The Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With AUD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: robot-assisted rehabilitation intelligent treatment; Other: treatment as usual

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 23000
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Min Zhao, MD; Phone Number: 34289888-3193; Email: drminzhao@smhc.org.cn
      • Contact: Shuo Li, MA; Phone Number: +8613905536086; Email: ls520522@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: robot-assisted rehabilitation intelligent treatment; 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.	Device: robot-assisted rehabilitation intelligent treatment; Participants assigned to this condition were offered 10 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, and explaining CBT concepts). A robot therapist demonstrates the target CBT skills and assigns homework to participants. The treatment framework is semi-structured through human-computer interaction. The forms of interaction include inquiries, statements, recommendations summaries, and knowledge assessments.; Other: treatment as usual; Both groups will receive treatment as usual, including medication, exercise, and psychological education.
Other: treatment as usual; 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.	Other: treatment as usual; Both groups will receive treatment as usual, including medication, exercise, and psychological education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desire for alcohol	The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Readiness and Treatment Eagerness	The secondary outcome includes participants' Change Readiness and Treatment Eagerness, measured by the Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES).	3 months
Impulsiveness	The secondary outcome includes participants' level of impulsiveness, measured by the Barratt Impulsiveness Scale(Barratt).	3 months
Anxiety	The secondary outcome includes the participants' level of anxiety, measured by generalized Anxiety Disorder-7(GAD-7).	3 months
Depression	The secondary outcome includes the participants' level of depression, measured by Patient Health Questionnaire-9(PHQ-9).	3 months
Perception of stress	The secondary outcome includes participants' perception of stress, measured by the Perceived Stress Scale(PSS).	3 months
Sleep Quality	The secondary outcome includes participants' sleep quality, measured by Pittsburgh Sleep Quality Index(PSQI).	3 months
coping style	The secondary outcome includes participants' coping style, measured by Simplified Coping Style Questionnaire(SCSQ).	3 months
use of alcohol	The secondary outcome includes participants' use of alcohol.	3 months

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: MZhao-011

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