UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047479 |
|---|---|
| Receipt number | R000050575 |
| Scientific Title | Online mental health care system construction and effect verification in response to social changes caused by COVID-19 |
| Date of disclosure of the study information | 2022/04/13 |
| Last modified on | 2023/10/02 14:58:50 |
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Basic information
Public title
Online mental health care system construction
Acronym
OHSYS
Scientific Title
Online mental health care system construction and effect verification in response to social changes caused by COVID-19
Scientific Title:Acronym
OHSYS
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct an online consulting system for the citizens who are in need for mental health care services, and to verify its validity and usefulness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change in the score of depression from baseline to the 1-month endpoint, assessed by the PHQ-9 (Patient Health Questionnaire-9)
Key secondary outcomes
1.changes in the scores of anxiety, insomnia, and mental health QOL from baseline to the 1-month endpoint, assessed by the GAD-7 (Generalized Anxiety Disorder-7), ISI (Insomnia Severity Index), and EQ-5D-5L (EuroQOL-5 Dimension-5 Level), respectively
2.observance ratio in compliance with the results of triage provided by this system
3. satisfaction ratio of the users
4. ratio of persons receiving appropriate treatments by medical institutions through the participation of this system
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
For less than mild case, no treatment (follow-up examination at 1-month endpoint only)
Interventions/Control_2
For mild case, recommendation for using the "Kokoro conditioner", a chatbot application based on the ideas of CBT (Cognitive and Behavioral Therapy)
Interventions/Control_3
For moderate and severe case, recommendation for applying for the online repid PFA program (Psychological First Aid) or SNS counselling provided by Tokyo Mentalhealth Square
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects are limited to :
1) those who are junior high school students and older; and
2) those who are setteled either in the Tokyo Metropolitan area, Tokorozawa City, Kawaguchi City, Yokohama City, Chiba City, Shizuoka City, Nagoya City, Toyota City, Kyoto City, Osaka City, Yonago City, or Fukuoka City, Shinsiro City, Sendai City, Kooriyama City, and/or those commuting to work or school in these areas.
Key exclusion criteria
Subjects who are not allowed to enter are:
1) those who are already receiving medical treatment for mental health problems; and
2) those who are in the 6th grade of elementary school or younger.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Nakagome |
Organization
National Center of Neurology and Psychiatry
Division name
President
Zip code
1878551
Address
4-1-1 Ogawa Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
0423412711
nakagome@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Fumikazu |
| Middle name | |
| Last name | Hiyoshi |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Clinical Psychology
Zip code
1878551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
0423412711
Homepage URL
kokorobo@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Science and Technology Agency
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
Tel
0423412711
ml_rinrijimu@ncnp.go.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
国立研究開発法人国立精神・神経医療研究センター（東京都）、学校法人慶應義塾（東京都）、国立大学法人九州大学（福岡県）、杏林大学（東京都）、横浜市立大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 13 | 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
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050575
