Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063318) titled 'A Study of the Effects of Mindfulness for Life in Japanese Adults' on Oct. 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Nagoya University of Economics
Condition:
Condition - Adults aged 18 years or older residing in Japan
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 60
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072462
Disclaimer: Curated by HT Syndication.