UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058713 |
|---|---|
| Receipt number | R000067131 |
| Scientific Title | Efficacy of transactional analysis self-work program using smartphone app and video streaming |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/11 07:49:08 |
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Basic information
Public title
Efficacy of transactional analysis self-work program using smartphone app and video streaming
Acronym
Efficacy of transactional analysis self-work program using smartphone app and video streaming
Scientific Title
Efficacy of transactional analysis self-work program using smartphone app and video streaming
Scientific Title:Acronym
Efficacy of transactional analysis self-work program using smartphone app and video streaming
Region
| Japan |
Condition
Condition
depressive state (QIDS-J>5)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of transactional analysis self-work program using smartphone app and video streaming on schoolteachers' mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
depressive state score (QIDS-J)
Key secondary outcomes
Perceived stress scale, Rosenberg's Self Esteem Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
8-week transactional analysis self-work program
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
public school teachers, QIDS-J>5
Key exclusion criteria
severe psychiatric diseases (schizophrenia, dissociative disorder, suicidal attempt etc)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kenjiro |
| Middle name | |
| Last name | Tsubono |
Organization
Tokai Central Hospital
Division name
psychosomatic medicine
Zip code
5068601
Address
4-6-2, Sohara-Higashijima-cho, Kakamigahara, Gifu
TEL
0583823101
tubonok@tokaihp.jp
Public contact
Name of contact person
| 1st name | Kenjiro |
| Middle name | |
| Last name | Tsubono |
Organization
Tokai Central Hospital
Division name
psychosomatic medicine
Zip code
5068601
Address
4-6-2, Sohara-Higashijima-cho, Kakamigahara, Gifu
TEL
0583823101
Homepage URL
tubonok@tokaihp.jp
Sponsor or person
Institute
Tokai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Mutual Aid Association of Public School Teachers
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai Central Hospital
Address
Sohara-Higashijima-cho 4-6-2, Kakamigahara, Gifu
Tel
0583823101
ikechika@tokaihp.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
| 2025 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067131
