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临床试验/NCT04965012
NCT04965012已完成不适用

Testing the Efficacy of an Online Evidence-Based Treatment for Heavy Cannabis Use in Canadian Adults: A Randomized Controlled Trial (RCT)

York University2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2022年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
2
主要终点
Change in Cannabis Use

研究概览

简要总结

Cannabis is a frequently-used psychoactive substance. While the majority of individuals can use cannabis without experiencing problems, a small minority of people develop cannabis problems. Despite the small-to-medium reported effect sizes of cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) treatments for cannabis misuse, many cannabis users do not seek treatment. Online CBT/MET programs have the potential to be cost-effective and accessible, and offer a less stigmatizing option for treatment. These programs may also help capture cannabis users who experience subclinical problems, who are not captured by traditional treatment. Existing treatment programs also need to be adapted to maximize participant retention and increase treatment completion, as many current cannabis use treatment programs have significant drop-out rates. Hence, the goal of the proposed randomized controlled trial (RCT) is to examine the efficacy of an online evidence-based CBT/MET treatment program. Outcomes of a combined CBT/MET treatment program will be compared to a CBT-only treatment program and a waitlist control. This research will provide insight into the novel contribution of MET to online CBT treatment programs for cannabis misuse.

The researchers are hoping to recruit 303 participants for this study from Central and Eastern Canada. Participants will be randomly assigned to one of the treatment groups (i.e., CBT with MET, CBT without MET) or the psychoeducational control group. Individuals in either treatment group will be given 6 weeks to work through 8 online modules. Throughout the modules, participants will identify goals related to cannabis use, learn strategies to cope with cannabis cravings, triggers, and social pressures and learn to prevent relapse. Participants randomly assigned to the control (i.e., psychoeducation) will receive links to websites that provide general psychoeducation about cannabis use and wellbeing. All participants will complete online assessment measures at baseline, end of treatment, and at follow up approximately one month later (i.e., 0 weeks, 6 weeks, 10 weeks) in order to assess the efficacy of the treatment. At the end of the study, individuals in the control group will be given access to the CBT without MET treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Living in Manitoba or Ontario, Canada
  • Reporting moderate difficulties with cannabis as indicated by a score of 8 or more on the Cannabis Use Disorders Identification Test - Revised (CUDIT-R; Adamson et al., 2010)
  • Fluency in English
  • Having weekly Internet access with a device that allows for video connection
  • Self-report at least a 6 out of 10 on a Likert-type scale for motivation to reduce cannabis use (i.e., how important it is to reduce cannabis use)

排除标准

  • Self-reported engagement in other psychological or pharmacological treatments for cannabis use
  • Elevated suicidality, as defined by scoring greater than minimal risk on a screener
  • Current serious psychiatric disorders or history of psychosis, schizophrenia, bipolar disorder
  • Are a woman who is currently pregnant or breastfeeding

结局指标

主要结局

Change in Cannabis Use

时间窗: Participants will be assessed using the DFAQ-CU at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).

The Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU; Cuttler \& Spradlin, 2017) is a self-report inventory of cannabis use that will be used as the primary assessment of cannabis use. The frequency (i.e., number of days per week) and quantity (i.e., grams) of cannabis use subscales will be used. There is mixed evidence as to whether frequency or quantity better predicts cannabis-related severity, thus information on both will be analyzed.

次要结局

  • Depression(Participants will be assessed using the PHQ-9 at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).)
  • Cannabis-Related Problems(Participants will be assessed using the CUDIT-R at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).)
  • Anxiety(Participants will be assessed using the GAD-7 at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).)
  • Quality of Life(Participants will be assessed using the WHOQOL-BREF at three time points (i.e., prior to treatment; T0); immediately following the 6-week treatment (T1), and at follow-up (i.e., 10 weeks from baseline, 4 weeks from end of treatment, T2).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Keough

Assistant Professor

York University

研究点 (2)

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