Artificial IntelligenceNCT04515173
Artificial Intelligence in Mental Illness Diagnosis and Treatment
A study testing Artificial intelligence diagnosis and treatment assistance system in people with Artificial Intelligence and Mental Illness, run by Shanghai Mental Health Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Artificial Intelligence, Mental Illness
- What is being tested?
- Artificial intelligence diagnosis and treatment assistance system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Artificial Intelligence, Mental Illness
- Being tested
- Artificial intelligence diagnosis and treatment assistance system
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence diagnosis and treatment assistance systemDiagnostic test
An artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Diagnostic Test: Artificial intelligence diagnosis and treatment assistance system |
What is being measured
The primary outcome is the main question the study is designed to answer.
System sensitivity
The proportion that the system correctly determines people who are actually sick to be true.
Measured: Baseline
System specificity
The proportion that the system correctly determines people who are actually disease-free to be true negative.
Measured: Baseline
Cure rate
End of the period reached the total number of clinically cured patients / total number of all patients involved in the study
Measured: 24 weeks
Recurrence rate
Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study
Measured: 24 weeks
Secondary outcomes (4)
Patients' satisfaction
The degree of patient satisfaction with the system
Measured: Baseline, 12 weeks, 24 weeks
Clinical global impressions
The score of clinical global impressions scale(CGI)
Measured: Baseline, 12 weeks, 24 weeks
Social function
The score of social disability screening schedule(SDSS）
Measured: Baseline, 12 weeks, 24 weeks
Doctors' satisfaction
The degree of doctors' satisfaction with the system
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng XU, Shanghai Mental Health Center
- Investigators
- Yifeng Xu, Study chair, SMHCJianyin QIU, Study director, SMHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515173
- Sponsor's protocol ID
- "Six zero zero"robot
- Status last verified
- Mar 2021
- First submitted
- 13 Aug 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Enhancing the Diagnosis and Treatment of Mental Illness：a Prospective, Randomized Controlled Multicenter Clinical Trail
- ClinicalTrials.gov ID
- NCT04515173
- Acronym / sponsor ID
- "Six zero zero"robot
- Conditions
- Artificial Intelligence, Mental Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence group | Experimental | Diagnostic Test: Artificial intelligence diagnosis and treatment assistance systemOn 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. |
| General group | Other | Diagnostic Test: Artificial intelligence diagnosis and treatment assistance systemThe subjects in this group only received routine drug therapy and routine outpatient follow-up evaluation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial intelligence diagnosis and treatment assistance systemAn artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up. | Diagnostic test | Artificial intelligence group, General group |
Primary outcome
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.
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
Recurrence rate
Time frame: 24 weeks
Total number of patients with recurrence or recurrence of symptoms/total number of patients involved in the study
4 secondary outcomes
Patients' satisfaction
Time frame: Baseline, 12 weeks, 24 weeks
Clinical global impressions
Time frame: Baseline, 12 weeks, 24 weeks
Social function
Time frame: Baseline, 12 weeks, 24 weeks
Doctors' satisfaction
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yifeng Xu study chair
SMHC
Jianyin QIU study director
SMHC
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence diagnosis and treatment assistance system in people with Artificial Intelligence and Mental Illness, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Su (17317126338, su.lingshan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System sensitivity (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.