Artificial Intelligence in Mental Illness Diagnosis and Treatment

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04515173
Collaborator
(none)
4,000
2
32

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Artificial intelligence diagnosis and treatment assistance system
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Artificial Intelligence for Enhancing the Diagnosis and Treatment of Mental Illness:a Prospective, Randomized Controlled Multicenter Clinical Trail
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Artificial intelligence group

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.

Diagnostic Test: Artificial intelligence diagnosis and treatment assistance system
An artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up.

Other: General group

The subjects in this group only received routine drug therapy and routine outpatient follow-up evaluation

Diagnostic Test: Artificial intelligence diagnosis and treatment assistance system
An artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up.

Outcome Measures

Primary Outcome Measures

  1. System sensitivity [Baseline]

    The proportion that the system correctly determines people who are actually sick to be true.

  2. System specificity [Baseline]

    The proportion that the system correctly determines people who are actually disease-free to be true negative.

  3. Cure rate [24 weeks]

    End of the period reached the total number of clinically cured patients / total number of all patients involved in the study

  4. Recurrence rate [24 weeks]

    Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study

Secondary Outcome Measures

  1. Patients' satisfaction [Baseline, 12 weeks, 24 weeks]

    The degree of patient satisfaction with the system

  2. Clinical global impressions [Baseline, 12 weeks, 24 weeks]

    The score of clinical global impressions scale(CGI)

  3. Social function [Baseline, 12 weeks, 24 weeks]

    The score of social disability screening schedule(SDSS)

  4. Doctors' satisfaction [Baseline, 12 weeks, 24 weeks]

    The degree of doctors' satisfaction with the system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

  • Study Chair: Yifeng Xu, SMHC
  • Study Director: Jianyin QIU, SMHC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yifeng XU, The director of the hospital, Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT04515173
Other Study ID Numbers:
  • "Six zero zero"robot
First Posted:
Aug 17, 2020
Last Update Posted:
Mar 22, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2021