UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053617 |
|---|---|
| Receipt number | R000061190 |
| Scientific Title | Exploring the effects of Relationship Building Support by Another Me |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/08/20 16:39:19 |
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Basic information
Public title
Exploring the effects of Relationship Building Support by Another Me
Acronym
Exploring the effects of Relationship Building Support by Another Me
Scientific Title
Exploring the effects of Relationship Building Support by Another Me
Scientific Title:Acronym
Exploring the effects of Relationship Building Support by Another Me
Region
| Japan |
Condition
Condition
Male/Female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on the hypothesis that the use of dialogue reproduction can reduce interpersonal anxiety, this study aims to investigate the possibility that viewing communication between one's own Another Me (an autonomously moving avatar character that mimics oneself) and others can reduce tension and anxiety during online dialogue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate
Key secondary outcomes
Liebowitz Social Anxiety Scale
Social Reticence Scale
Mood Inventory
Implementation Outcome Scales for Digital Mental Health
Questionnaire on anxiety and nervousness
Blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The research subjects will watch their own Another Me dialogue videos at their homes, followed by an online dialogue.
Interventions/Control_2
The video of another person's Another Me dialogue is viewed in the home of the research subject, followed by an online dialogue.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who are aware that they get nervous when talking to new people (stage fright)
2) Adults 18 years of age or older
3) Those who are able to visit the Minatomirai office
4) Those who can give written consent to participate in this study.
Key exclusion criteria
1) Patients who have difficulty in speaking Japanese
2) Patients with a history of atrial fibrillation or arrhythmia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Miyazaki |
Organization
Yokohama City University
Division name
Research and Industry-Academia Collaboration Division
Zip code
220-0012
Address
3-7-1 Minatomiari, Nishi-ku, Yokohama-shi, Kanagawa
TEL
05035757535
johney@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Yamasato |
Organization
Yokohama City University
Division name
Research and Industry-Academia Collaboration Division
Zip code
220-0012
Address
3-7-1 Minatomiari, Nishi-ku, Yokohama-shi, Kanagawa
TEL
05035757535
Homepage URL
takeda.ami.nm@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
NTT Human Informatics Laboratories
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
Tel
045-370-7627
rinri@yokohama-cu.ac.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
| 2024 | Year | 02 | Month | 15 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061190
