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

JRCT ID: jRCT1030240315

Registered date:02/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prevention of depression
• Date of first enrollment: 27/07/2023
• Target sample size: 175
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

Psychological distress (K6)
Perceived stress (PSS)
Fitbit

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

(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

Exclude criteria

(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.

Related Information

• Primary Sponsor: Takizawa Ryu
• Source(s) of Monetary Support: Japan Society for the Promotion of Science (JSPS)