UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059398 |
|---|---|
| Receipt number | R000067377 |
| Scientific Title | A Mixed-Methods Study on Adherence, Psychological, Social, and Physiological Effects of an SNS-Based Mindfulness Practice Program and the Impact of Notification Frequency among Community-Dwelling Middle-Aged and Older Adults |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/14 17:19:00 |
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Basic information
Public title
Effects of a Mindfulness Practice Program Supported by SNS (LINE) on Health Outcomes among Community-Dwelling Older Adults
Acronym
Mindfulness-Health with LINE
Scientific Title
A Mixed-Methods Study on Adherence, Psychological, Social, and Physiological Effects of an SNS-Based Mindfulness Practice Program and the Impact of Notification Frequency among Community-Dwelling Middle-Aged and Older Adults
Scientific Title:Acronym
MIND-LINE Study
Region
| Japan |
Condition
Condition
Psychological stress, anxiety/depressive tendency, sleep disturbance, and chronic pain in community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the feasibility of lifestyle-integrated mindfulness practice supported by SNS (LINE) among community-dwelling middle-aged and older adults, (1) to clarify adherence and its psychological, social, and physiological correlates, as well as longitudinal changes in health indicators, and (2) to compare the causal effects of notification frequency on adherence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence to daily-life integrated mindfulness practices (8-week average) among community-dwelling middle-aged and older adults, and between-group differences in adherence by push notification frequency.
Key secondary outcomes
1.Changes in psychological indicators (Perceived Stress Scale [PSS], Five Facet Mindfulness Questionnaire [FFMQ], Pittsburgh Sleep Quality Index [PSQI], etc.)
2.Changes in physiological indicators (blood pressure)
3.Changes in social factors and self-rated health
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Community-dwelling adults aged >= 60 years will participate in an 8-week lifestyle-integrated mindfulness program.
- Face-to-face sessions: once weekly, 60 minutes x 8 sessions. Guided practices include breathing meditation, walking meditation, mindful eating, body scan, daily-life applications, and self-compassion. Each session includes goal setting for home practice.
- Home practice support (ICT): 8 daily notifications (07:30, 09:30, 11:30, 13:30, 15:30, 17:30, 19:30, 21:30) with 5-10 min guided videos via LINE. A daily 20:00 questionnaire collects practice status, content, and concentration (1-5). URL clicks are recorded as an auxiliary adherence indicator.
Interventions/Control_2
Same content as Intervention 1, except that home practice support (ICT) consists of a single daily notification at 07:30. All other components are identical.
Interventions/Control_3
Same content as Intervention 1, except that home practice support (ICT) consists of a single notification only on day 1 at 07:30. No further notifications are sent. All other components are identical.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Community-dwelling older adults aged 60 years and over
- Independent in activities of daily living (ADL)
- Able to understand the purpose of the study and provide written informed consent
- Regular users of smartphones or tablets and able to participate in SNS-based communication and intervention
Key exclusion criteria
- Individuals with severe dementia or psychiatric disorders that interfere with participation
- Individuals with severe physical conditions judged by a physician to be inappropriate for meditation practice
- Individuals expected to have difficulty continuing participation due to relocation or long-term hospitalization during the study period
- Any other cases deemed inappropriate by the principal investigator
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Faculty of Arts and Science
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka 819-0395, Japan
TEL
092-802-6071
kishimoto@artsci.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Faculty of Art and Science
Zip code
819-0395
Address
No.744, Motooka, Nishi-ku, Fukuoka, Japan
TEL
092-802-6071
Homepage URL
kishimoto@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Hiro Kishimoto
Funding Source
Organization
Itoshima City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Health Sciences and Counseling Center Joint Ethics Committee
Address
No.744, Motooka, Nishi-ku, Fukuoka, Japan
Tel
092-802-5881
kishimoto@artsci.kyushu-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
九州大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 14 | 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
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067377
