UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054561 |
|---|---|
| Receipt number | R000062144 |
| Scientific Title | The Effectiveness of Mobile Applications for Preventing Antenatal Depression Among Pregnant Women |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/06/04 12:26:08 |
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Basic information
Public title
The Effectiveness of Mobile Application for Preventing Antenatal Depression Among Pregnant Women
Acronym
The Effectiveness of Mobile Applications for Preventing Antenatal Depression Among Pregnant Women
Scientific Title
The Effectiveness of Mobile Applications for Preventing Antenatal Depression Among Pregnant Women
Scientific Title:Acronym
The Effectiveness of Mobile Applications for Preventing Antenatal Depression Among Pregnant Women
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the effectiveness of a mobile application to preventing antenatal depression among pregnant women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement scale for depression: Patient Health Questionnaire-9 (PHQ-9) Japanese version. The evaluation will be conducted starting from the mid-pregnancy period (baseline) before the intervention of the app and will be reassessed at the end of pregnancy after the app usage.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
For the intervention group (aimed at preventing depression among pregnant women) mobile application use group
Interventions/Control_2
Mobile application use group for control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women in the second trimester (16-27 weeks gestation)
Pregnant women who have given consent to use their own web environment and to use mobile applications
Key exclusion criteria
Pregnant women with a history of mental illness
Pregnant women whose native language is not Japanese
Pregnant women who do not reside in Japan
Pregnant women who require hospitalization
Pregnant women who are deemed unsuitable by the Principal Investigator or a Research Supervisor, such as those who are unable to understand how to operate the application.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Manaka |
Organization
Osaka Medical and Pharmaceutical University
Division name
faculty of nursing
Zip code
5690095
Address
7-6 Hatconishimachi, Takatsuki, Osaka, Japan
TEL
0726831221
maiko.manaka@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Manaka |
Organization
Osaka Medical and Pharmaceutical University
Division name
faculty of nursing
Zip code
5690095
Address
7-6 Hatconishimachi, Takatsuki, Osaka, Japan
TEL
0726831221
Homepage URL
maiko.manaka@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty Of Nursing, Osaka Medical And Pharmaceutical University
Address
7-6 Hatconishimachi, Takatsuki, Osaka, Japan
Tel
0726831221
maiko.manaka@ompu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062144
