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临床试验/NCT03451344
NCT03451344已完成不适用

A Community-based Addiction Rehabilitation Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder: Protocol for a Randomized Controlled Trial

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Drug urine test

研究概览

简要总结

Background: Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact patients' physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community.

Objective: This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs) . This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve work efficiency and effectiveness in community.

Methods: A randomized controlled trial(RCT) will be conducted. Sixty drug illicit users 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 anti-drug social workers will provide service and monitor participants' drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

To minimize the risk of biased results as much as possible, the persons who conduct the urine tests and complete the evaluation of the ASI will be different from those who provides the intervention. But subjects may talk about the CAREs intervention during the assessment so it is not possible to completely 'blind' the evaluators to the intervention group of the subjects.

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (1)Illicit drug users who are newly ordered to undergoing community-based rehabilitation will be recruited for the study.
  • (2)Candidates are eligible to participated in if they are aged 20 - 50 years
  • (3)Candidates are eligible to participated in if they are meeting the DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for substance dependence
  • (4)Candidates are eligible to participated in if they are willing to comply with the relevant requirements of the study including using the mobile app
  • (5)There is no limitation for Gender when recruiting participant.

排除标准

  • (1)Illicit drug users who are not newly ordered to undergoing community-based rehabilitation.
  • (2)Candidates' age is less than 20 or older than 50
  • (3)Candidates does not meet the DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for substance dependence
  • (4)Candidates are not able to use the mobile app

结局指标

主要结局

Drug urine test

时间窗: Up to six months

The results of drug urine tests will be examined in overall percentage of drug positive samples. Overall percentage of drug positive samples= the number of positive urine tests results / the number of total urine tests (Subject who does not submit urine samples on time during the intervention period or refuses to submit samples even if he/she is present at the site will be considered as having a positive urine test result).

次要结局

  • The decrease rate of addiction-related issues severity index(Up to six months)
  • Longest duration of sustained abstinence(Up to six months)
  • Interacting with anti-drug social workers(Up to six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haifeng Jiang

Attending physician

Shanghai Mental Health Center

研究点 (1)

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