Artificial Intelligence in Mental Illness Diagnosis and Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Artificial Intelligence; Mental Illness
• Intervention / Treatment: Diagnostic test: Artificial intelligence diagnosis and treatment assistance system

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 Type: Interventional
• Enrollment (Anticipated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shanshan Su; Phone Number: 17317126338; Email: su.lingshan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System sensitivity	The proportion that the system correctly determines people who are actually sick to be true.	Baseline
System specificity	The proportion that the system correctly determines people who are actually disease-free to be true negative.	Baseline
Cure rate	End of the period reached the total number of clinically cured patients / total number of all patients involved in the study	24 weeks
Recurrence rate	Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' satisfaction	The degree of patient satisfaction with the system	Baseline, 12 weeks, 24 weeks
Clinical global impressions	The score of clinical global impressions scale(CGI)	Baseline, 12 weeks, 24 weeks
Social function	The score of social disability screening schedule(SDSS）	Baseline, 12 weeks, 24 weeks
Doctors' satisfaction	The degree of doctors' satisfaction with the system	Baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Chair: Yifeng Xu, SMHC; Study Director: Jianyin QIU, SMHC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (ACTUAL): August 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: "Six zero zero"robot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No