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Sept. 02, 2024

Sept. 02, 2024

jRCT1030240315

A study of mindfulness-based intervention using a smartphone app among employed women and their adolescent children

A study of mindfulness-based intervention using a smartphone app among employed women and their adolescent children

Takizawa Ryu

The University of Tokyo

7-3-1, Hongo, Bunkyo-ku, Tokyo

+81-3-5841-1397

takizawar-tky@umin.ac.jp

Adachi Koichiro

The University of Tokyo

7-3-1, Hongo, Bunkyo-ku, Tokyo

+81-3-5841-1397

adachi-koichiro342@g.ecc.u-tokyo.ac.jp

Recruiting

July. 27, 2023

July. 27, 2023
175

Interventional

randomized controlled trial

double blind

no treatment control/standard of care control

crossover assignment

health services research

(1) Able to communicate in Japanese
(2) Subjects who give full consent in the participation of the study
(3) Able to participate in face-to-face measurements at the laboratory

Working women
(1) Between the ages of 18 and 64 years
(2) Working more than 20 hours per week
(3) Biologically female

Children
(1) Between the ages of 12 and 17 years
(2) Enrolled in junior or senior high school
(3) Subjects whose parents are participating in this study
(4) Living with parents

(1) Receiving treatment for mental health disorders
(2) Women who are currently pregnant or may become pregnant within 6 months
(3) Subjects with K6 score >=13 at screening (equivalent to a severe mental disorder)

Working women
(1) On a leave of absence

Children
(1) Not attending school regularly due to illness.

12age old over
64age old under

Both

Prevention of depression

Intervention group:
Participants perform 8-weeks of mindfulness-based meditation with guided audio for about 10 minutes on an app. The guided meditations in each two-week module are as follows: weeks 1-2: a breathing meditation; weeks 3-4: a body scan meditation; weeks 5-6: a breath-sound-body meditation; and weeks 7-8: a loving-kindness meditation.

Wait-list control group:
Participants are asked to spend the 8-week control period as usual. After the control period, participants perform the mindfulness-based meditation for 8 weeks.

Depressin

mindfulness

D003863

D064866

Psychological distress (K6)
Perceived stress (PSS)
Fitbit

Well-being (SWLS)
Quality of Life (EQ-5D-5L)
Trait anger (STAXI-2)
Affect (PANAS, Affect Grid)

Mindfulness (MAAS, CAMM)
Self-compassion (SCS-SF)
Cognitive flexibility (CFS)
Emotion regulation (CERQ)
Self-esteem (RSES)
Environmental reward observation (EROS)
Resilience (BRS)
Interpersonal Reactivity (IRI)

Job Stress (Brief Job Stress Questionnaire)
Presenteeism (WHO-HPQ)
Work-life balance (SWING)
Psychological Safety (PSS)
Creativity (self-perceived creativity)
Help-seeking (ATSPPH-SF)

Somatic symptom (SSS-8)
Symptoms of premenstrual syndrome (DRSP)
Insomnia severity (ISI)
Menopausal symptoms (MRS)

Marital relationship satisfaction
Mindful parenting (IM-P)
Pediatric symptom (PSC)
Parent-adolescent communication (PACS)

Heart rate, Heart rate variability
Near-Infrared Spectroscopy (NIRS)
Pupillary response

The University of Tokyo
Japan Society for the Promotion of Science (JSPS)
Not applicable
Research Ethics Committee of the University of Tokyo
7-3-1, Hongo, Bunkyo-ku, Tokyo, Tokyo

+81-3-3812-2111

lifescience.adm@gs.mail.u-tokyo.ac.jp
Approval

Aug. 09, 2024

No

None