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Идёт набор NCT07417904

BRAVE Program to Improve Safety and Reduce Violence Risk in Early Psychosis

Без фазы С лечением Violence Risk Early Psychosis

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: BRAVE (Behavioral Response Against Violence Engagement), Treatment As Usual (TAU).
Кому может быть актуально
Состояния в реестре: Violence Risk, Early Psychosis. Базовые параметры: 16 лет — 30 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

Young Adults and Violent Behavior During Early Psychosis (Aim 3)

Обзор

This study evaluates the feasibility and acceptability of BRAVE, a manualized cognitive behavioral therapy (CBT)-based intervention designed to address dynamic risk factors for violence among young adults with early psychosis. Using a stepped-wedge randomized design, all participants will receive treatment as usual followed by the BRAVE intervention. The study will also explore changes in violence-related behaviors and treatment engagement over time.

Подробное описание

Young adults in the early phase of psychosis are at elevated risk for violent behavior, yet few behavioral interventions have been developed to address modifiable violence-related mechanisms in this population. BRAVE is a brief, manualized CBT-based intervention adapted for delivery within early intervention services.

In this stepped-wedge cluster randomized trial, all participants will begin in a treatment-as-usual condition and will be randomly and sequentially transitioned to the BRAVE intervention. Participants will receive weekly BRAVE sessions following completion of the treatment-as-usual period and will continue to receive routine clinical care throughout the study. Study assessments will be conducted at regular intervals across treatment-as-usual, intervention, and follow-up periods. Participants will also identify a collateral informant who will complete study assessments at predefined intervals.

The primary objective of this study is to evaluate the feasibility and acceptability of BRAVE. Secondary objectives include examining changes in violence-related behaviors and related clinical and psychosocial outcomes to inform future, fully powered trials.

Вмешательства

  • Поведенческое BRAVE (Behavioral Response Against Violence Engagement)
    BRAVE is a brief, manualized cognitive behavioral therapy (CBT)-based behavioral intervention designed to address modifiable risk factors associated with violence risk among young adults with early psychosis. The intervention is delivered as weekly sessions within early psychosis services and focuses on enhancing treatment engagement, emotional regulation, cognitive flexibility, and behavioral coping strategies related to aggression and violence risk. Participants continue to receive treatment a
  • Другое Treatment As Usual (TAU)
    Treatment as usual consists of routine outpatient clinical care provided by early psychosis services, including psychiatric medication management and psychosocial services, as determined by the treating clinical team. No study-specific intervention is delivered during this condition.

Первичные конечные точки

  • Working Alliance Inventory - Short Revised (WAI-SR) [Срок оценки: Baseline, Week 24]
Вторичные конечные точки (3)
  • Enrollment rate [Срок оценки: Randomization to week 24]
  • Columbia Initial Screen for Violence [Срок оценки: Baseline, Week 24]
  • Retention rate [Срок оценки: From randomization to Week 24]

Критерии участия

Критерии включения

  • Young adults aged 16-30 years
  • Diagnosis of early psychosis
  • Currently receiving outpatient care through an early psychosis clinic
  • Psychiatrically stable and deemed appropriate for participation by a treating clinician
  • Able and willing to provide informed consent

Критерии исключения

  • Unable to provide informed consent
  • Not fluent in English
  • History of antisocial behavior, as assessed at baseline
  • Immediate risk requiring a higher level of care

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 2 центра
  • Howard University Hospital — Washington D.C.
  • Howard University Hospital — Washington D.C.

Идентификаторы

NCT: NCT07417904 · IRB-2025-1976 · K23MH126312

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗