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Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial

Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial - Effect of Digital Device Interventions on Insomnia Symptoms among Working Women during Menopause: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060496
Enrollment
900
Registered
2026-01-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Symptoms

Interventions

Intervention using a Sleep diary integrated CBTI based application. The sleep coaching program consists of a total of 26 tasks, including cognitive behavioral therapy components such as stimulus con

Sponsors

Akita University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Presence of at least mild menopausal symptoms: total MRS score >= 5 2. Presence of at least mild insomnia symptoms: ISI score >= 8 3. Not taking prescription hypnotics from medical institutions 4. Not taking over-the-counter sleep aids

Exclusion criteria

Exclusion criteria: 1. History of post-traumatic stress disorder (PTSD) or depressive disorders (including suicidal ideation) 2. Sleep disorders other than insomnia (e.g., restless legs syndrome, sleep apnea syndrome) 3. Currently receiving pharmacotherapy with hypnotics or psychotherapy for sleep problems 4. Shift work employment 5. High risk of serious consequences due to sleep deprivation (e.g., truck drivers) 6. Major life events within the past month (e.g., hospitalization, bereavement) 7. Presence of systemic underlying diseases such as cancer or intractable disorders 8. History of surgical menopause or premature menopause

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index: ISI

Secondary

MeasureTime frame
1. Pittsburgh Sleep Quality Index: PSQI 2. Menopause Rating Scale: MRS 3. Work Functioning Impairment scale: WFun 4. Generalized Anxiety Disorder-7: GAD-7 5. Patient Health Questionnaire-9: PHQ-9 6. Five Facet Mindfulness Questionnaire: FFMQ 7. Cognitive Fusion Questionnaire: CFQ-7

Countries

Japan

Contacts

Public ContactSongee Jung

Akita University Department of Environmental Health Science and Public Health, Graduate School of Medicine

jonsoni@med.akita-u.ac.jp018-884-6087

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026