A Pilot Study : Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Psychotic Disorders and/or Mood Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in cannabis use (Timeline Follow-Back)
研究概览
简要总结
This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or mood disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.
详细描述
Cannabis use disorder (CUD) is a complex issue, even more so when it is comorbid with a psychotic disorder or a mood disorder. Indeed, this population seems more vulnerable to this substance since the incidence of developing CUD is five to six times higher compared to the general population. In these populations, cannabis use is one of the key factors leading to psychiatric re-hospitalization. It is 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 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 concepts. In response to this clinical need, our team has created a distinctive intervention for CUD in patients with psychotic disorders and/or mood disorders. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. This proposal thus aims to conduct a proof-of-concept to assess the efficacity of Avatar Intervention for CUD in patients with psychotic disorders and/or mood disorders. The primary objective of this open trial will be to determine whether cannabis-related outcomes (i.e. frequency and quantity of use) diminish after treatment as well as 3- 6- and 12-months follow-up. As for secondary objectives, the investigator will seek to determine the effect of the intervention on motivation to change, severity of cannabis dependence, psychiatric symptoms (mood and psychotic) and whether quality of life improves after treatment, at 3- 6- and 12-months follow-up. As there is no evidence-based therapeutic options for CUD in patients with psychotic disorders and/or mood disorders, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, bipolar disorder and major depression. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).
排除标准
- •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.
研究组 & 干预措施
Experimental: Avatar Intervention
The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use with the use of virtual reality and avatars.
干预措施: Avatar Intervention (Behavioral)
结局指标
主要结局
Change in cannabis use (Timeline Follow-Back)
时间窗: Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.
次要结局
- Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)(Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up)
- Change in psychiatric symptoms (Positive And Negative Syndrome Scale - PANSS)(Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up)
- Change in quality of life (Quality of Life Scale -QLS)(Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up)
- Motivation to change cannabis use (Marijuana Ladder)(Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up)