Wang Zhe, Chen Shujuan, Chen Junning, Xu Chunfeng, Chen Zhikang, Zhuang Wenxu, Li Xu, Zhao Min, Haifeng Jiang
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Nantong Winner Information Technology Co., Ltd, Nantong, China.
Front Psychiatry. 2018 Nov 6;9:556. doi: 10.3389/fpsyt.2018.00556. eCollection 2018.
Relapse is very common in drug abusers and contributes to a series of negative consequences. Effective addiction treatment exists but there are some problems in the implementation process. Mobile health (mHealth) offers a potential solution to improving recovery outcome for drug abusers in the community. The research team developed a community-based addiction rehabilitation electronic system (CAREs). The primary aim of this study is to explore whether the integrated rehabilitation based on program CAREs promotes drug abusers to keep abstinence. The secondary aim is to evaluate the impact of CAREs on interaction between drug users and service providers, and on addiction-related physical and social functions. A randomized controlled trial (RCT) will be conducted. The study is a superiority trial with parallel group design. Seventy drug abusers who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding social workers will provide service and monitor their drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary outcome is the performance on illicit drug urine test which will be carried out regularly twice per week during the study period. Secondary study outcomes include longest duration of sustained abstinence, days that participants interact with social workers, and the decrease rate of addiction-related issues severity index. Chi-square tests and ANOVAs will be used to compare characteristics of the members of the two groups. GEE will be used to compare the seven dimensions scores of the ASI between groups. The study provides evidence for the feasibility and effectiveness of the "CAREs" system through comparing the results of the intervention group with the control group. This paper describes the design and methodology of the study. The Ethical Board of SMHC approved the study protocol. All participants will present for the informed consent process. After study completion, the results will be published. ClinicalTrials.gov NCT03451344, https://clinicaltrials.gov/ct2/show/NCT03451344.
复吸在药物滥用者中非常常见，并会导致一系列负面后果。有效的成瘾治疗方法是存在的，但在实施过程中存在一些问题。移动健康（mHealth）为改善社区中药物滥用者的康复效果提供了一种潜在的解决方案。研究团队开发了一个基于社区的成瘾康复电子系统（CAREs）。本研究的主要目的是探讨基于CAREs计划的综合康复是否能促进药物滥用者保持戒断状态。次要目的是评估CAREs对吸毒者与服务提供者之间互动以及与成瘾相关的身体和社会功能的影响。将进行一项随机对照试验（RCT）。该研究是一项采用平行组设计的优效性试验。将从上海社区招募70名新被要求接受社区康复的药物滥用者。参与者将按1:1随机分配，接受使用CAREs的综合社区康复或仅接受常规社区康复，为期6个月。相应的社会工作者将按照常规工作流程提供服务并监测他们的吸毒行为。将在基线和第6个月评估结果。主要结局是非法药物尿液检测结果，在研究期间每周将定期进行两次检测。次要研究结局包括最长持续戒断时间、参与者与社会工作者互动的天数以及成瘾相关问题严重程度指数的下降率。将使用卡方检验和方差分析来比较两组成员的特征。将使用广义估计方程（GEE）来比较两组之间成瘾严重程度量表（ASI）的七个维度得分。通过将干预组与对照组的结果进行比较，本研究为“CAREs”系统的可行性和有效性提供了证据。本文描述了该研究的设计和方法。上海交通大学医学院附属新华医院伦理委员会批准了研究方案。所有参与者都将参加知情同意程序。研究完成后，将公布结果。ClinicalTrials.gov标识符：NCT03451344，https://clinicaltrials.gov/ct2/show/NCT03451344
