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Clinical Trials/NCT05675553
NCT05675553RecruitingNot Applicable

A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders

Shanghai Mental Health Center1 site in 1 country100 target enrollmentStarted: June 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Desire for alcohol

Study Overview

Brief Summary

We aimed to test the efficacy of robot-assisted intelligent rehabilitation treatment in patients with alcohol use disorders with a randomized controlled trial. Specifically, the objective of this trial is to determine whether the robot-assisted intelligent rehabilitation treatment plus treatment as usual has greater efficacy than traditional therapy in the treatment of alcohol use disorders.

Detailed Description

Based on artificial intelligence technology, face recognition technology, and 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 patients with alcohol use disorders, and compare with traditional treatment to verify the efficacy and safety of the Robot-assisted rehabilitation intelligent system in Chinese patients with alcohol use disorders.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Between the ages of 18-55;
  • Meeting DSM-5 criteria for alcohol use disorders;
  • Withdrawing alcohol for less than 12 months;
  • Ability to use computers;
  • Signing informed consent;

Exclusion Criteria

  • Having comorbidities of other neuropsychiatric diseases;
  • Diseases that affect cognitive function, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
  • With a family history of mental illness
  • Not familiar with computer operation, unable to complete assessment and treatment.

Arms & Interventions

robot-assisted rehabilitation intelligent treatment

Experimental

Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise, and psychotherapy. Robot-assisted intelligent rehabilitation treatment will be delivered to participants in the testing group through an addiction prevention and relapse intervention intelligent system.

Intervention: robot-assisted rehabilitation intelligent treatment (Device)

treatment as usual

Other

Participants in the treatment-as-usual group were offered standard treatment at the mental health hospitals, which consisted of group and/or individual therapy, as determined by the clinical team.

Intervention: treatment as usual (Other)

robot-assisted rehabilitation intelligent treatment

Experimental

Both groups will receive treatment as usual(TAU) provided by the clinical team, including medication, exercise, and psychotherapy. Robot-assisted intelligent rehabilitation treatment will be delivered to participants in the testing group through an addiction prevention and relapse intervention intelligent system.

Intervention: treatment as usual (Other)

Outcomes

Primary Outcomes

Desire for alcohol

Time Frame: 3 months

The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).

Secondary Outcomes

  • Anxiety(3 months)
  • Change Readiness and Treatment Eagerness(3 months)
  • Impulsiveness(3 months)
  • Depression(3 months)
  • Perception of stress(3 months)
  • Sleep Quality(3 months)
  • coping style(3 months)
  • use of alcohol(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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