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数字酒精节制干预作为附加治疗对年轻人抑郁症的疗效:一项多中心实用随机对照试验的研究方案。

Effectiveness of a digital alcohol moderation intervention as an add-on to depression treatment for young adults: study protocol of a multicentre pragmatic randomized controlled trial.

机构信息

Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.

Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands.

出版信息

BMC Psychiatry. 2021 May 22;21(1):265. doi: 10.1186/s12888-021-03222-1.

DOI:10.1186/s12888-021-03222-1
PMID:34022840
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8140318/
Abstract

BACKGROUND

Depressive disorders and problematic drinking often co-occur, also among young adults. These co-occurring conditions are associated with various negative health outcomes compared to both conditions alone. Early intervention by addressing alcohol use and depressive symptoms simultaneously in the same treatment might improve both conditions. However, evidence on the (cost-) effectiveness of digital combined depression and alcohol interventions for young adults is currently insufficient. We therefore developed an add-on digital alcohol moderation adherence-focussed guided intervention to complement treatment as usual (TAU) for depressive disorders. The digital intervention is a web-app, including 6 modules based on motivational interviewing and cognitive behavioural therapy. This study aims to evaluate the (cost-)effectiveness of a digital alcohol moderation intervention + TAU compared to TAU on alcohol and depression outcomes among young adults with co-occurring depressive disorders and problematic alcohol use.

METHODS

One hundred fifty-six participants, aged 18-35 years, with problematic alcohol use and a diagnosed depressive disorder will participate in a pragmatic multicentre two-arm randomized controlled trial. Problematic alcohol use is operationalised as scoring ≥5 for women and ≥ 8 for men on the Alcohol Use Disorder Identification Test (AUDIT). Participants will be randomized to either the experimental group (digital alcohol intervention + TAU) or control group (TAU only). Participants will be recruited at three Dutch mental health care centres and through social media. Assessments take place at baseline and after 3, 6 and 12 months post-randomization. The primary outcome is treatment response at 6-month follow-up, operationalized as a composite score that combines alcohol use and depression measures and indicates whether treatment has been successful or not. Secondary outcomes are depressive symptoms and alcohol use (i.e. number of weekly standard drinks and AUDIT score). An economic evaluation will be conducted alongside the trial.

DISCUSSION

This study evaluates the (cost-) effectiveness of an add-on digital alcohol moderation intervention for young adults who are in treatment for depressive disorders. If proven effective, the digital intervention could be implemented in mental health care and improve treatment for people with co-occurring depressive disorders and problematic alcohol use.

TRIAL REGISTRATION

Pre-registered on October 29, 2019 in The Netherlands Trial Register ( NL8122 ).

摘要

背景

抑郁障碍和问题性饮酒经常同时发生,在年轻人中也是如此。与仅存在这两种情况相比,这些同时存在的情况与各种负面健康结果相关。通过在同一治疗中同时解决酒精使用和抑郁症状,早期干预可能会改善这两种情况。然而,目前关于针对年轻人的数字联合抑郁和酒精干预的(成本)有效性的证据还不够充分。因此,我们开发了一种附加的数字酒精适度依从性聚焦的指导干预措施,以补充针对抑郁障碍的常规治疗(TAU)。数字干预是一个网络应用程序,包括基于动机访谈和认知行为疗法的 6 个模块。本研究旨在评估数字酒精适度干预+TAU 与 TAU 相比,对同时存在抑郁障碍和问题性酒精使用的年轻人的酒精和抑郁结果的(成本)有效性。

方法

156 名年龄在 18-35 岁之间、有问题性饮酒且被诊断为抑郁障碍的参与者将参加一项实用的、多中心的、两臂随机对照试验。问题性饮酒的定义是女性酒精使用障碍识别测试(AUDIT)得分≥5,男性得分≥8。参与者将被随机分配到实验组(数字酒精干预+TAU)或对照组(仅 TAU)。参与者将在三个荷兰心理健康护理中心和社交媒体上招募。评估在基线时以及随机分组后 3、6 和 12 个月时进行。主要结局是 6 个月随访时的治疗反应,用结合了酒精使用和抑郁测量的综合评分来表示治疗是否成功。次要结局是抑郁症状和酒精使用(即每周标准饮料数和 AUDIT 评分)。一项经济评估将与试验同时进行。

讨论

本研究评估了针对正在接受抑郁障碍治疗的年轻人的附加数字酒精适度干预的(成本)有效性。如果证明有效,数字干预可以在精神卫生保健中实施,并改善同时存在抑郁障碍和问题性酒精使用的人的治疗效果。

试验注册

于 2019 年 10 月 29 日在荷兰试验注册处(NL8122)预先注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3484/8140493/76427866178a/12888_2021_3222_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3484/8140493/f1515db4eb1c/12888_2021_3222_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3484/8140493/76427866178a/12888_2021_3222_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3484/8140493/f1515db4eb1c/12888_2021_3222_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3484/8140493/76427866178a/12888_2021_3222_Fig2_HTML.jpg

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