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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675553
• Other study ID #: MZhao-011
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desire for alcohol	The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).	3 months
Secondary	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
Secondary	Impulsiveness	The secondary outcome includes participants' level of impulsiveness, measured by the Barratt Impulsiveness Scale(Barratt).	3 months
Secondary	Anxiety	The secondary outcome includes the participants' level of anxiety, measured by generalized Anxiety Disorder-7(GAD-7).	3 months
Secondary	Depression	The secondary outcome includes the participants' level of depression, measured by Patient Health Questionnaire-9(PHQ-9).	3 months
Secondary	Perception of stress	The secondary outcome includes participants' perception of stress, measured by the Perceived Stress Scale(PSS).	3 months
Secondary	Sleep Quality	The secondary outcome includes participants' sleep quality, measured by Pittsburgh Sleep Quality Index(PSQI).	3 months
Secondary	coping style	The secondary outcome includes participants' coping style, measured by Simplified Coping Style Questionnaire(SCSQ).	3 months
Secondary	use of alcohol	The secondary outcome includes participants' use of alcohol.	3 months