Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

NCT04531384 | Unknown

• 1 other identifier: MZhao-010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amphetamine Addiction

Outcome Measures

Primary Outcomes (1)

• Changes of galvanic skin response during the virtual reality based addiction assessment system

  The galvanic skin response is an emotional physiological indicator, and its unit is ohm.

  in 1 year

Secondary Outcomes (7)

• Treatment motivation

  in 1 year

• Anxiety

  in 1 year

• Depression

  in 1 year

• Attentional bias related to drugs and emotional stimulation

  in 1 year

• Risky decision-making

  in 1 year

Study Arms (2)

robot-assisted rehabilitation intelligent treatment

EXPERIMENTAL

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.

Device: robot-assisted rehabilitation intelligent treatment

treatment as usual

OTHER

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.

Other: standard psychotherapy treatment

Interventions

robot-assisted rehabilitation intelligent treatment DEVICE

robot-assisted rehabilitation psychotherapy

robot-assisted rehabilitation intelligent treatment

standard psychotherapy treatment OTHER

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

treatment as usual

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Gaojing Rehabilitation Center

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Min Zhao

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Zhao

CONTACT

64387250; drminzhao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 28, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)