RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
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: Avatar Intervention, Addiction supportive intervention.
- Кому может быть актуально
- Состояния в реестре: Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder. Базовые параметры: от 18 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 →
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Официальное название
A Randomized Controlled Trial Comparing Avatar Intervention to an Addiction Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
Обзор
The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.
Подробное описание
Psychotic disorders (PD) are characterized by a loss of contact with reality. Cannabis use is one of the key factors leading to psychiatric re-hospitalization in PD. In these populations, cannabis use is also associated with depressive symptoms, medication non-compliance, hostility as well as reduced quality of life. Unfortunately, there is no evidence-based intervention available for the treatment of cannabis use disorder (CUD) in this population. Novel interventions for CUD are thus critically needed. Virtual reality-based therapies are a promising avenue that allow patients to try novel strategies in real time instead of having to learn abstract rules. To fill a clinical need, the investigators have created a distinctive intervention for CUD in patients with PD. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions.
Hence, the primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life. The investigators will also explore whether the greater improvements attributable to the Avatar Intervention persist in time, and perform analyses on sex/gender, motivation to change cannabis habits, psychotic relapses, and THC metabolite levels.
Noteworthily, cannabis-related hospitalizations have been identified as one of the core indicators to measure the success of cannabis legalization. As a result, there is a pressing need to design innovative interventions that could have a significant impact on this costly and prime outcome. As there is no evidence-based therapeutic options for CUD in patients with PD, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.
Вмешательства
- Другое Avatar Intervention
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions. - Другое Addiction supportive intervention
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
Первичные конечные точки
- Change in cannabis use (Timeline Follow-Back) [Срок оценки: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
Вторичные конечные точки (2)
- Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT) [Срок оценки: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
- Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS) [Срок оценки: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
Критерии участия
Критерии включения
- Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ;
- Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).
Критерии исключения
- Current SUD for a substance other than cannabis ;
- Ongoing pharmacological or psychological treatment for CUD ;
- Ongoing detoxification for cannabis withdrawal ;
- Presence of neurological disorders ;
- Presence of a severe and unstable physical illness ;
- Inability to provide consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- Research center of the Institut universitaire en santé mentale de Montréal — Montreal
Идентификаторы
NCT: NCT05704582 · MP-12-2023-3234