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Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

NCT ID: NCT04531384

Last Updated: 2022-12-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.

Detailed Description

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Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.

Conditions

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Amphetamine Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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robot-assisted rehabilitation intelligent treatment

Participants assigned to this condition were offered 10 weekly individual sessions of robot-assisted rehabilitation treatment, delivered by the Robot-assisted rehabilitation intelligent system. The system contains 10 core cognitive-behavioral therapy (CBT) skill topics (such as functional analysis, coping skills training, reviewing practice exercises, explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants.

Group Type EXPERIMENTAL

robot-assisted rehabilitation intelligent treatment

Intervention Type DEVICE

robot-assisted rehabilitation psychotherapy

treatment as usual

Participants in the treatment-as-usual group were offered standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions, which consisted of weekly group and/or individual therapy, as determined by the clinical team.

Group Type OTHER

standard psychotherapy treatment

Intervention Type OTHER

standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions

Interventions

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robot-assisted rehabilitation intelligent treatment

robot-assisted rehabilitation psychotherapy

Intervention Type DEVICE

standard psychotherapy treatment

standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Zhao

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Gaojing Rehabilitation Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Zhao

Role: CONTACT

Phone: 64387250

Email: [email protected]

Facility Contacts

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Jianyan Dai

Role: primary

Other Identifiers

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MZhao-010

Identifier Type: -

Identifier Source: org_study_id