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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Device: robot-assisted rehabilitation intelligent treatment; Other: treatment as usual

• Registration Number: NCT05675553
• Lead Sponsor: Shanghai Mental Health Center

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 Timeline

• Study Start: 2022-06-15
• Status Verified: 2022-12
• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2022-12-28
• Last Update Submitted: 2022-12-28
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Desire for alcohol	3 months	The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China