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Assessing the Effectiveness of Digital CBT-I in Enhancing Sleep for Pregnant Women

Assessing the Effectiveness of Digital CBT-I in Enhancing Sleep for Pregnant Women - dCBT-I for Pregnant Women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058183
Enrollment
60
Registered
2025-06-23
Start date
2025-06-16
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Healthy pregnant women and infants

Interventions

Implementing dCBT-I using a smartphone app.

Sponsors

Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women currently receiving outpatient treatment at the Department of Obstetrics and Gynecology at Kyushu University Hospital 2. Patients who fully understand the research plan and are able to give their own informed consent

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with insomnia, restless legs syndrome, or sleep apnea syndrome 2. Patients taking sleeping pills 3. Patients with psychiatric disorders (depression, panic disorder, etc.) 4. Patients with high-risk pregnancies (pregnancy-induced hypertension, heart disease, epilepsy, etc.) 5. Multiple pregnancies 6. Patients who are deemed inappropriate for clinical practice by researchers or physicians

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disorders during late pregnancy

Secondary

MeasureTime frame
Incidence of sleep disorders at 1 month and 6 months postpartum, the 3D sleep scale, sleep duration and nighttime awakenings, the Edinburgh Postnatal Depression Scale, and pregnancy and delivery complications.

Countries

Japan

Contacts

Public ContactSeiichi Morokuma

Kyushu University Department of Health Sciences, Graduate School of Medical Sciences

morokuma.seiichi.845@m.kyushu-u.ac.jp+81-92-642-6708

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026