Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- number of standard alcohol units consumed during the previous seven days
研究概览
简要总结
The purpose of this study is to test whether an online multi session alcohol intervention improves treatment effect compared to single session screening with feedback only.
All participants in the trial received a single session screening procedure including individualized normative feedback (usual care). Additionally, half of the participants received a simple online booklet about the effects of alcohol. The other half received an online multi session follow up program.
详细描述
Aims: Test whether a multi session alcohol intervention improves treatment effect (i.e., reduced consumption of alcohol) compared to single session screening with feedback.
Design: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program "Balance" .
Setting: Online study in Norway. Participants: At-risk drinkers is recruited through internet advertisements and randomly assigned to one of two conditions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hazardous or harmful drinking (i.e., a FAST-score of 3 or more)
排除标准
- •underage (<18)
- •not provided a valid e-mail address
- •not provided a valid (Norwegian) mobile phone number
研究组 & 干预措施
Usual care
Receives two interventions:
- Online screening and feedback.
- Online booklet.
干预措施: Online screening and feedback (Behavioral)
Usual care
Receives two interventions:
- Online screening and feedback.
- Online booklet.
干预措施: Online booklet. (Behavioral)
Extended follow-up
Receives two interventions:
- Online screening and feedback.
- Online multi session follow-up.
干预措施: Online screening and feedback (Behavioral)
Extended follow-up
Receives two interventions:
- Online screening and feedback.
- Online multi session follow-up.
干预措施: Online multi session follow-up (Behavioral)
结局指标
主要结局
number of standard alcohol units consumed during the previous seven days
时间窗: measures six months after baseline (enrollment)
Subjects are asked to indicate (through online questionnaires) how many standard alcohol units they consumed on each of the previous seven days, on a scale from zero to ten. Then a sum-score for weekly consumption is calculated, ranging from zero to 70.
次要结局
- Negative consequences of alcohol consumption(Assessed at six months post baseline)
- Sick leave during last week(Assessed at six months post baseline)
- Number of days with alcohol consumption(Six months post baseline)
- Number of alcohol binges(Six months post baseline)
- Change in alcohol consumption(Six months post baseline)
研究者
Håvar Brendryen
Research fellow. PhD.
University of Oslo