A Randomized Pilot Trial of ICanChange, a Mobile Health Intervention to Reduce Cannabis Use in Young Adults With Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Retention rates
研究概览
简要总结
The concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Randomized control trials (RCTs) on well-defined samples (limited to psychosis and CUD) are needed to generate evidence on e-health interventions in individuals with psychosis and CUD. As such, an RCT will be conducted to assess the acceptability and feasibility of administering this e-intervention to young people with psychosis who use cannabis. Besides having scarce cannabis interventions adapted for people with psychosis, there are other barriers to addressing problematic cannabis use, such as the challenging and inadequate access to mental health and substance use services by this population. Implementing these and other approaches in the context of a harm reduction intervention or applying other strategies seeking to minimize cannabis-related harms for people who wish to continue using cannabis may be key in helping individuals set realistic goals that are important and relevant to them.
详细描述
This is a multi-site, two-arm, open-label, pilot randomized control trial, involving 100 young adults diagnosed with psychosis and cannabis use disorder (CUD). Participants will be randomly assigned to either:
Arm 1. Early intervention services (EIS): early intervention for psychosis, including standard of care for psychosis and CUD following Canadian guidelines.
Arm 2. iCC + modified EIS (mEIS): The iCC is an application-based intervention that includes psychotherapeutic modules based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). Participants in this arm also receive the same services as in EIS, excluding formal psychotherapeutic interventions for CUD.
Participants will complete assessments at baseline, and at 6, 12, and 24 weeks from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Young adults age 18 to 35 years old
- •Diagnosed with any psychotic disorder, which can include schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, delusional disorder, psychotic disorder not otherwise specified, brief psychotic disorder and substance-induced psychotic disorder.
- •Has been followed at an early psychosis clinic for a minimum of 3 months
- •Diagnosed with a current CUD (any severity), based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
- •Currently using cannabis (used cannabis at least once in the past month)
- •Accepting an intervention for CUD to cease or decrease his/her use
- •Able to provide full informed consent
- •Available for the whole duration of the study/able to comply with study procedures
- •Able to comprehend French or English
排除标准
- •Any medical condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
- •Any disabling, unstable or acute mental condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
- •Any legal/judicial status/issue, pending legal action, or other reasons in the opinion of the study team that might prevent completion of the study
- •Presence of an additional substance use disorder that, in the opinion of the psychiatrist, precludes safe participation in the study (e.g., very unstable or severe substance use disorder)
- •Currently participating in another specific cannabis use-focused intervention (other than those which are part of the intervention and control arms)
结局指标
主要结局
Retention rates
时间窗: Week 12
Proportions of participants retained in the trial (completing all endpoint assessments)
Completion rates
时间窗: Week 12
Number of participants who completed the first section of the intervention and at least one module from section 2 related to achieving their cannabis consumption objectives or with ongoing participation in EIS.
次要结局
- Acceptability (iCC usage data)(Weeks 0-24)
- Participant satisfaction(Weeks 6, 12 & 24)
- Trial parameters(Week -4 to Week 24)
- Cannabis Use((-2-0 (baseline) and Week 6, 12 & 24)