Using Assistance From a Health Educator to Increase Effectiveness of an Internet Intervention for Alcohol Problems. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Drinks preceding week
研究概览
简要总结
The purpose of this study is to determine whether an internet intervention for alcohol problems is more effective when delivered with assistance from a health care educator via e-mail during the first two weeks after randomization, as compared to simply providing the intervention without any such assistance.
详细描述
This project aims to study the previously evaluated multi-module internet intervention Alcohol Help Center delivered with assistance from a health educator (AHC+A). The assistance will be in the form of email contact with the participant during the first two weeks after randomization. AHC+A will be tested against a group receiving access to the intervention without any such assistance (AHC).
The Investigators hypothesize that
- participants allocated to AHC+A will display significant reductions in drinking (drinks preceding week/heavy drinking days preceding week) in 3- and 6-month follow ups compared to AHC
- participants allocated to AHC+A will display greater engagement with the intervention in terms of a higher number of modules completed compared to AHC
- engagement with the intervention will mediate any effects on drinking behavior.
A 2-arm parallel group randomized controlled trial will be used to test these specified hypotheses. Follow-ups will be conducted at 3 and 6 months after randomization. Online media advertisements will be used to recruit people with current alcohol problems, and will target people who are 'experiencing difficulties in controlling or cutting down on their drinking.' The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A score of 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)
- •A preceding week alcohol consumption of 14 standard drinks or more
排除标准
- •Being under 18 years of age
研究组 & 干预措施
Internet intervention with assistance
This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization.
干预措施: Alcohol Help Center (Behavioral)
Internet intervention with assistance
This arm is given access to the internet intervention Alcohol Help Center with email assistance from a health educator during the first two weeks after randomization.
干预措施: Assistance from a health educator (Behavioral)
Internet intervention without assistance
This arm is given access to the internet intervention Alcohol Help Center without any assistance from a health educator.
干预措施: Alcohol Help Center (Behavioral)
结局指标
主要结局
Drinks preceding week
时间窗: 3 and 6 months
Change in the number of standard drinks consumed during preceding week from baseline
Heavy drinking days preceding week
时间窗: 3 and 6 months
Change in the number of heavy drinking days during preceding week from baseline
次要结局
- Alcohol Use Disorders Identification Test (AUDIT)(Baseline, 3 month follow up, 6 month follow up)
- DSM criteria(Baseline)
- Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)(Baseline, 3 month follow up, 6 month follow up)
- EuroQol Group 5 Dimensions Five Levels (EQ-5D-5L)(Baseline, 3 month follow up, 6 month follow up)
- Previously received treatment or help for alcohol concerns(Baseline (treatment or help ever/in the past 12 months), 3 month follow up (treatment or help in the past 3 months), 6 month follow up (treatment or help in the past 3 months))
研究者
John Cunningham
Senior Scientist
Centre for Addiction and Mental Health