Back to resultsRobot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.
Primary Purpose
Amphetamine Addiction
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
robot-assisted rehabilitation intelligent treatment
standard psychotherapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine Addiction
Eligibility Criteria
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.
Sites / Locations
- Shanghai Gaojing Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
robot-assisted rehabilitation intelligent treatment
treatment as usual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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%.
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.
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.
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.
Full Information
NCT ID
NCT04531384
First Posted
August 4, 2020
Last Updated
December 28, 2022
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04531384
Brief Title
Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.
Official Title
Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robot-assisted rehabilitation intelligent treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
treatment as usual
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
robot-assisted rehabilitation intelligent treatment
Intervention Description
robot-assisted rehabilitation psychotherapy
Intervention Type
Other
Intervention Name(s)
standard psychotherapy treatment
Intervention Description
standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions
Primary Outcome Measure Information:
Title
Changes of galvanic skin response during the virtual reality based addiction assessment system
Description
The galvanic skin response is an emotional physiological indicator, and its unit is ohm.
Time Frame
in 1 year
Secondary Outcome Measure Information:
Title
Treatment motivation
Description
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.
Time Frame
in 1 year
Title
Anxiety
Description
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.
Time Frame
in 1 year
Title
Depression
Description
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.
Time Frame
in 1 year
Title
Attentional bias related to drugs and emotional stimulation
Description
The emotional Stroop tests is used for assessed attentional bias. The indicator is the accuracy rate of the key presses, from 0 to 100%.
Time Frame
in 1 year
Title
Risky decision-making
Description
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.
Time Frame
in 1 year
Title
Reaction inhibition ability
Description
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.
Time Frame
in 1 year
Title
Changes of electroencephalogram power spectrum during the virtual reality based addiction
Description
The electroencephalogram power spectrum reflects the functional status of the brain, and its unit is uV^2.
Time Frame
in 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Zhao
Phone
64387250
Email
drminzhao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zhao
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Gaojing Rehabilitation Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyan Dai
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.
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