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以在线戒酒训练强化常规门诊酒精治疗:一项双盲随机对照试验方案

Augmenting Outpatient Alcohol Treatment as Usual With Online Alcohol Avoidance Training: Protocol for a Double-Blind Randomized Controlled Trial.

作者信息

Bratti-van der Werf Marleen Kj, Laurens Melissa C, Postel Marloes G, Pieterse Marcel E, Ben Allouch Somaya, Wiers Reinout W, Bohlmeijer Ernst T, Salemink Elske

机构信息

Technology, Health & Care Research Group, Saxion University of Applied Sciences, Enschede, Netherlands.

Centre for eHealth and Well-Being Research, Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.

出版信息

JMIR Res Protoc. 2018 Mar 1;7(3):e55. doi: 10.2196/resprot.9287.

Abstract

BACKGROUND

Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically.

OBJECTIVE

The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting.

METHODS

The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients' adherence, acceptability, and credibility will be examined.

RESULTS

The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020.

CONCLUSIONS

The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment.

TRIAL REGISTRATION

Netherlands Trial Register NTR5087; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5087 (Archived at WebCite http://www.webcitation.org/6wuS4i1tH).

摘要

背景

最近的理论模型强调冲动过程在酒精成瘾中的作用,这种作用可通过计算机化认知偏差修正(CBM)训练进行重塑。在本研究中,重点关注相对自动激活的行动倾向。

目的

本研究旨在检验在门诊治疗环境中,使用适应性的趋避任务作为常规治疗(TAU)补充的在线CBM酒精回避训练的有效性。

方法

在一项双盲、随机对照试验中,对添加到TAU中的8次在线CBM酒精回避训练的有效性进行测试,试验包括前后评估,以及3个月和6个月后的随访评估。参与者为成年患者(18岁及以上),目前正在接受基于网络或面对面的TAU以减少或停止饮酒。这些患者被随机分配到CBM酒精回避训练组或安慰剂训练组。主要结局指标是酒精消费量的减少。我们假设,与TAU + 安慰剂CBM相比,TAU + CBM在达到安全饮酒指南的患者数量上会产生高达13个百分点的增量效应。次要结局指标包括健康状况的改善以及抑郁、焦虑、压力的减轻,以及趋避偏差变化可能产生的中介作用。最后,将检查患者的依从性、可接受性和可信度。

结果

该试验于2014年获得资助,目前处于积极招募参与者阶段(自2015年5月起)。招募工作将于2019年完成。预计2020年提交首批结果以发表。

结论

本研究的主要目的是增加我们对在线酒精回避训练作为门诊治疗环境中TAU补充的附加价值的认识。如果训练的附加有效性得到证实,下一步可能是将该干预措施纳入当前治疗。

试验注册

荷兰试验注册库NTR5087;http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5087(存档于WebCite http://www.webcitation.org/6wuS4i1tH)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64d8/5856929/0047653d7e15/resprot_v7i3e55_fig1.jpg

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