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Japanese

Oct. 31, 2023

Oct. 28, 2024

jRCT1032230427

A pilot study for an intervention study using AI chatbot-based cognitive behavioural therapy for depressed child and adolescent in waiting list. (None)

None (None)

Fujita Junichi

Yokohama City University Hospital

3-9, Fukuura, Kanazawa-ku, Yokohama

+81-457872800

jun1182@yokohama-cu.ac.jp

Mio Ishii

Yokohama City University

3-9, Fukuura, Kanazawa-ku, Yokohama

+81-457872800

t126012f@yokohama-cu.ac.jp

Suspended

Oct. 16, 2023

Dec. 08, 2023
60

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

health services research

(1) Age between 12 and 18 years old at the time of registration
(2) Person on the waiting list at the Department of Child Psychiatry, Yokohama City University Hospital
(3) Persons with self-administered depression rating scale PHQ-9>=10 (moderate or higher depression)
(4) Persons who have a terminal environment that can run the mental self-care application "emol".
(5) Those who are able to use Zoom for online interviewing
(6) Those who have no difficulty in reading and writing Japanese at the upper elementary school level.
(7) Those who can agree not to use other mental self-care applications.
(8) Persons who can obtain written or electromagnetic consent from their parents or guardians and the research subjects to te in this stuparticipady.

(1) Those with a high degree of urgency as judged by a child psychiatrist (those deemed appropriate to be seen within 8 weeks)
(2) Those who have reported suicide attempts within the past 2 weeks on the medical questionnaire.
(3) Those who have anorexia and have an imminent need for physical treatment.
(4) No plans for psychiatric consultation or counseling during the intervention period.
(5) Those who continue to take psychotropic drugs prescribed by the above-mentioned medical institutions.
(6) Those who have difficulty in keeping a daily log due to an injury to their dominant hand.
(7) Other persons who are judged to be unsuitable for the program by the physician.

12age old over
18age old not

Both

depressive states

Regular online assessments once every 2 weeks, provision of mental health information on the website, and cognitive behavioral therapy intervention with emol once a week for a total of 8 sessions

Change in PHQ-9 before and after intervention

Correlation and relevance to the primary endpoints will be assessed in the following secondary endpoints
AIS,Analyzed data of voiceprint,Analyzed data of strength needed to write

None
FY2022-2031 Japan Science and Technology Agency (JST) "Co-creation Opportunity Formation Support Program (COI-NEXT)
Not applicable
Zebra Holdings Corporation
Not applicable
Yokohama City University Ethics Committee
3-9 Fukuura, Kanazawa-ku, Yokohama City, Kanagawa , Kanagawa

+81-453707627

rinri@yokohama-cu.ac.jp
Approval

Sept. 28, 2023

none

History of Changes

No Publication date
5 Oct. 28, 2024 (this page) Changes
4 June. 03, 2024 Detail Changes
3 May. 28, 2024 Detail Changes
2 Dec. 22, 2023 Detail Changes
1 Oct. 31, 2023 Detail