UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049505 |
|---|---|
| Receipt number | R000056374 |
| Scientific Title | Development of Depressive Symptom Assessment Techniques Using Multimodal AI Video Analysis of Web Interviews |
| Date of disclosure of the study information | 2022/11/18 |
| Last modified on | 2022/11/18 11:37:55 |
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Basic information
Public title
Research on Detection of Depression by Multimodal AI Video Analysis
Acronym
Research on Detection of Depression by Multimodal AI Video Analysis
Scientific Title
Development of Depressive Symptom Assessment Techniques Using Multimodal AI Video Analysis of Web Interviews
Scientific Title:Acronym
Development of Depressive Symptom Assessment Techniques Using Multimodal AI Video Analysis of Web Interviews
Region
| Japan |
Condition
Condition
Depressive Symptom
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
n this study, free conversation and mood assessment interviews will be conducted using a web conferencing system with persons who may have depressive symptoms, etc. The purpose of this study is to develop a technique for assessing depressive symptoms using a multimodal AI video analysis technique. The purpose of this study is to develop a technology for evaluating depressive symptoms by using multimodal AI video analysis technology for voice, facial expression, and text data acquired during these interviews.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Presence of psychiatric disorders: depressive episodes according to SCID-5
Key secondary outcomes
Severity assessment: MADRS, PHQ-9
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. those who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study fully, volunteer to participate of their own free will, and agree in writing to participate in the study
2. those who are at least 18 years of age at the time of consent
3. those who are healthy or have depressive symptoms and are already receiving counseling services or will receive counseling services in the future
4. those who have a smart phone or PC and can use web conferencing via the Internet.
Key exclusion criteria
1. those whose condition is likely to be impaired by participation in this study
2. who are deemed inappropriate by the principal investigator or co-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nose |
Organization
I'm beside you Inc.
Division name
Chief Technology Officer
Zip code
1056415
Address
Toranomon Hills Business Tower 12 floor, Toranomon1-17-1, Minato-ku Tokyo
TEL
070-4368-4330
yasuhironose@imbesideyou.world
Public contact
Name of contact person
| 1st name | Yuna |
| Middle name | |
| Last name | Nango |
Organization
I'm beside you Inc.
Division name
Chief Customer Success Officer
Zip code
1056415
Address
Toranomon Hills Business Tower 12 floor, Toranomon1-17-1, Minato-ku Tokyo
TEL
070-4368-4330
Homepage URL
https://prtimes.jp/main/html/rd/p/000000043.000066162.html
yunanango@imbesideyou.world
Sponsor or person
Institute
I'm beside you Inc.
Institute
Department
Personal name
Funding Source
Organization
I'm beside you Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Healthcare Systems Co., Ltd.
Address
Shirokane 1-14-18, Showa-Ku, Nagoya-City, Aichi
Tel
03-6809-2722
info@hc-sys.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社I'mbesideyou（東京都）/ I’m beside you Inc.（Tokyo）
オンラインによる面談/Online interview
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational Studies
Randomization: Single arm
Blinding: Open-label
Control: Uncontrolled
Allocation: Not conducted
Method of recruitment
Candidates who met the selection criteria will be selected from among the registered members of cotree, an online counseling service provider (collaborating organization), via the Web and e-mail newsletter (October-November 2022), so that there will be no bias in terms of gender, working status, etc.
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056374
