First-time pregnant women aged 18 years or older and under 40 years old
Conditions
Interventions
In this study, subjects in the app usage group are instructed to install the app on their own smartphones in accordance with the app installation support manual, and to use the app for approximately 5
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Able to electronically obtain voluntary consent to participate in the study from the individual. 2. A primiparous woman aged 18 years or older and under 40 years old at the time of obtaining consent. 3. Between 16 and 28 weeks and 6 days pregnant at the time of obtaining consent. 4. Have a partner or spouse, including a common-law marriage. 5. Have basic reading and writing skills in Japanese and can use the app and answer questionnaires without any problems.
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment at a psychiatric or psychosomatic clinic (regardless of past medical history) 2. Pre-screening PHQ-9 score of 2 or more on item 9 of the PHQ-9 questionnaire indicates suicidal ideation 3. Not having a partner or spouse, or pregnant with someone other than a partner or spouse 4. Other cases where a medical advisor has determined that participation in this study is inappropriate based on concomitant medications or medical findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects in the intervention group with moderate to high satisfaction (CSQ-8J score is 17 or more) at Visit 5 (CSQ-8J administered only in the intervention group) Change in PHQ-9 score from baseline at Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects showing medium to high satisfaction level (CSQ-8J score is 17 or more) at Visit 6 Change in CSQ-8 score at Visit 6 from Visit 5 Change in PHQ-9 score from baseline at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6 Amount of change in EPDS score from baseline at Visit 5 and Visit 6 Change in ECR-RS score from baseline at Visit 5 and Visit 6 | — |
Countries
Japan
Contacts
Public ContactShinsuke Asao
Integrity Healthcare Co., Ltd. Digital Therapy Business Department
Outcome results
None listed