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Research to develop a smartphone application for cognitive behavioral therapy for the prevention of perinatal depression

Research to develop a smartphone application for cognitive behavioral therapy for the prevention of perinatal depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042240162
Enrollment
800
Registered
2025-01-07
Start date
2025-01-21
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

Pregnancy Pregnant women

Interventions

Participants are able to use the application by installing it on their smartphones from the download site and entering the ID and password provided. After completing the baseline questionnaire and att
Cognitive Behavioral Therapy

Sponsors

Goto Shinobu
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be included in the study. (1) Patients between 10 and 20 weeks of pregnancy who visited the Department of Obstetrics and Gynecology, Nagoya City University Hospital (2) Patients who own a smart phone (3) Patients who are at least 18 years old at the time of obtaining consent for participation in the study (4) Patients who have obtained written consent from the patient herself for participation in the study

Exclusion criteria

Exclusion criteria: (1) Those who have a serious physical illness that makes the use of the application impossible (2) Those who are currently diagnosed with some kind of mental illness and are visiting a hospital or receiving specialized treatment related to mental illness (3) Those who have thoughts of dying (4) Those who cannot understand Japanese description (5) Those whose doctor has deemed them unsuitable for the study

Design outcomes

Primary

MeasureTime frame
Frequency of depression (defined by EPDS higher than 9 points) at one month postpartum

Secondary

MeasureTime 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 one month 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) The Client Satisfaction Questionnaire-3 (CSQ-3), adherence to smartphone CBT, co-interventions, safety information at week 6 and 6 months postpartum.

Contacts

Public ContactChihiro Banno

Nagoya City University University Hospital

rising.help.cbt@gmail.com+81-52-853-8241

Outcome results

None listed

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