Artificial Intelligence in Mental Illness Diagnosis and Treatment

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04515173
• Other study ID #: "Six zero zero"robot
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2021
• Source: Shanghai Mental Health Center
• Contact: Shanshan Su
• Phone: 17317126338
• Email: su.lingshan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Mental Disorders
• Mental Illness

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System sensitivity	The proportion that the system correctly determines people who are actually sick to be true.	Baseline
Primary	System specificity	The proportion that the system correctly determines people who are actually disease-free to be true negative.	Baseline
Primary	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
Primary	Recurrence rate	Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study	24 weeks
Secondary	Patients' satisfaction	The degree of patient satisfaction with the system	Baseline, 12 weeks, 24 weeks
Secondary	Clinical global impressions	The score of clinical global impressions scale(CGI)	Baseline, 12 weeks, 24 weeks
Secondary	Social function	The score of social disability screening schedule(SDSS)	Baseline, 12 weeks, 24 weeks
Secondary	Doctors' satisfaction	The degree of doctors' satisfaction with the system	Baseline, 12 weeks, 24 weeks