UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063318 |
|---|---|
| Receipt number | R000072462 |
| Scientific Title | Effects and Mechanisms of Mindfulness for Life in Japanese Adults: A Proof-of-Concept Randomized Controlled Trial Using Mixed Methods |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 17:30:47 |
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Basic information
Public title
A Study of the Effects of Mindfulness for Life in Japanese Adults
Acronym
Mindfulness for Life Study
Scientific Title
Effects and Mechanisms of Mindfulness for Life in Japanese Adults: A Proof-of-Concept Randomized Controlled Trial Using Mixed Methods
Scientific Title:Acronym
MFL-J Study
Region
| Japan |
Condition
Condition
Adults aged 18 years or older residing in Japan
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are as follows:
1)To explore the potential of Mindfulness for Life (MFL) to enhance ikigai among Japanese adults.
2)To compare changes in ikigai and well-being and examine whether ikigai may serve as an outcome that is more sensitive to changes associated with MFL.
3)To explore the psychological mechanisms underlying changes associated with MFL using both quantitative and qualitative data, and to refine an integrative theoretical model incorporating ikigai.
4)To explore the acceptability and feasibility of MFL within the Japanese cultural context.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary assessment time point will be post-intervention (after completion of the eighth session; T3), and the between-group difference in Ikigai-9 scores between the MFL group and the wait-list control group will be examined.
Key secondary outcomes
Mental wellbeing will be assessed using the 7item Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS). The primary assessment time point for this secondary outcome will be post intervention (after completion of the eighth session T3), and the between group difference in SWEMWBS scores between the MFL group and the waitlist control group will be examined.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness for Life (MFL) is an online group-based program consisting of eight weekly sessions of approximately two hours each, including a one-day retreat during the program. Each session consists of mindfulness practices, cognitive exercises, psychoeducation, and group reflection. Participants are encouraged to engage in home practice between sessions and to integrate mindfulness practices into their daily lives.
Interventions/Control_2
Wait-list control group: Participants will not receive MFL during the primary assessment period and will receive MFL after completion of the primary assessment period.
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)Adults aged 18 years or older.
2) Willing and expected to attend at least six of the eight sessions during the assigned intervention period and to engage in home practice, regardless of the group or intervention period to which they are randomly allocated.
3)Have access to a stable internet connection and an appropriate device and are able to participate in online sessions with their camera turned on.
Key exclusion criteria
1)Currently receiving treatment for a mental disorder at the time of screening.
2)Current suicidal ideation.
3)A history of traumatic experience that continues to have a significant psychological impact and for which participation in the study may pose a risk of worsening the participant's condition.
4)Current problems with alcohol or drug dependence.
5)Continuing significant impact of a major life event that occurred within the past six months.
6)Previous or current participation in a structured mindfulness-based intervention lasting eight weeks or longer.
7)Previous or current experience of teaching structured mindfulness-based interventions, such as MBCT or MBSR.
8)Considered unsuitable for participation for other reasons related to safety or study procedures.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuji |
| Middle name | |
| Last name | Ietsugu |
Organization
Nagoya University of Economics
Division name
Faculty of Human Life Sciences
Zip code
484-8504
Address
61-1 Uchikubo, Inuyama, Aichi 484-8504, Japan
TEL
0568-67-0511
iezgu@nagoya-ku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuji |
| Middle name | |
| Last name | Ietsugu |
Organization
Nagoya University of Economics
Division name
Faculty of Human Life Sciences
Zip code
484-8504
Address
61-1 Uchikubo, Inuyama, Aichi 484-8504, Japan
TEL
0568-67-0511
Homepage URL
https://research-mindfulness-for-life-rct.netlify.app/
iezgu@nagoya-ku.ac.jp
Sponsor or person
Institute
Nagoya University of Economics
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University of Economics
Address
61-1 Uchikubo, Inuyama, Aichi 484-8504, Japan
Tel
0568-67-0511
tomijin@nue.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 | 10 | Month | 16 | 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 | 09 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 10 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072462
