UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063055 |
|---|---|
| Receipt number | R000071788 |
| Scientific Title | Human-Supported Digital Acceptance and Commitment Therapy (dACT-G) Program for Japanese Workers at Risk of Burnout: A Two-Arm Parallel-Group Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/26 |
| Last modified on | 2026/09/25 18:33:54 |
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Basic information
Public title
Hybrid Digital Intervention Facilitating Valued Action for Workplace Mental Health
Acronym
WAVE Study
Scientific Title
Human-Supported Digital Acceptance and Commitment Therapy (dACT-G) Program for Japanese Workers at Risk of Burnout: A Two-Arm Parallel-Group Randomized Controlled Trial
Scientific Title:Acronym
WAVE Study
Region
| Japan |
Condition
Condition
Workers from the general working population at risk of burnout
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether a human-supported hybrid digital intervention based on acceptance and commitment therapy (dACT-G), a cognitive-behavioral approach, reduces burnout compared with a waitlist control among workers from the general working population at risk of burnout, using a two-arm parallel-group randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the level of burnout measured with the Japanese version of the Burnout Assessment Tool (BAT-J). It is assessed at two time points: before the intervention (Time 1) and at the end of the intervention, 5 weeks after the start of the program (Time 2).
Key secondary outcomes
Unless otherwise specified, outcomes are assessed before the intervention (Time 1) and at the end of the intervention (Time 2).
[Self-report questionnaires]
- Depressive symptoms: Japanese version of the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-J)
- Health-related quality of life: Japanese version of the EuroQol 5 Dimensions 3-Level (EQ-5D-3L)
- Perceived stress: Japanese version of the Perceived Stress Scale (PSS)
- Valued living: Japanese version of the Valuing Questionnaire (VQ)
- Work-related psychological flexibility: Japanese version of the Work-related Acceptance and Action Questionnaire (WAAQ)
- Work engagement: Japanese version of the 9-item Utrecht Work Engagement Scale (UWES-9)
- Program satisfaction (intervention group, Time 2 only)
- Program feedback (intervention group, Time 2 only)
[Log data (intervention group only)]
- Viewing rate of the videos, and frequency of use and continuation rate of the videos and the web tool
- Program participation rate and continuation rate
[Qualitative evaluation]
- After the intervention (Time 2), a subsample of intervention group participants take part in a semi-structured interview of approximately 30 minutes based on an interview guide, covering their experience of using the program, feedback on its content, and their expectations for the program.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: dACT-G
dACT-G is a program based on acceptance and commitment therapy (ACT), a cognitive-behavioral approach, that combines a digital tool with human support.
The intervention lasts 5 weeks, starting on the day of the initial one-to-one session. Participants complete the following components online.
(1) At the start of the program, a one-to-one session (approximately 30 minutes, via a web conferencing system) with a staff member to clarify goals and schedule the weekly sessions.
(2) Five weekly pre-recorded video sessions (approximately 30 minutes each) with exercises, delivered through a web- and mobile-based digital tool.
(3) A weekly online Q&A webinar during the intervention period. Participants may attend live or watch the recording.
(4) At the end of the program, a one-to-one session (approximately 15 minutes, via a web conferencing system) with a staff member to review the program as a whole.
Interventions/Control_2
Waitlist control group
Participants receive no study intervention during the 5-week intervention period. After all participants in the intervention group have completed the intervention, they are offered the program without the one-to-one sessions (the video sessions and the Q&A webinars).
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
- 18 years of age or older
- Able to answer the questionnaires and participate in the program in Japanese
- Employed
- Mean score of 2.59 or higher on the BAT-J (at risk of burnout)
Key exclusion criteria
- Individuals who do not meet one or more of the inclusion criteria
- Currently on leave of absence or planning to take leave of absence
- QIDS-J total score of 21 or higher (very severe), or high suicide risk (score of 2 or higher on QIDS-J item 12, thoughts of death or suicide)
- BAT-J score of less than 2.59
- Prior exposure to the intervention program used in this study
- Individuals receiving outpatient treatment for a mental disorder who have not obtained permission to participate from their attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Eguchi |
Organization
University of Occupational and Environmental Health, Japan
Division name
Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka
TEL
093-603-1611
j-seihkn@mbox.med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikari |
| Middle name | N. |
| Last name | Takashina |
Organization
Awarefy Inc.
Division name
Awarefy Mental Research Institute
Zip code
163-0224
Address
GROWTH Shinjuku ROOM4, Shinjuku Sumitomo Building 24F, 2-6-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
050-5476-1822
Homepage URL
hikari.takashina@awarefy.com
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Awarefy Mental Research Institute, Awarefy Inc.
Name of secondary funder(s)
Awarefy Inc. (joint research funds); University of Occupational and Environmental Health, Japan (departmental research funds)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research, University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka
Tel
093-691-7205
daigakurinri@mbox.pub.uoeh-u.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
| 2026 | Year | 09 | Month | 26 | 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
Individual participant data will not be shared.
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 07 | 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
| 2026 | Year | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071788
