The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster Randomized controlled trial

The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster Randomized controlled trial - The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055316

Enrollment

120

Registered

2024-08-23

Start date

2024-03-04

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

Maternal and Postpartum Sleep Disorder/Insomnia

Interventions

The intervention group in this study will use the NEC Personal Sleep Coach, which is a sleep improvement program as a digital brief behavioural therapy for insomnia (dBBT-I). In the intervention grou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Singleton, low risk primiparas and their partners, and can understand Japanese.

Exclusion criteria

Exclusion criteria: Pregnancies with serious complications (cardiac, hematological, autoimmune, etc.) Pregnancies with serious fetal complications (fetal malformations, chromosomal abnormalities, etc.) Persons with any kind of sleep or wakefulness disorder, Persons undergoing treatment for mental illness. Multipara

Design outcomes

Primary

Measure	Time frame
Comparison of the Athens Insomnia Scale (AIS) scores before intervention (the 2nd trimester of pregnancy) and the 3rd trimester.	—

Secondary

Measure	Time frame
The following scales for women and partners at baseline (2nd trimester), immediately after intervention, 1 month after intervention, 3rd trimester, 1 month postpartum, and 4 months postpartum; 1 Athens Insomnia Scale 2 Edinburgh Postnatal Depression Scale (EPDS) 3 The Circadian Energy Scale (CIRENS) 4 Restorative Sleep Questionnaire (RSQ) 5 Sleep Debt Index (SDI) 6 Ford Insomnia Response to Stress Test (FIRST) 7 Cambridge-Hopkins RLS Short Form questionnaire 13 (CH-RLSq13) version 2.16 8 Three-Item Loneliness Scale 9 Generalized Anxiety Disorder-7 (GAD-7)	—

Measure

Time frame

The following scales for women and partners at baseline (2nd trimester), immediately after intervention, 1 month after intervention, 3rd trimester, 1 month postpartum, and 4 months postpartum; 1 Athens Insomnia Scale 2 Edinburgh Postnatal Depression Scale (EPDS) 3 The Circadian Energy Scale (CIRENS) 4 Restorative Sleep Questionnaire (RSQ) 5 Sleep Debt Index (SDI) 6 Ford Insomnia Response to Stress Test (FIRST) 7 Cambridge-Hopkins RLS Short Form questionnaire 13 (CH-RLSq13) version 2.16 8 Three-Item Loneliness Scale 9 Generalized Anxiety Disorder-7 (GAD-7)

—

Countries

Japan

Contacts

Public ContactYoriko Kotoku

Nagasaki University Institute of Biomedical Sciences

y-kotoku@nagasaki-u.ac.jp095-819-7952

Outcome results

None listed

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