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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
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Artificial Intelligence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 13, 2020
    Last Updated
    March 17, 2021
    Sponsor
    Shanghai Mental Health Center
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    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

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