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Clinical Trials/NCT04531384
NCT04531384RecruitingNot Applicable

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

Shanghai Mental Health Center1 site in 1 country200 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Changes of galvanic skin response during the virtual reality based addiction assessment system

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: robot-assisted rehabilitation intelligent treatment (Device)

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.

Intervention: standard psychotherapy treatment (Other)

Outcomes

Primary Outcomes

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

Time Frame: in 1 year

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

Secondary Outcomes

  • Treatment motivation(in 1 year)
  • Reaction inhibition ability(in 1 year)
  • Attentional bias related to drugs and emotional stimulation(in 1 year)
  • Risky decision-making(in 1 year)
  • Anxiety(in 1 year)
  • Depression(in 1 year)
  • Changes of electroencephalogram power spectrum during the virtual reality based addiction(in 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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