NCT04515173

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

August 13, 2020

Last Update Submit

March 17, 2021

Conditions

Artificial IntelligenceMental Illness

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Patients' satisfaction

    Baseline, 12 weeks, 24 weeks

  • Clinical global impressions

    Baseline, 12 weeks, 24 weeks

  • Social function

    Baseline, 12 weeks, 24 weeks

  • Doctors' satisfaction

    Baseline, 12 weeks, 24 weeks

Study Arms (2)

Artificial intelligence group

EXPERIMENTAL

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

General group

OTHER

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

Artificial intelligence diagnosis and treatment assistance systemDIAGNOSTIC_TEST

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

Artificial intelligence groupGeneral group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Yifeng Xu

    SMHC

    STUDY CHAIR

  • Jianyin QIU

    SMHC

    STUDY DIRECTOR

Central Study Contacts

Shanshan Su

CONTACT

17317126338su.lingshan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The director of the hospital

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

April 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

March 22, 2021

Record last verified: 2021-03