Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Amphetamine Addiction
• Intervention / Treatment: Device: robot-assisted rehabilitation intelligent treatment; Other: standard psychotherapy treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Zhao; Phone Number: 64387250; Email: drminzhao@gmail.com

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Gaojing Rehabilitation Center
    • Contact: Jianyan Dai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: robot-assisted rehabilitation intelligent treatment; robot-assisted rehabilitation psychotherapy
Other: 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.	Other: standard psychotherapy treatment; standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment motivation	Using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) to measure the treatment motivation of the participants. The score of the scale is between 19 and 95. The higher the score, the higher the treatment motivation.	in 1 year
Anxiety	Anxiety is assessed by the State-Trait Anxiety Scale (SAS). The score of the SAS scale is between 0 and 80. The higher the score, the more severe the anxiety symptoms.	in 1 year
Depression	Depression is assessed by the the Beck Depression Scale (SDS). The score of the SDS scale is between 0 and 80. The higher the score, the more severe the depression symptoms.	in 1 year
Attentional bias related to drugs and emotional stimulation	The emotional Stroop tests is used for assessed attentional bias. The indicator is the accuracy rate of the key presses, from 0 to 100%.	in 1 year
Risky decision-making	Balloon Analogue Risk Task is used for assess the risky decision-making ability. The indicator is the average number of balloon blows, and its unit is times.	in 1 year
Reaction inhibition ability	Stop signal task is used for assess the reaction inhibition ability. The indicator is the reaction time when the participant completes the task, and its unit is milliseconds.	in 1 year
Changes of electroencephalogram power spectrum during the virtual reality based addiction	The electroencephalogram power spectrum reflects the functional status of the brain, and its unit is uV^2.	in 1 year

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Min Zhao, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Amphetamine-Related Disorders
• Other Study ID Numbers: MZhao-010

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