UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048436 |
|---|---|
| Receipt number | R000055107 |
| Scientific Title | Analysis of the effective therapist's communication patterns towards the development of counseling AI |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/01/22 09:28:06 |
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Basic information
Public title
Analysis of the effective therapist's communication patterns towards the development of counseling AI
Acronym
Development of counseling AI
Scientific Title
Analysis of the effective therapist's communication patterns towards the development of counseling AI
Scientific Title:Acronym
Development of counseling AI
Region
| Japan |
Condition
Condition
Adults with depressive symptoms
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The final goal of this study is to develop of counseling with AI. In order to achieve the goal, the aim of this study is to identify the effective therapist's communication patterns.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Correlation between scores of PGI(Patient Global Impression-Improvement)or counseling session evaluation and number of occurrences of utterance code of counselor or client
2) Correlation between mean difference in CES-D(Center for epidemiologic studies depression Scale) scores between baseline and postintervention and number of occurrences of utterance code of client
Key secondary outcomes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with depressive symptoms
2) Patients who are decided to be able to perform counseling continuously by counselor
3) Patients who received sufficient explanation about this study, and fully understand it and consent to participate.
4) Patients who are between 20 and 65 years at the time of obtaining consent.
5) Patients who have an internet environment which is able to perform online counseling and have smartphone.
Key exclusion criteria
1) Patients with intellectual disability, major neurocognitive disorder, and speech disorder which are not able to communicate in counseling.
2) Patients who are judged by the counselor or researcher to be inappropriate for participating this study
3) Patient's native language is not Japanese.
4) Patients who receive other counseling.
5) Patients who are judged by the doctor to be inappropriate for participating this study if they receive any treatment such as psychiatry.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kim |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira city, Tokyo
TEL
042-341-2711
kim@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yuuki |
| Middle name | |
| Last name | Yokota |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogawahigashi, Kodaira city, Tokyo
TEL
042-341-2711
Homepage URL
y.yokota@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
FrontierLink Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1, Ogawahigashi, Kodaira city, Tokyo
Tel
042-341-2711
rinri-jimu@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The recorded data of counseling will be collected. Statistical analysis will be performed on the results of web forms (including face sheet, CES-D, STAI, evaluation of counseling, CGI, and PGI).
Management information
Registered date
| 2022 | Year | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055107
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
