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Идёт набор NCT05131035

Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk

Без фазы С лечением Psychosis Prodromal Schizophrenia Prodromal Symptoms

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: SCORES (Specific COgnitive Remediation with Support).
Кому может быть актуально
Состояния в реестре: Psychosis, Prodromal Schizophrenia, Prodromal Symptoms. Базовые параметры: 14 лет — 20 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
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Официальное название

Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk in Adolescents at Clinical High Risk for Psychosis

Обзор

This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. This remotely-delivered intervention combining targeted cognitive training exercises and group support was developed to directly impact processing speed, and at the same time, boost motivation and engagement in adolescents at risk for schizophrenia and other psychotic disorders.

Подробное описание

This study evaluates the effectiveness of a cognitive remediation (CR) program plus group coaching and support designed to improve processing speed and, in turn, social functioning and attenuated positive symptoms in individual considered Clinical High Risk for psychosis. The SCORES (Specific COgnitive REmediation with Support) intervention is a novel Cognitive Remediation program combined with group coaching, performance-based rewards, game-like tasks, and educational elements to increase engagement and retention. The study is funded by a R61/R33 award. In the R61 phase, all participants were asked to complete 40 hours of Cognitive Remediation or brain training (4 hours per week/10 weeks) with a mid-point assessment (at 5 weeks) to determine the training dose needed to impact processing speed as measured by the Matrics Cognitive Consensus Battery. The current R33 (Phase 2) will look to replicate the results of the R61 and assess the specificity of the targeted intervention with the addition of a non-speeded cognitive training group..

Вмешательства

  • Поведенческое SCORES (Specific COgnitive Remediation with Support)
    This study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention. In the 2 year, R61 phase, all participants will c

Первичные конечные точки

  • Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB) [Срок оценки: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)]
Вторичные конечные точки (2)
  • Global Functioning: Social (GF:Social) scale (Phase 2/R33 only) [Срок оценки: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)]
  • SIPS/SOPS: Positive Symptoms (Phase 2/R33 only) [Срок оценки: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)]

Критерии участия

Критерии включения

  • Meet Clinical High Risk (CHR) criteria on the Structured Interview for Psychosis Risk Syndromes, defined by the presence of at least one attenuated positive symptom at a moderate to severe level
  • A score representing 0.5 SD below the mean on Animal Naming, Trails A or BACS: Symbol Coding from the MATRICS Consensus Cognitive Battery (MCCB).

Критерии исключения

  • Any DSM 5 Schizophrenia-Spectrum diagnosis
  • Non-English speaking
  • Past or current history of a clinically significant central nervous system disorder (e.g., seizure disorder)
  • Estimated IQ<70
  • Significant head injury
  • Significant substance abuse
  • Significant visual or auditory impairment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Northwell Health- The Zucker Hillside Hospital — Glen Oaks

Идентификаторы

NCT: NCT05131035 · 21-0832, 23-0500 · R61MH123574 · R33MH123574

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗