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Идёт набор NCT05293834

Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients

Без фазы С лечением Forensic Psychiatry

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: Virtual Reality Aggression Prevention Training (VRAPT).
Кому может быть актуально
Состояния в реестре: Forensic Psychiatry. Базовые параметры: от 12 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients

Обзор

Violent and aggressive behavior as well as disorders related to aggressive behavior are highly common in both adult and juvenile forensic psychiatric patients, and is also present in a subgroup of non-forensic psychiatric in- and out-patients. One promising new treatment option is Virtual Reality. A newly developed program in this area is the Virtual Reality Aggression Prevention Training (VRAPT). The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss forensic and non-forensic psychiatric setting, including both adult and juvenile patients, and to examine whether VRAPT is an effective treatment method for aggressive behavior.

Подробное описание

Violent and aggressive behavior as well as disorders related to aggressive behavior are highly common in both adult and juvenile forensic psychiatric patients, and is also present in a subgroup of non-forensic psychiatric in- and out-patients. In order to minimize the risk for future violent offending it is important to intervene in these high-risk populations. Previous research showed that punishment alone is counterproductive for repeated offending behavior. In contrast, treatment was found to have a positive effect on reoffending (i.e., less reoffending). However, although knowledge about the treatment of (forensic) psychiatric patients has increased significantly in recent decades, it is still not fully understood what works for whom under which circumstances. One promising new treatment option is Virtual Reality. A newly developed program in this area is the Virtual Reality Aggression Prevention Training (VRAPT). This training is currently implemented and examined in correctional and forensic psychiatric facilities in the Netherlands and in Sweden. Results from the first randomized controlled trial (RCT) on the effectiveness of the intervention showed that the VRAPT group showed a decrease in some aggressive behaviors at post-test, but not anymore at 3-month follow-up. The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss forensic and non-forensic psychiatric setting, including both adult and juvenile patients, and to gather information needed for the design of a large, international, high-quality, multicenter RCT. The research questions will address the effect of VRAPT on aggressive behavior, state-trait anger expression, stages of motivational change, emotion regulation, and therapeutic alliance. The present investigation will be the first study to include juvenile forensic psychiatric patients as well as to test VRAPT in Switzerland, thereby increasing the generalizability of the research to other populations. Furthermore, it will be the first time VRAPT will be tested in a non-forensic psychiatric sample exhibiting aggressive behaviour. In addition, it will address problem awareness and therapy motivation as possible factors influencing treatment outcome, and address some of the limitations of previous research.

Вмешательства

  • Поведенческое Virtual Reality Aggression Prevention Training (VRAPT)
    VRAPT consists of sixteen 45- to 60-minute sessions that take place once or twice per week (total duration of the intervention = 8 to 16 weeks). Session time and intensity will be adapted to the individual participant and the sessions will be delivered by specially trained VRAPT therapists in individual settings. The immersive and interactive three-dimensional virtual environment will be presented via headphones and head-mounted displays, using software developed by CleVR. In the virtual environ

Первичные конечные точки

  • Change in Aggression Questionnaire [Срок оценки: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
  • Change in Social Dysfunction and Aggression Scale (SDAS) [Срок оценки: At pre-intervention (t0) and post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
Вторичные конечные точки (6)
  • Change in state-trait anger expression [Срок оценки: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
  • Change in stages of change [Срок оценки: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
  • Change in emotion regulation [Срок оценки: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
  • Assessment of VRAPT experience [Срок оценки: At post-intervention (t1= 8-16 weeks after VRAPT)]
  • Assessment of VRAPT acceptance [Срок оценки: At post-intervention (t1= 8-16 weeks after VRAPT)]
  • Change in therapeutic alliance [Срок оценки: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]

Критерии участия

Критерии включения

  • forensic and non-forensic psychiatric in- and out-patients of the Forensic Department or Adult Department of the Psychiatric University Hospitals Basel with aggressive behavior problems according to their clinical treatment team (which includes senior medical doctor, therapist, nursing staff).

Критерии исключения

  • insufficient German language skills (in speech or reading);
  • intellectual disabilities (IQ < 70);
  • epilepsy;
  • acute psychotic state.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • Psychiatric University Hospitals (UPK) Basel — Basel

Идентификаторы

NCT: NCT05293834 · 2021-02439; pk22Graf

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗