Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059398) titled 'Effects of a Mindfulness Practice Program Supported by SNS (LINE) on Health Outcomes among Community-Dwelling Older Adults' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Kyushu University
Condition:
Condition - Psychological stress, anxiety/depressive tendency, sleep disturbance, and chronic pain in community-dwelling older adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 95
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067377
Disclaimer: Curated by HT Syndication.