Artificial Intelligence in Mental Illness Diagnosis and Treatment
Primary Purpose
Artificial Intelligence, Mental Illness
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Artificial intelligence diagnosis and treatment assistance system
Sponsored by

About this trial
This is an interventional treatment trial for Artificial Intelligence
Eligibility Criteria
Inclusion Criteria:
- Community high-risk groups and institutional groups.
- According to the ICD-11 diagnostic guidelines of anxiety-related disorders, depression-related disorders, addiction-related disorders, compulsive-related disorders diagnosis,
- age 18-60 years old,
- skilled in the operation of computers or smartphones,
- language, reading ability is normal,
- willing to participate in the project and sign informed consent study.
Exclusion Criteria:
- The symptoms of mental illness are severe and require hospitalization, or the patient is unable to complete the required assessment examination and treatment.
- Those who have a higher risk of self-injury or suicide.
- People with severe physical illness, central system disease, or substance abuse.
- Receive physical therapy at the same time.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Artificial intelligence group
General group
Arm Description
On the basis of conventional drug therapy combined with psychotherapy robot psychotherapy, the corresponding intelligent psychotherapy module and intensity were recommended according to the results of intelligent psychological evaluation. Each module was set once a week, 50 minutes each time, a total of 12 times.
The subjects in this group only received routine drug therapy and routine outpatient follow-up evaluation
Outcomes
Primary Outcome Measures
System sensitivity
The proportion that the system correctly determines people who are actually sick to be true.
System specificity
The proportion that the system correctly determines people who are actually disease-free to be true negative.
Cure rate
End of the period reached the total number of clinically cured patients / total number of all patients involved in the study
Recurrence rate
Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study
Secondary Outcome Measures
Patients' satisfaction
The degree of patient satisfaction with the system
Clinical global impressions
The score of clinical global impressions scale(CGI)
Social function
The score of social disability screening schedule(SDSS)
Doctors' satisfaction
The degree of doctors' satisfaction with the system
Full Information
NCT ID
NCT04515173
First Posted
August 13, 2020
Last Updated
March 17, 2021
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04515173
Brief Title
Artificial Intelligence in Mental Illness Diagnosis and Treatment
Official Title
Artificial Intelligence for Enhancing the Diagnosis and Treatment of Mental Illness:a Prospective, Randomized Controlled Multicenter Clinical Trail
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To improve the quality of mental health services, we will develop a robot that includes disease screening, diagnosis, treatment, and follow-up. The effectiveness of robots will be verified in a prospective, randomized, multi-center clinical trial. We assume that the robot will reduce the differences in the experience of doctors of different years and will improve mental health care across the country, and improve the uneven distribution of mental health resources through remote resource sharing.
Detailed Description
Anxiety disorder is the most common mental disorder in the world. The lifetime prevalence of anxiety disorder in China is as high as 7.6%, but the treatment rate is less than 30%, and the standard treatment rate is only 9.8%. The disease burden is heavy, and it is one of the most serious public health problems in China. Anxiety disorder is a chronic relapsing disease, single drug treatment only 35-50% efficient, psychological treatment as the most international evidence-based foundation and anxiety disorder most commonly used treatment method, can be a single treatment for anxiety disorders or improve the effect of the medication, but because of clinical psychology in China started late, the lack of professionals, unable to meet the huge demand for psychological treatment in our country, therefore, how to develop efficient and standardized anxiety disorders psychotherapy pattern, improve the psychological treatment of acquired, is the key to improve the clinical curative effect of anxiety disorders. Based on the intelligent assisted psychotherapy system based on cognitive behavior and mindfulness developed in the early stage, this research group established the accurate psychotherapy artificial intelligence robot based on evaluation to assist the whole process of standardized psychotherapy for anxiety disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Intelligence, Mental Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Artificial intelligence group
Arm Type
Experimental
Arm Description
On the basis of conventional drug therapy combined with psychotherapy robot psychotherapy, the corresponding intelligent psychotherapy module and intensity were recommended according to the results of intelligent psychological evaluation. Each module was set once a week, 50 minutes each time, a total of 12 times.
Arm Title
General group
Arm Type
Other
Arm Description
The subjects in this group only received routine drug therapy and routine outpatient follow-up evaluation
Intervention Type
Diagnostic Test
Intervention Name(s)
Artificial intelligence diagnosis and treatment assistance system
Intervention Description
An artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up.
Primary Outcome Measure Information:
Title
System sensitivity
Description
The proportion that the system correctly determines people who are actually sick to be true.
Time Frame
Baseline
Title
System specificity
Description
The proportion that the system correctly determines people who are actually disease-free to be true negative.
Time Frame
Baseline
Title
Cure rate
Description
End of the period reached the total number of clinically cured patients / total number of all patients involved in the study
Time Frame
24 weeks
Title
Recurrence rate
Description
Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Patients' satisfaction
Description
The degree of patient satisfaction with the system
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Clinical global impressions
Description
The score of clinical global impressions scale(CGI)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Social function
Description
The score of social disability screening schedule(SDSS)
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Doctors' satisfaction
Description
The degree of doctors' satisfaction with the system
Time Frame
Baseline, 12 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Community high-risk groups and institutional groups.
According to the ICD-11 diagnostic guidelines of anxiety-related disorders, depression-related disorders, addiction-related disorders, compulsive-related disorders diagnosis,
age 18-60 years old,
skilled in the operation of computers or smartphones,
language, reading ability is normal,
willing to participate in the project and sign informed consent study.
Exclusion Criteria:
The symptoms of mental illness are severe and require hospitalization, or the patient is unable to complete the required assessment examination and treatment.
Those who have a higher risk of self-injury or suicide.
People with severe physical illness, central system disease, or substance abuse.
Receive physical therapy at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanshan Su
Phone
17317126338
Email
su.lingshan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifeng Xu
Organizational Affiliation
SMHC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jianyin QIU
Organizational Affiliation
SMHC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Artificial Intelligence in Mental Illness Diagnosis and Treatment
We'll reach out to this number within 24 hrs