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

September 13, 2021 updated by: Haifeng Jiang, Shanghai Mental Health Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Haifeng Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: 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.
ACTIVE_COMPARATOR: Community-based rehabilitation group
Participants will receive the standardized community-based rehabilitation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug urine test
Time Frame: 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).
Up to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interacting with anti-drug social workers
Time Frame: 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.
Up to six months
The decrease rate of addiction-related issues severity index
Time Frame: 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.
Up to six months
Longest duration of sustained abstinence
Time Frame: 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).
Up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: Haifeng Jiang, Doctor, Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

February 24, 2018

First Posted (ACTUAL)

March 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFJiang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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