UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057430 |
|---|---|
| Receipt number | R000065622 |
| Scientific Title | A randomized controlled trial evaluating the effectiveness of .b, a mindfulness program for adolescents, among parents and teachers. |
| Date of disclosure of the study information | 2025/03/28 |
| Last modified on | 2026/03/09 11:50:50 |
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Basic information
Public title
A randomized controlled trial evaluating the effectiveness of .b (Dot Be), a mindfulness program for adolescents, among parents and teachers.
Acronym
Evaluating the effectiveness of .b among parents and teachers.
Scientific Title
A randomized controlled trial evaluating the effectiveness of .b, a mindfulness program for adolescents, among parents and teachers.
Scientific Title:Acronym
A randomized controlled trial evaluating the effectiveness of .b among parents and teachers.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Parents and teachers who wish to participate in .b, a 9-week (10-session) mindfulness program for adolescents developed in the UK, will be randomly assigned to either an early intervention group or a waitlist control group. The effects will be exploratorily examined and compared using self-report questionnaires.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Mindfulness (Five Facet Mindfulness Questionnaire: 24-item version)
2. Self-compassion (Self-Compassion Scale: Japanese version)
3. Mood profile (Profile of Mood States 2: Japanese short form for adults)
4. Health-related quality of life (SF-12: Japanese version)
5. Perceived stress scale (Japanese 14-item version of the Perceived Stress Scale)
6. Parent-child relationship scale (TBD)
Key secondary outcomes
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
.b program
Interventions/Control_2
Waitlist control group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals who wish to participate after attending the introduction session
2. Individuals who can attend at least 7 out of the 9 weekly one-hour sessions following the introduction
3. Individuals willing to engage in approximately 10 minutes of home practice on at least 6 out of 7 days each week
4. Individuals who consent to completing questionnaires before and after the program, and agree to the possibility of their anonymized data being published under data protection regulations
Key exclusion criteria
1. Individuals who have previously participated in an 8-week mindfulness program
2. Individuals with conditions such as social anxiety that may interfere with participation
3. Individuals deemed unsuitable as research participants by the principal investigator for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ito |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
Kansai Medical University, 2-5-1 Shinmachi, Hirakata City.
TEL
072-804-0101
edu@mbsrjapan.com
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Ito |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
Kansai Medical University, 2-5-1 Shinmachi, Hirakata City.
TEL
072-804-0101
Homepage URL
edu@mbsrjapan.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga University, Osaka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata City.
Tel
072-804-2440
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024312
Org. issuing International ID_1
Kansai Medical University
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 | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
Results
89 participants were included in the analysis. In the .b group, significant improvements were observed in all measures except PS Laxness (paired t-tests), with effect sizes ranging from small to large (Hedges'g = .35 to .79). No significant changes were observed in the waitlist group. Post-intervention ANCOVA revealed that the .b group showed significantly greater improvements than the waitlist group on all measures except mental health-related QOL and PS, with small-to-large effect sizes.
Results date posted
| 2026 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 03 | Month | 07 | Day |
Baseline Characteristics
Parents and teachers without significant physical or psychiatric disorders were recruited via the internet. After providing informed consent, participants were randomly assigned to either the .b group (n = 48; 7 teachers) or a waitlist control group (n = 48; 6 teachers).The mean age was 46.4 years (SD = 6.0); 94.4% were female, and 85.4% participated as parents. No significant between-group differences were found in demographic or baseline variables.
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 | 03 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 01 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065622
