Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
2026年9月11日 更新者：Kristina Sinadinovic、Karolinska Institutet
Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:
- The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
- The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.
The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:
Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
研究概览
研究类型
介入性
注册 (实际的)
303
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Stockholm、瑞典、171 77
- Karolinska Institutet
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
Inclusion Criteria:
- 18 years or older
- 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
- Resident in Stockholm County
Exclusion Criteria:
- Lack of understanding of the Swedish language.
- Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
- Doctor's assessment that there is a need for medication for alcohol dependence.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Internet-based treatment
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
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A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
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有源比较器：Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
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A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
大体时间：3 months post-randomization
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3 months post-randomization
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
大体时间：6 months post-randomization
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6 months post-randomization
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
大体时间：12 months post-randomization
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12 months post-randomization
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
大体时间：24 months post-randomization
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24 months post-randomization
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Alcohol Use Disorders Identification Test score
大体时间：3 months post-randomization
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3 months post-randomization
|
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Alcohol Use Disorders Identification Test score
大体时间：6 months post-randomization
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6 months post-randomization
|
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Alcohol Use Disorders Identification Test score
大体时间：12 months post-randomization
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12 months post-randomization
|
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Alcohol Use Disorders Identification Test score
大体时间：24 months post-randomization
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24 months post-randomization
|
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
大体时间：3 months post-randomization
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3 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
大体时间：6 months post-randomization
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6 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
大体时间：12 months post-randomization
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12 months post-randomization
|
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
大体时间：24 months post-randomization
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24 months post-randomization
|
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
大体时间：3 months post-randomization
|
3 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
大体时间：6 months post-randomization
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6 months post-randomization
|
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
大体时间：12 months post-randomization
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12 months post-randomization
|
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
大体时间：24 months post-randomization
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24 months post-randomization
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Number of days absent from work due to illness
大体时间：3 months post-randomization
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3 months post-randomization
|
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Number of days absent from work due to illness
大体时间：6 months post-randomization
|
6 months post-randomization
|
|
Number of days absent from work due to illness
大体时间：12 months post-randomization
|
12 months post-randomization
|
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Number of days absent from work due to illness
大体时间：24 months post-randomization
|
24 months post-randomization
|
|
Score on Montgomery-Åsberg Depression Rating Scale
大体时间：3 months post-randomization
|
3 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
大体时间：6 months post-randomization
|
6 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
大体时间：12 months post-randomization
|
12 months post-randomization
|
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Score on Montgomery-Åsberg Depression Rating Scale
大体时间：24 months post-randomization
|
24 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
大体时间：3 months post-randomization
|
3 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
大体时间：6 months post-randomization
|
6 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
大体时间：12 months post-randomization
|
12 months post-randomization
|
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Score on Generalised Anxiety Disorder 7-item scale
大体时间：24 months post-randomization
|
24 months post-randomization
|
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Score on EQ-5D measuring the quality of life
大体时间：3 months post-randomization
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3 months post-randomization
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Score on EQ-5D measuring the quality of life
大体时间：6 months post-randomization
|
6 months post-randomization
|
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Score on EQ-5D measuring the quality of life
大体时间：12 months post-randomization
|
12 months post-randomization
|
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Score on EQ-5D measuring the quality of life
大体时间：24 months post-randomization
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24 months post-randomization
|
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Cost for treatment
大体时间：3 months post-randomization
|
3 months post-randomization
|
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Cost for treatment
大体时间：6 months post-randomization
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6 months post-randomization
|
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Cost for treatment
大体时间：12 months post-randomization
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12 months post-randomization
|
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Cost for treatment
大体时间：24 months post-randomization
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24 months post-randomization
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月12日
初级完成 (实际的)
2020年3月31日
研究完成 (实际的)
2025年3月31日
研究注册日期
首次提交
2016年1月11日
首先提交符合 QC 标准的
2016年2月1日
首次发布 (估计的)
2016年2月2日
研究记录更新
最后更新发布 (实际的)
2026年9月15日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.