Randomized Controlled Trial of a Volitional Help Sheet in Cannabis Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Cannabis use reduction (frequency)
研究概览
简要总结
The study will recruit frequent users of cannabis (defined at least fortnightly use) and randomize them either to: (1) form implementation intentions by linking situations in which they are tempted to use cannabis with strategies to avoid using cannabis in those situations by using a volitional help sheet, or (2) to consider the situations in which they are tempted to use cannabis alongside possible strategies to avoid using it as presented in the volitional help sheet but not to form implementation intentions. The effects on self-reported cannabis use will be assessed 1 month post-intervention. Predictors of cannabis reduction will also be examined.
详细描述
Design: This study will use questionnaires to assess participants cannabis habits (frequency and amount of use) and then employ planning strategies to help them quit. Follow up questionnaires will be used to ascertain the success of planning on reduction in cannabis use.
Sample Size: We plan to recruit a minimum of 60 participants in each condition (120 total) but aim to collect data from as many participants as possible.
Recruitment: To participate in this study a person must be over the age of 18 and a frequent user of cannabis. The study will be advertised online on social media platforms.
Procedure: Potential participants will follow an online link to a briefing sheet that provides information about the study. The sheet will also inform participants that they do not have to complete the questionnaire and that they can withdraw from the study at any time without giving a reason. Once they have read the briefing sheet and generated their personal identity code, as instructed, they will complete the questionnaire online. A month after the participants have completed the initial questionnaire they will receive a link to a follow-up questionnaire via email. Email addresses will be stored separately to study data and will be destroyed once the follow up phase has completed and their involvement in the study ends.
Outcomes and Analysis: The main purpose of this study is to explore the role of planning in encouraging people to reduce cannabis use. Quantitative analysis will be conducted to assess the effects of planning on cannabis use reduction. The investigators expect to find that planning is effective in helping people reduce their use.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Frequent cannabis user (at least fortnightly)
排除标准
- •Younger than 18 years of age
- •Infrequent / no cannabis use (less than fortnightly)
研究组 & 干预措施
Control (volitional help sheet)
Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour and are asked to tick critical situations/appropriate responses that might be useful to them.
干预措施: Volitional help sheet (Behavioral)
Intervention (volitional help sheet)
Participants read a brief statement designed to encourage them to reduce their cannabis use ("We want you to plan to reduce your cannabis use"). Participants are presented with a table with two columns and twenty rows. Twenty 'high risk' situations (temptations) are presented in the left hand column and 20 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to use cannabis and identifying ways to overcome those temptations had been shown to help people change their behaviour. Implementation intentions are formed by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.
干预措施: Volitional help sheet (Behavioral)
结局指标
主要结局
Cannabis use reduction (frequency)
时间窗: 1 month
Self-reported cannabis use - frequency of use (days per week)
Cannabis use reduction (amount)
时间窗: 1 month
Self-reported cannabis use -amount of cannabis (weight)
次要结局
- Self reported habit as measured by the automaticity subscale of the Self-Report Habit Index.(1 month)
- Self reported action control as measured by the scale developed by Sniehotta et al (2011)(1 month)
- Self reported craving as measured by items from the mood and physical symptoms scale (MPSS)(1 month)
研究者
Lynsey Gregg
Principal Investigator
University of Manchester