The Novel Addiction Assessment Study in Synthetic Drugs Addiction
6 januari 2020 uppdaterad av: Min ZHAO, Shanghai Mental Health Center
Development of Virtual Reality-Based Addiction Assessment System for Synthetic Drugs Addiction
The purpose of this research is to develop an objective assessment based on the virtual reality techniques which is used for evaluate addiction severity.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
In order to evaluate the addiction severity and the effect of rehabilitation objectively, this study develops a virtual environment model based on the virtual reality technique, making the subjects in a drug related or neutral scene , at the same time recording the physical signs and eye movements index.
Reliability and validity of this system will also be tested in this study.
And we will construct the norm of addiction assessment system in Shanghai .The evaluating system will be very beneficial to develop novel and practical assessment for synthetic durg related disorder, and provide a reference for other drug dependence diagnosis.
Studietyp
Observationell
Inskrivning (Faktisk)
1500
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Shanghai
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Shanghai, Shanghai, Kina
- Shanghai Mental Health Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
The study includes the synthetic drug abusers and healthy control into the experiment.The drug abusers will be recruited from compulsory isolated detoxification centers and non compulsory isolated detoxification institutions.The healthy control will be recruited from the residential communities.
Beskrivning
Criteria for synthetic drug abusers:
Inclusion Criteria:
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-4) for methamphetamine (MA) use disorders;
- Education level equal or more than 9 years;
- Have normal or corrected-to-normal vision;
- Have normal or corrected-to-normal hearing;
- Less than 3 months before last drug use;
Exclusion Criteria:
- Current substance use (except nicotine or caffeine) ;
- History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、 head injury or other severe medication conditions;
- Intelligence quotient less than 70.
Criteria for healthy control:
Inclusion Criteria:
- Without schizophrenia family history;
- Without history of drug abuse;
- Education level equal or more than 9 years;
- Have normal or corrected-to-normal vision;
- Have normal or corrected-to-normal hearing.
Exclusion Criteria:
- History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
- Intelligence quotient less than 70.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Group1：amphetamine abusers
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The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity.
And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the beginning of withdrawl、3 months later、 6 months later and 1 year later and record the information synchronously.
The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity.
And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.In this group which is designed to construct the norm of assessment system, the test will record the information synchronously and proceed after baseline assessment.
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Group2: health control
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The healthy controls will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the baseline and 1 month later and record the information synchronously.
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Group3: norm of assessment system
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The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity.
And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the beginning of withdrawl、3 months later、 6 months later and 1 year later and record the information synchronously.
The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity.
And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.In this group which is designed to construct the norm of assessment system, the test will record the information synchronously and proceed after baseline assessment.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes of physiological indexs
Tidsram: In 1 year
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The physiological index including galvanic skin response、encephlogram and electromyogram will be used to evaluate the reliability and validity of the virtual reality based addiction assessment system, and construct the norms of assessment system as well.
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In 1 year
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Changes of eye movement index
Tidsram: In 1 year
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The eye movement index will be used to evaluate the reliability and validity of the virtual reality based addiction assessment system, and construct the norms of assessment system as well.
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In 1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Diagnostic and Statistical Manual of Mental Disorders（DSM）
Tidsram: baseline
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To establish the criterion validity
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baseline
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Addiction Severity Index(ASI)
Tidsram: baseline
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To establish the criterion validity
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baseline
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Min Zhao, PhD, Shanghai Mental Health Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2016
Primärt slutförande (Faktisk)
1 december 2018
Avslutad studie (Faktisk)
1 december 2018
Studieregistreringsdatum
Först inskickad
23 oktober 2016
Först inskickad som uppfyllde QC-kriterierna
27 oktober 2016
Första postat (Uppskatta)
1 november 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MZhao-006
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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