Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

Not Applicable

Recruiting

• Conditions: Amphetamine Addiction
• Interventions: Device: robot-assisted rehabilitation intelligent treatment; Other: standard psychotherapy treatment

• Registration Number: NCT04531384
• Lead Sponsor: Shanghai Mental Health Center

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.

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 Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Study Start: 2020-12-01
• Status Verified: 2022-09
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robot-assisted rehabilitation intelligent treatment	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.
treatment as usual	standard psychotherapy treatment	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.

Primary Outcome Measures

Name	Time	Method
Changes of galvanic skin response during the virtual reality based addiction assessment system	in 1 year	The galvanic skin response is an emotional physiological indicator, and its unit is ohm.

Secondary Outcome Measures

Name	Time	Method
Treatment motivation	in 1 year	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.
Reaction inhibition ability	in 1 year	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.
Anxiety	in 1 year	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.
Depression	in 1 year	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.
Attentional bias related to drugs and emotional stimulation	in 1 year	The emotional Stroop tests is used for assessed attentional bias. The indicator is the accuracy rate of the key presses, from 0 to 100%.
Risky decision-making	in 1 year	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.
Changes of electroencephalogram power spectrum during the virtual reality based addiction	in 1 year	The electroencephalogram power spectrum reflects the functional status of the brain, and its unit is uV\^2.

Trial Locations

Locations (1)

Shanghai Gaojing Rehabilitation Center; 🇨🇳 Shanghai, China