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研究方案:一项针对接受住院药物滥用治疗的人群进行健康生活方式干预的阶梯式楔形整群随机对照试验。

Study protocol: a stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment.

作者信息

Kelly Peter J, Baker Amanda L, Deane Frank P, Callister Robin, Collins Clare E, Oldmeadow Christopher, Attia John R, Townsend Camilla J, Ingram Isabella, Byrne Gerard, Keane Carol A

机构信息

Illawarra Institute for Mental Health, School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, 2522, Australia.

School of Medicine and Public Health, Faculty of Medicine, University of Newcastle, University Drive, Callaghan, 2308, Australia.

出版信息

BMC Public Health. 2015 May 3;15:465. doi: 10.1186/s12889-015-1729-y.

DOI:10.1186/s12889-015-1729-y
PMID:25935830
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4433090/
Abstract

BACKGROUND

Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders. These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use, smoking, low intake of fruit and vegetables and physical inactivity. In addition to addressing problematic alcohol use, there is the potential for substance abuse treatment services to also address these other behaviours. Healthy Recovery is an 8-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment. This protocol describes a Cancer Institute NSW funded study that assesses the effectiveness of delivering Healthy Recovery for people who are attending residential alcohol and other substance abuse treatment.

METHODS/DESIGN: The study uses a stepped wedge randomised controlled design, where randomisation occurs at the service level. Participants will be recruited from residential rehabilitation programs provided by The Australian Salvation Army. All participants who (1) currently smoke tobacco and (2) are expected to be in the residential program for the duration of the 5-week intervention will be asked to participate in the study. Those participants residing at the facilities assigned to the treatment condition will complete Healthy Recovery. The intervention is manual guided and will be delivered over a 5-week period, with participants attending 8 group sessions. All participants will continue to complete The Salvation Army residential program, a predominantly 12-step based, modified therapeutic community. Participants in the control condition will complete treatment as usual. Research staff blind to treatment allocation will complete the primary and secondary outcome assessments at baseline and then at weeks 8, 20 and 32 weeks post intervention.

DISCUSSION

This study will provide comprehensive data on the effect of delivering a healthy lifestyle intervention (i.e. Healthy Recovery) within a residential substance abuse setting. If shown to be effective, this intervention can be disseminated within other residential substance abuse programs.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12615000165583. Registered 19(th) February 2015.

摘要

背景

心血管疾病和癌症是有酒精或其他物质使用障碍病史人群的主要死因。这些慢性疾病有相同的四个主要行为风险因素,即过度饮酒、吸烟、水果和蔬菜摄入量低以及身体活动不足。除了解决有问题的酒精使用问题外,物质滥用治疗服务还有可能解决这些其他行为问题。“健康康复”是一种基于小组的八节干预课程,针对这些多种行为健康风险因素,专门为接受物质滥用治疗的人群开发。本方案描述了一项由新南威尔士州癌症研究所资助的研究,该研究评估了为接受住院酒精和其他物质滥用治疗的人群提供“健康康复”课程的效果。

方法/设计:该研究采用阶梯式楔形随机对照设计,随机化在服务层面进行。参与者将从澳大利亚救世军提供的住院康复项目中招募。所有(1)目前吸烟且(2)预计在为期5周的干预期间参加住院项目的参与者将被邀请参加该研究。居住在分配到治疗组设施中的参与者将完成“健康康复”课程。该干预由手册指导,将在5周内进行,参与者参加8次小组课程。所有参与者将继续完成救世军住院项目,这是一个主要基于12步的改良治疗社区。对照组的参与者将照常完成治疗。对治疗分配不知情的研究人员将在基线时以及干预后第8、20和32周完成主要和次要结局评估。

讨论

本研究将提供关于在住院物质滥用环境中提供健康生活方式干预(即“健康康复”)效果的全面数据。如果证明有效,该干预可在其他住院物质滥用项目中推广。

试验注册

澳大利亚和新西兰临床试验注册中心(ANZCTR):ACTRN12615000165583。2015年2月19日注册。

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Clinical and reliable change in an Australian residential substance use program using the Addiction Severity Index.澳大利亚住宅物质使用项目中使用成瘾严重程度指数的临床和可靠变化。
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There are some circumstances where the stepped-wedge cluster randomized trial is preferable to the alternative: no randomized trial at all. Response to the commentary by Kotz and colleagues.在某些情况下,阶梯楔形整群随机试验比另一种选择(即根本不进行随机试验)更可取。对Kotz及其同事评论的回应。
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