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

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
robot-assisted rehabilitation intelligent treatment
treatment as usual
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

robot-assisted rehabilitation intelligent treatment

treatment as usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2022
Last Updated
December 28, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05675553
Brief Title
The Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With AUD
Official Title
A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
robot-assisted rehabilitation intelligent treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
treatment as usual
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
robot-assisted rehabilitation intelligent treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
treatment as usual
Intervention Description
Both groups will receive treatment as usual, including medication, exercise, and psychological education.
Primary Outcome Measure Information:
Title
Desire for alcohol
Description
The primary outcome is patients' desire for alcohol,measured by Visual Analogue Scale(VAS).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change Readiness and Treatment Eagerness
Description
The secondary outcome includes participants' Change Readiness and Treatment Eagerness, measured by the Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES).
Time Frame
3 months
Title
Impulsiveness
Description
The secondary outcome includes participants' level of impulsiveness, measured by the Barratt Impulsiveness Scale(Barratt).
Time Frame
3 months
Title
Anxiety
Description
The secondary outcome includes the participants' level of anxiety, measured by generalized Anxiety Disorder-7(GAD-7).
Time Frame
3 months
Title
Depression
Description
The secondary outcome includes the participants' level of depression, measured by Patient Health Questionnaire-9(PHQ-9).
Time Frame
3 months
Title
Perception of stress
Description
The secondary outcome includes participants' perception of stress, measured by the Perceived Stress Scale(PSS).
Time Frame
3 months
Title
Sleep Quality
Description
The secondary outcome includes participants' sleep quality, measured by Pittsburgh Sleep Quality Index(PSQI).
Time Frame
3 months
Title
coping style
Description
The secondary outcome includes participants' coping style, measured by Simplified Coping Style Questionnaire(SCSQ).
Time Frame
3 months
Title
use of alcohol
Description
The secondary outcome includes participants' use of alcohol.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
23000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Zhao, MD
Phone
34289888-3193
Email
drminzhao@smhc.org.cn
First Name & Middle Initial & Last Name & Degree
Shuo Li, MA
Phone
+8613905536086
Email
ls520522@sjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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