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Clinical Trials/NCT04515173
NCT04515173
Unknown
Not Applicable

Artificial Intelligence for Enhancing the Diagnosis and Treatment of Mental Illness:a Prospective, Randomized Controlled Multicenter Clinical Trail

Shanghai Mental Health Center0 sites4,000 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Artificial Intelligence
Sponsor
Shanghai Mental Health Center
Enrollment
4000
Primary Endpoint
System sensitivity
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 1, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yifeng XU

The director of the hospital

Shanghai Mental Health Center

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.

Outcomes

Primary Outcomes

System sensitivity

Time Frame: Baseline

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

System specificity

Time Frame: Baseline

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

Recurrence rate

Time Frame: 24 weeks

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

Cure rate

Time Frame: 24 weeks

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

Secondary Outcomes

  • Patients' satisfaction(Baseline, 12 weeks, 24 weeks)
  • Clinical global impressions(Baseline, 12 weeks, 24 weeks)
  • Doctors' satisfaction(Baseline, 12 weeks, 24 weeks)
  • Social function(Baseline, 12 weeks, 24 weeks)

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