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临床试验/NCT01544803
NCT01544803已完成2 期

Randomized Controlled Trial of eScreen for Problematic Alcohol Use

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 633 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
633
试验地点
1
主要终点
Change in the total AUDIT-C score

研究概览

简要总结

Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. A more extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.

Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related symptoms are assessed after 3, 6 and 12 months.

The first hypothesis is that all three groups will reduce their alcohol consumption and alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis is that there will be no differences between participants in the eScreen and the Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen group will show a greater reduction in alcohol consumption and alcohol-related problems compared to the control group (no intervention) at follow-ups. For a greater understanding of the study results possible other interventions received by the study participants for their problematic alcohol use during these 12 months of study participation will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
15 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Problematic alcohol use. AUDIT>7 for men and AUDIT>5 for women

排除标准

  • •Drug use DUDIT>0
  • •Unproblematic alcohol use, AUDIT<8 for men and AUDIT<6 for women

研究组 & 干预措施

Control group

No Intervention

Web based self-monitoring

Experimental

干预措施: eScreen (Behavioral)

Web based self-help

Active Comparator

干预措施: Alkoholhjalpen (Behavioral)

结局指标

主要结局

Change in the total AUDIT-C score

时间窗: 3, 6 and 12 months

The primary outcome measure for this trial was the change in the total AUDIT score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.

次要结局

  • AUDIT(3, 6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne H Berman

Associate Professor

Karolinska Institutet

研究点 (1)

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