A Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder
- Conditions
- Drug Use DisordersAddiction, Drug
- Interventions
- Other: Community-based rehabilitation groupOther: Integrated rehabilitation group
- Registration Number
- NCT03451344
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- (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.
- (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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Community-based rehabilitation group Community-based rehabilitation group Participants will receive the standardized community-based rehabilitation. Integrated rehabilitation group 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.
- Primary Outcome Measures
Name Time Method Drug urine test 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).
- Secondary Outcome Measures
Name Time Method The decrease rate of addiction-related issues severity index Up to six months The Chinese translation of the Addiction Severity Index (ASI) that has good reliability and validity in China will be used to assess the severity of addiction at enrollment and 6 months after enrollment. The descent rate will be counted via dividing the minus value between baseline score and 6-month score by baseline score.
Longest duration of sustained abstinence Up to six months Longest duration of sustained abstinence will be measured by drug urine tests and will be reported in weeks(the most consecutive weeks of drug negative samples).
Interacting with anti-drug social workers Up to six months Interaction with anti-drug social workers: The days that participants interact with their corresponding social workers will be collected during the study period. Any phone call, SMS, face-to-face meeting, or communication via CAREs will be considered as interaction happening.
Trial Locations
- Locations (1)
Haifeng Jiang
🇨🇳Shanghai, Shanghai, China