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临床试验/NCT01958359
NCT01958359已完成不适用

Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2011年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
2
主要终点
AUDIT

研究概览

简要总结

Objectives: The study evaluates the efficacy of two automated telephony, also known as, Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short IVR works as an interactive alcohol diary where the user is contacted once a week for four weeks to register their alcohol consumption during the preceding week. The user is given feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR contacts the user once a week for four weeks and is also available for user-initiated calls 24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu where the user chooses among listening to vignettes and doing exercises with the purpose of looking at alcohol consumption and exploring ways of coping with it.

Method: The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up six months after study initiation and baseline data gathering. Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: 1. Short IVR, 2. Therapeutic IVR and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the intervention are assessed after 6 months.

The primary hypothesis for this study is that having access to one of the two IVR interventions will lead to a greater reduction of problematic alcohol use compared to controls who undergo only screening and follow-up assessment. The secondary hypothesis is that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in risky drinking.

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 (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AUDIT >7 for men or AUDIT >5 for women.

排除标准

  • AUDIT <8 (men) or <6 (women)

研究组 & 干预措施

Short IVR

Experimental

IVR-based alcohol diary with feedback

干预措施: Short IVR (Behavioral)

Therapeutic IVR

Experimental

IVR-based conversation offering a menu of exercises and vignettes.

干预措施: Therapeutic IVR (Behavioral)

Control

No Intervention

Untreated control group

结局指标

主要结局

AUDIT

时间窗: 6 months

Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).

次要结局

  • User satisfaction(6 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 (2)

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