Pregnancy Pregnant women
Conditions
Interventions
Participants will use a smartphone application developed for perinatal women to receive psychoeducation (PE) and CBT programs. The application includes educational videos that explain pregnancy-relate
Cognitive Behavioral Therapy
Sponsors
Toyomoto Rie
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pregnant women between 10 and 20 weeks of gestation. 2)Aged 18 years or older at the time of obtaining consent for study participation. 3)Ownership of a personal smartphone. 4)Initiation of lessons within one week after providing written informed consent.
Exclusion criteria
Exclusion criteria: 1)Inability to read or write in Japanese. 2)Presence of severe physical illnesses that preclude the use of the app. 3)Receiving treatment for mental health issues at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Point prevalence of depression at one month postpartum, defined as a total score of 9 or higher on the Edinburgh Postnatal Depression Scale (EPDS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of a major depressive episode by six months postpartum by Composite International Diagnostic Interview (CIDI). 2.Change in EPDS from baseline to week 6 and week 20 and 1, 3 and 6 months postpartum. 3.Changes in the Insomnia Severity Index (ISI) from baseline to week 6 and at 1, 3 and 6 months postpartum. 4.Changes in the CBT Skills Scale from baseline to week 6 and at 1 month postpartum. 5.The Japanese version of Mother-to- Infant Bonding Scale Japanese version (MIBS-J) at 1, 3 and 6 months postpartum. 6.Client Satisfaction Questionnaire-3 (CSQ-3), adherence to smartphone CBT, co-interventions, safety information at week 6 and 6 months postpartum. | — |
Contacts
Public ContactRie Toyomoto
Kyoto University, Graduate School of Medicine/School of Public Health
Outcome results
None listed