Testing the Effects of a Digital Intervention for Cannabis Harm Reduction - The Cann'App Fractional Factorial Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 565
- 试验地点
- 2
- 主要终点
- Frequency of Protective Behavioral Strategies for Marijuana Use as Measured by the PBSM-17 Short Form Scale
研究概览
简要总结
The goal of this clinical trial is to learn if a digital web application can prevent the risks related to cannabis use among adult regular cannabis users who are enrolled in a pilot trial for cannabis sales regulation conducted in Lausanne, Switzerland (i.e., Cann-L study) and have agreed that their data were used in other studies.
The main question it aims to answer is:
Do participants who have access to the intervention modules of the web application raise their use of protective behavioral strategies to lower cannabis-related risks?
Researchers will compare the intervention modules to a control module (i.e., information on cannabis-related risks and harm reduction) to see if the web application works to prevent the risks related to cannabis use. They will also compare intervention modules across each other to see whether one works better than another.
Participants will:
- Create a user account in the web application
- Access the web application using a laptop, tablet or smartphone
- Use the web application as they wish throughout the duration of the study
- Complete the regular Cann-L study questionnaires every six months, which will be used to measure their cannabis use and related risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization will be imbedded within the application, therefore concealment of allocation will be total. Participants will be blind to their experimental condition. Research staff involved in the study will not be informed of participants' group allocation. All study assessments will be done electronically. The generation of the randomization sequence and its programing into the study website will be conducted by the developing team who will not have contacts with participants or any involvement in the study implementation and analyses.
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
- •Eligible participants will be those included in the pilot trial of cannabis sales regulation in Lausanne, Switzerland (Cann-L study).
- •Inclusion criteria in Cann-L study are:
- •being adult (>18 years old),
- •having current cannabis use (i.e., use at least once a month over the last 6 months)
- •living in the city of Lausanne. To enter the study, they complete an entry assessment verifying their age and proof of residence, and confirming that they have current cannabis use.
排除标准
- •Cann-L exclusion criteria comprise:
- •being younger than 18 years old,
- •being pregnant or breastfeeding,
- •having a health condition contraindicating the use of cannabis (e.g., severe psychiatric disorder).
- •The consent to participate in the Cann-L parent trial comprises an option to be contacted to participate in sub-studies, including studies on prevention measures. All participants having accepted to be so contacted will be proposed to participate in the present study.
- •Therefore, additional exclusion criteria for the present study include:
- •not providing informed consent to participate in sub-studies, including studies on prevention measures,
- •not providing informed consent to participate in the present study.
研究组 & 干预措施
Condition 1 - Personalized Feedback + Information
Access to "Personalized Feedback" module (PF, Study Intervention) and "Information" module (Minimal, Control Intervention)
干预措施: Personalized Feedback on Cannabis Protective Behavioral Strategies, Cannabis Use, Cannabis Expenditures, and Cannabis-Related Consequences (PF) (Behavioral)
Condition 1 - Personalized Feedback + Information
Access to "Personalized Feedback" module (PF, Study Intervention) and "Information" module (Minimal, Control Intervention)
干预措施: Information (Behavioral)
Condition 2 - Imagine the future + Information
Access to "Imagine the Future" module (IMAGIN, Study Intervention) and "Information" module (Minimal, Control Intervention)
干预措施: Imagining the Future Using Counterfactual Thinking and Episodic Future Thinking (IMAGIN) (Behavioral)
Condition 2 - Imagine the future + Information
Access to "Imagine the Future" module (IMAGIN, Study Intervention) and "Information" module (Minimal, Control Intervention)
干预措施: Information (Behavioral)
Condition 3 - Substance-Free Activities Session + Information
Access to "Substance-Free Activities Session" module (SFAS, Study Intervention) and "Information" module (Minimal, Control Intervention)
干预措施: Behavioral Economics-Informed Exercises to Increase Motivation to Engage in Substance-Free Activities (SFAS) (Behavioral)
Condition 3 - Substance-Free Activities Session + Information
Access to "Substance-Free Activities Session" module (SFAS, Study Intervention) and "Information" module (Minimal, Control Intervention)
干预措施: Information (Behavioral)
Condition 4 - Full Intervention + Information
Access to the full intervention (PF+IMAGIN+SFAS) and "Information" module (Minimal, Control Intervention)
干预措施: Personalized Feedback on Cannabis Protective Behavioral Strategies, Cannabis Use, Cannabis Expenditures, and Cannabis-Related Consequences (PF) (Behavioral)
Condition 4 - Full Intervention + Information
Access to the full intervention (PF+IMAGIN+SFAS) and "Information" module (Minimal, Control Intervention)
干预措施: Imagining the Future Using Counterfactual Thinking and Episodic Future Thinking (IMAGIN) (Behavioral)
Condition 4 - Full Intervention + Information
Access to the full intervention (PF+IMAGIN+SFAS) and "Information" module (Minimal, Control Intervention)
干预措施: Behavioral Economics-Informed Exercises to Increase Motivation to Engage in Substance-Free Activities (SFAS) (Behavioral)
Condition 4 - Full Intervention + Information
Access to the full intervention (PF+IMAGIN+SFAS) and "Information" module (Minimal, Control Intervention)
干预措施: Information (Behavioral)
Condition 5 - Information only (Control)
Access to "Information" module (Minimal, Control Intervention)
干预措施: Information (Behavioral)
结局指标
主要结局
Frequency of Protective Behavioral Strategies for Marijuana Use as Measured by the PBSM-17 Short Form Scale
时间窗: This outcome will be assessed at 1- and 7-month follow-up.
This outcome will be measured using the Protective Behavioral Strategies for Marijuana Use (PBSM-17) Short Form scale, a self-reported 17-item questionnaire measuring the frequency of PBS for cannabis use on a 6-point Likert scale ranging from 1 (never) to 6 (always).
次要结局
- Cannabis Use Frequency(This outcome will be measured at 1- and 7-month follow-up.)
- Number of Hours High on a Typical Day(This outcome will be measured at 1- and 7-month follow-up.)
研究者
Jacques Gaume
PhD scientist
University of Lausanne Hospitals