A Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Drug Use Disorders Addiction, Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Integrated rehabilitation group

Participants will receive the standardized community-based rehabilitation and simultaneously receive a 6-month integrated rehabilitation based on the Community-based Addiction Rehabilitation Electronic System.

Group Type EXPERIMENTAL

Integrated rehabilitation group

Intervention Type OTHER

Participant in integrated rehabilitation group needs to visit their corresponding social worker and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary. The integrated rehabilitation group received the standardized community-based rehabilitation described above and simultaneously received a 6-month integrated rehabilitation based on CAREs (Community-based Addiction Rehabilitation Electronic System).CAREs was developed by the department of addiction research in Shanghai Mental Health Center(SMHC), with functions including education, support, psychological intervention and other functions.

Community-based rehabilitation group

Participants will receive the standardized community-based rehabilitation.

Group Type ACTIVE_COMPARATOR

Community-based rehabilitation group

Intervention Type OTHER

Participant in community-based rehabilitation group needs to visit their corresponding social worker for six months and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary.

Interventions

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Integrated rehabilitation group

Participant in integrated rehabilitation group needs to visit their corresponding social worker and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary. The integrated rehabilitation group received the standardized community-based rehabilitation described above and simultaneously received a 6-month integrated rehabilitation based on CAREs (Community-based Addiction Rehabilitation Electronic System).CAREs was developed by the department of addiction research in Shanghai Mental Health Center(SMHC), with functions including education, support, psychological intervention and other functions.

Intervention Type OTHER

Community-based rehabilitation group

Participant in community-based rehabilitation group needs to visit their corresponding social worker for six months and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (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.

Exclusion Criteria

* (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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No