Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 2
- 主要终点
- Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
研究概览
简要总结
This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. The Telecoach web app delivers skills training in the form of exercises commonly used in psychosocial interventions for risky alcohol use. The controll condition is a web app providing information on the effects of alcohol on the consumers' health.
详细描述
This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering.
Individuals seeking help for problematic alcohol use on the internet will get access to a webpage with information about the study. Individuals leaving informed consent are asked to fill out questionnaires about alcohol use, depression, anxiety and information on gender and weight. Those with excessive alcohol use (>14 standard glasses/week for men and > 9 for women) are randomized into one of two groups: 1. Access to the Telecoach web-app and 2. Access to a control condition with an information-providing web-app.
Outcomes on alcohol use are gathered by electronic self-registration at 6, 12 and 26 weeks after study initiation. Additional questions on the users' satisfaction with the app assigned to them and other support for problematic alcohol used during the research period at 26 weeks.
The Telecoach web-app is a skills-training app developed for use on a mobile smart-phone. The skills-training components are common to psychosocial treatment protocols for problematic alcohol consumption.
The control condition web-app is a simple text-based app providing information on the effects of alcohol on the consumers' health.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •Risky alcohol consumption defined as Alcohol Use Disorders Identification Test (AUDIT) scores of ≥6 points for women and ≥ 8 points for men.
排除标准
- •Severe depression, defined as a MADRS-S score of > 30
- •Sucide risk, defined as a MADRS-S, item 9 (Lust for life) score > 4
- •Drug abuse, defined as a score of ≥ 8 on the DUDIT
结局指标
主要结局
Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)
时间窗: Time between screening measure and 26-week followup
Change in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared.
次要结局
- Penn Alcohol Craving Scale (PACS)(Baseline, 6, 12 and 26 week followups.)
- Drug Use Disorders Identification Test (DUDIT)(Baseline)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline, 6, 12 and 26 week followups.)
- Treatment questions (7 questions regarding access to other help and support for problematic alcohol use).(Baseline and 26 week followup.)
- Usability questions regarding the participants' experience of using the web-app they were assigned.(26 week followup)
- Daily Drinking Questionnaire (DDQ)(Baseline, 6, 12 and 26 week followups.)
- Alcohol Use Disorders Identification Test (AUDIT)(Baseline and 26-week followup.)
- Change in alcohol consumption according to the 7-day Timeline Followback (TLFB)(Baseline, 6- and 12-week followups.)
- Montgomery Åsberg Depression Rating Scale - Self-rating version (MADRS-S)(Baseline, 6, 12 and 26 week followups.)
- Readiness Ruler(Baseline and 26-week followup.)
- DSM-5 Alcohol use disorder criteria.(Baseline)
- Alcohol Abstinence Self Efficacy scale (AASE)(Baseline, 6, 12 and 26 week followups.)
研究者
Anne H Berman
Associate Professor
Karolinska Institutet