Healthy pregnant women and their husbands or partners
Conditions
Interventions
At 8 months of pregnancy (first intervention), participants will be asked to watch a video-based brief CBT-I program consisting of sleep hygiene education, sleep restriction therapy, stimulus control
Sponsors
Nippon Medical School
Kitasato University, Tokai University, Tokyo Women'
s Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Couples who participate in municipal maternal-child health services or visit a hospital/clinic between October 1, 2025, and June 30, 2026. 2. Couples in which both partners are 18 years or older. 3. Couples in which the pregnant partner is between 4 and 8 months of gestation. 4. Couples with an expected delivery date between April 2, 2026, and August 5, 2026. 5. Couples who have concerns or interests regarding sleep. 6. Couples who receive an explanation of the study and provide informed consent to participate. Note: Couples are defined as a man and a woman who will share childbirth and child-rearing, regardless of legal marital status.
Exclusion criteria
Exclusion criteria: 1. Couples in which either partner is currently receiving psychiatric or psychosomatic medical care. 2. Couples with a multiple pregnancy. 3. Couples in which only one partner can participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postpartum depression among couples at 3 months postpartum (Assessed by EPDS and PHQ-9) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Postpartum depression among couples at 9 months pregnant (Assessed by EPDS and PHQ-9) 2.Insomunia among couples at 9 months pregnant and 3 months postpartum (Assessed by ISI) 3.Anxiety among couples at 9 months pregnant and 3 months postpartum (Assessed by GAD-7) 4.Marital satisfaction among couples at 9 months pregnant and 3 months postpartum (Assessed by QMI) 5.Bonding to infant among couples at months postpartum (Assessed by MIBS) | — |
Countries
Japan
Contacts
Public ContactShota Matsunaga
Tokyo Women's Medical University School of Medicine
Outcome results
None listed