UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062445 |
|---|---|
| Receipt number | R000071459 |
| Scientific Title | A micro-randomization trial of personalized skill training for stress management |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/03 12:02:23 |
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Basic information
Public title
Evaluation of a personalized skill training program for stress management
Acronym
PerSkiT
Scientific Title
A micro-randomization trial of personalized skill training for stress management
Scientific Title:Acronym
PerSkiT
Region
| Japan |
Condition
Condition
Occupational stress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to evaluate the efficacy of personalized messaging within a skill-training program for stress management among employees in Japan, using a micro-randomized design. After each training module, participants will be randomly assigned to receive a personalized message, a standard message, or no message. The effects of these conditions will be evaluated on stress levels, motivation, engagement with the training program, and other psychological/behavioral aspects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Brief stress checklist scores assessed after completion of each training module during the intervention period (up to 40 assessments).
Key secondary outcomes
- Motivation, intention, and/or (continuous) engagement with the training program
- Completion rate of training modules
- Time to program completion
- Follow-up stress checklist scores
- Associations with psychological characteristics and lifestyle-related variables
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study is a micro-randomized trial using an online stress-management and mental health training program.
Participants complete approximately 40 learning modules over one month. After each completed module, participants are randomly assigned in a 1:1:1 ratio to one of the following conditions:
(1) Personalized message
(2) Standard message
(3) No message
Each participant experiences multiple conditions during the study period. Brief stress measures and motivational assessments are collected after each session.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Able to provide informed consent voluntarily
2. Aged 18 years or older at the time of consent
3. Resident in Japan
4. Able to participate in online surveys and online learning programs
5. Currently employed (full-time or part-time)
Individuals who do not meet the inclusion criteria
Key exclusion criteria
NA
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Katahira |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, Japan
TEL
050-3522-4472
k.katahira@aist.go.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Katahira |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, Japan
TEL
050-3522-4472
Homepage URL
k.katahira@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Kentaro Katahira
Funding Source
Organization
Advantage Risk Management 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
Toranomon Hospital institutional review board
Address
Toranomon 2-2-2, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2026 | Year | 08 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071459
