针对英国武装部队中饮酒量处于危险或有害水平的女性的数字疗法干预：一项随机对照试验方案

Digital Therapeutic Intervention for Women in the UK Armed Forces Who Consume Alcohol at a Hazardous or Harmful Level: Protocol for a Randomized Controlled Trial.

作者信息

Williamson Grace, Carr Ewan, Fear Nicola T, Dymond Simon, King Kate, Simms Amos, Goodwin Laura, Murphy Dominic, Leightley Daniel

机构信息

King's Centre for Military Health Research, King's College London, London, United Kingdom.

Biostatistics & Health Informatics, King's College London, London, United Kingdom.

出版信息

JMIR Res Protoc. 2023 Dec 19;12:e51531. doi: 10.2196/51531.

DOI:10.2196/51531

PMID:38113103

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10762616/

Abstract

BACKGROUND

Alcohol misuse is common in the United Kingdom Armed Forces (UKAF), with prevalence significantly higher than in the general population. To date, digital health initiatives to support alcohol misuse have focused on male individuals, who represent approximately 89% of the UKAF. However, female veterans drink disproportionally more than female members of the public.

OBJECTIVE

This 2-arm participant-blinded (single-blinded) confirmatory randomized controlled trial (RCT) aims to assess the efficacy of a brief alcohol intervention (DrinksRation) in reducing weekly self-reported alcohol consumption between baseline and a 3-month follow-up (day 84) among women who have served in the UKAF.

METHODS

In this 2-arm single-blinded RCT, a smartphone app that includes interactive user-focused features tailored toward the needs of female veterans and designed to enhance participants' motivations to reduce the amount of alcohol they consume is compared with the UK Chief Medical Officer guidance on alcohol consumption. The trial will be conducted among women who have served at least 1 day of paid service in the UKAF. Recruitment, consent, and data collection will be carried out automatically through the DrinksRation app or the BeAlcoholSmart platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and the 3-month follow-up (day 84) measured using the Timeline Follow Back for alcohol consumption. The secondary outcome is the change in the Alcohol Use Disorders Identification Test score measured at baseline and 3-month follow-up between the control and intervention groups. The process evaluation measures include (1) app use and (2) usability ratings as measured by the mHealth App Usability Questionnaire.

RESULTS

RCT recruitment will begin in January 2024 and last for 5 months. We aim to complete all data collection, including interviews, by May 2024.

CONCLUSIONS

This study will assess whether a smartphone app tailored to the needs of women who have served in the UKAF is efficacious in reducing self-reported alcohol consumption. If successful, the digital therapeutics platform could be used not only to support women who have served in the UKAF but also for other conditions and disorders.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05970484; https://www.clinicaltrials.gov/study/NCT05970484.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51531.

摘要

背景

酒精滥用在英国武装部队（UKAF）中很常见，其患病率显著高于普通人群。迄今为止，支持酒精滥用问题的数字健康倡议主要针对男性个体，他们约占英国武装部队的89%。然而，女性退伍军人饮酒量比普通女性多得多。

目的

这项双臂参与者设盲（单盲）验证性随机对照试验（RCT）旨在评估简短酒精干预措施（DrinksRation）在减少英国武装部队女性服役人员从基线到3个月随访期（第84天）每周自我报告的酒精摄入量方面的效果。

方法

在这项双臂单盲RCT中，将一款智能手机应用程序与英国首席医疗官关于酒精消费的指南进行比较。该应用程序具有针对女性退伍军人需求量身定制的交互式用户导向功能，旨在增强参与者减少饮酒量的动机。该试验将在至少有1天英国武装部队有偿服役经历的女性中进行。招募、同意和数据收集将通过DrinksRation应用程序或BeAlcoholSmart平台自动进行。主要结局是使用酒精消费时间线追溯法测量的从基线（第0天）到3个月随访期（第84天）自我报告的每周酒精摄入量的变化。次要结局是对照组和干预组在基线和3个月随访时测量的酒精使用障碍识别测试分数的变化。过程评估指标包括：（1）应用程序使用情况；（2）通过移动健康应用程序可用性问卷测量的可用性评级。