Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059203) titled 'Verification of retention rates in mindfulness seminars' on Feb. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - No treatment
Primary Sponsor:
Institute - NTT health insurance union
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the retention rate of a newly developed mindfulness seminars
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - 6-week Mindfulness Program (including online seminars, audio guides, and Fitbit integration)
Interventions/Control_2 - Waitlist control group (receives the same recorded seminar after the intervention group, with Fitbit integration)
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Healthy men and women aged 20 years or older at the time of obtaining informed consent
2.Individuals enrolled in the NTT Health Insurance Association
3.Individuals with a properly functioning connection to the Fitbit app
4.Individuals who can consent to data acquisition through the use of Fitbit API integration
5.Individuals who can participate in seminars and questionnaires conducted during the research period
Key exclusion criteria - 1. Individuals who are not currently using Fitbit and are not expected to use it in the future
2. Individuals who have experienced discomfort during previous meditation sessions or similar activities
3. Individuals who have experienced skin diseases due to wearing Fitbit
4. Individuals who received treatment for mental or sleep disorders at a psychosomatic medicine department in the past two years
Target Size - 200
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 07 Day
Date of IRB - 2025 Year 07 Month 16 Day
Anticipated trial start date - 2025 Year 10 Month 02 Day
Last follow-up date - 2026 Year 01 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067709
Disclaimer: Curated by HT Syndication.