CClinicalTrials.gg
Status unknownNCT04515173Updated Mar 22, 2021

Artificial Intelligence in Mental Illness Diagnosis and Treatment

An interventional study of Artificial intelligence diagnosis and treatment assistance system in Artificial Intelligence and Mental Illness, sponsored by Shanghai Mental Health Center. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
4,000
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Artificial Intelligence
  • Mental Illness

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03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,000 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Diagnostic testArtificial intelligence diagnosis and treatment assistance system

    An artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up.

06

What researchers measure

Primary outcomes

  1. System sensitivity

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

    Time frame: Baseline

  2. System specificity

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

    Time frame: Baseline

  3. Cure rate

    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

  4. Recurrence rate

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

    Time frame: 24 weeks

Secondary outcomes

  1. Patients' satisfaction

    The degree of patient satisfaction with the system

    Time frame: Baseline, 12 weeks, 24 weeks

  2. Clinical global impressions

    The score of clinical global impressions scale(CGI)

    Time frame: Baseline, 12 weeks, 24 weeks

  3. Social function

    The score of social disability screening schedule(SDSS)

    Time frame: Baseline, 12 weeks, 24 weeks

  4. Doctors' satisfaction

    The degree of doctors' satisfaction with the system

    Time frame: Baseline, 12 weeks, 24 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04515173
Lead sponsor
Shanghai Mental Health Center
Responsible party
Yifeng XU (The director of the hospital, Shanghai Mental Health Center) — Principal investigator
First posted
Aug 17, 2020
Start date
Apr 1, 2021 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Mar 22, 2021

Study contacts

Shanshan Su
Contact
su.lingshan@163.com
17317126338
Yifeng Xu
study chair · SMHC
Jianyin QIU
study director · SMHC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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