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Идёт набор NCT04610697

Cognitive Remediation in Forensic Mental Health Care

Без фазы С лечением Psychotic Disorders ADHD TBI (Traumatic Brain Injury) Aggression

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, Active Control.
Кому может быть актуально
Состояния в реестре: Psychotic Disorders, ADHD, TBI (Traumatic Brain Injury), Aggression. Базовые параметры: 18 лет — 55 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

Подробное описание

Forensic patients often display deficits in executive functions, namely difficulties in planning, strategic thinking, problem-solving, and inhibiting inappropriate behavior. Such deficits are transdiagnostic and often underlie behavioral incidents, undermine reintegration into the community, and increase recidivism risk. Despite this, forensic programs usually do not include executive function training.

One approach to train executive functions is cognitive remediation, which consists of behavioral exercises engaging cognitive skills, supported by coaching. In various mental health conditions, cognitive remediation has been repeatedly associated with improvements in cognitive, functional, and clinical outcomes, with small-to-moderate effect sizes. Thus, it should be clarified whether this approach can lead to similar improvements in forensic populations.

In the present trial, we will investigate whether 12 hours over 6 weeks of computerised cognitive remediation administered using tele-health can improve executive functions relative to an active control condition in a sample of 30 forensic inpatients (Aim 1). We will further examine the effect of cognitive remediation (vs. active control) on other variables that are critical for forensic rehabilitation, namely oppositional behaviour, functional capacity, and mental health symptoms (Aim 2). Lastly, we will explore whether any effects persist 12 weeks following cognitive remediation (Aim 3).

Cognitive remediation is an evidence-based inexpensive training method that could be integrated into forensic healthcare practice. In the long term, the expected cognitive, functional, and clinical improvements associated with cognitive remediation have the potential to result in shorter hospitalisations and reduced recidivism rates.

Вмешательства

  • Поведенческое Cognitive Remediation
    Cognitive Remediation consists of exercises, preferably supported by coaching, aimed at engaging cognitive skills and, as a result, at improving cognition as well as functional and clinical outcomes.
  • Поведенческое Active Control
    Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.

Первичные конечные точки

  • Executive Function [Срок оценки: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.]
Вторичные конечные точки (3)
  • Oppositional Behavior [Срок оценки: within 12 weeks before and 12 weeks after training.]
  • Functional Capacity [Срок оценки: within 1 week prior and 1 week after training, as well as at a 12-week follow-up.]
  • Mental Health Symptoms [Срок оценки: within 1 week before and 1 week after training, as well as at a 12-week follow-up.]

Критерии участия

Критерии включения

i1. Age 18 - 55; i2. Ability to read and speak in fluent English; i3. Current status as inpatient on the Forensic Treatment Unit.

Критерии исключения

e1. Intellectual disability; e2. TBI with loss of consciousness followed by known severe neurological sequelae requiring hospitalisation and rehabilitation.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • The Royal's Institute of Mental Health Research — Ottawa

Идентификаторы

NCT: NCT04610697 · TheRoyal

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗