Skills-training for Reducing Risky Alcohol Use in App Form
赞助:
Karolinska Institutet
合作者:
信息的提供 (责任方):
Anne H Berman，Karolinska Institutet
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change (reduction) in alcohol consumption according to the 7-day Timeline Followback (TLFB)[ Time Frame: Time between baseline measure and 26-week followup ] Reduction in the total number of standard glasses (12g of ethanol) consumed for each day of the preceding 7 days at each timepoint compared. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Skills-training for Reducing Risky Alcohol Use in App Form | ||
| 正式标题 ICMJE | Reducing Risky Alcohol Consumption Using Skills-training in the App-form: A Randomized Controlled Study in the General Population. | ||
| 简要概况 | 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. |
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| 详细说明 | 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. Outcomes will be reported, analyzed and discussed in scientific article. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
1000 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 31, 2019 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - ≥ 18 years - excessive alcohol consumption defined as > 14 standard glasses for men and > 9 standard glasses or more for women on the TLFB. Exclusion Criteria: - 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 - fulfill 6 or more criteria for alcohol use disorder as defined in DSM-5 | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Sweden | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Anne H Berman，Karolinska Institutet | ||
| 研究赞助商 ICMJE | Karolinska Institutet | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Karolinska Institutet | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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