25-1279 · 1R21MH139044-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗