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

S

Shanghai Mental Health Center

Status

Completed

Conditions

Drug Use Disorders
Addiction, Drug

Treatments

Other: Community-based rehabilitation group
Other: Integrated rehabilitation group

Study type

Interventional

Funder types

Other

Identifiers

NCT03451344
HFJiang

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Integrated rehabilitation group
Experimental group
Description:
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.
Treatment:
Other: Integrated rehabilitation group
Community-based rehabilitation group
Active Comparator group
Description:
Participants will receive the standardized community-based rehabilitation.
Treatment:
Other: Community-based rehabilitation group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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