UMIN ID: UMIN000056014
Registered date:11/11/2024
A clinical study : Mental Health Care Application for Pregnant Women (Protocol No:NBP-24-01)
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | First-time pregnant women aged 18 years or older and under 40 years old |
| Date of first enrollment | 2024/11/11 |
| Target sample size | 330 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 to 10 minutes per day for approximately 57 days. In this study, only the questionnaire survey will be administered to the subjects in the control group. |
Outcome(s)
| Primary Outcome | Proportion of subjects with moderate to high satisfaction (CSQ-8J score is 17 or more) at Visit 5 Change in PHQ-9 score from baseline at Visit 5 |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 40years-old |
| Gender | Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Shionogi & Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Shionogi & Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takao Machitani |
| Address | Yamato Bld.1kai, 1-27-5, Nihombashikakigaracho, Chuo Ku, Tokyo To, 103-0014, Japan Japan 103-0014 |
| Telephone | 0366610858 |
| admin_studyformaternity@integrity-healthcare.co.jp | |
| Affiliation | Integrity Healthcare Co., Ltd. Digital Therapy Business Department |
| scientific contact | |
| Name | Gaku Sakaguchi |
| Address | 3-1-8, Doshomachi, Osaka Shi Chuo Ku, Osaka Fu, 541-0045, Japan Japan |
| Telephone | 08024588057 |
| gaku.sakaguchi@shionogi.co.jp | |
| Affiliation | Shionogi & Co., Ltd. New Business Promotion Department |