UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061536 |
|---|---|
| Receipt number | R000069969 |
| Scientific Title | Effectiveness of a Mobile Application to Promote Mental Health and Parenting Role Development in Women Transitioning to Motherhood: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/12 10:59:18 |
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Basic information
Public title
The Effectiveness of Smartphone Apps in Improving Mothers'Mental Health and Parenting Roles
Acronym
Smartphone Apps That Promote Mothers'Mental Health and Parent Roles
Scientific Title
Effectiveness of a Mobile Application to Promote Mental Health and Parenting Role Development in Women Transitioning to Motherhood: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of a Mobile App on Improving Parental Mental Health-RCT-
Region
| Japan |
Condition
Condition
Mental Health
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a mobile application incorporating self-compassion and meaning in life in improving mental health and parenting role development in women transitioning to motherhood in a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
K6japaneseversion
Measurement periods 28weeks of pregnancy,32 weeks of pregnancy,1 month postpartum,3 months postpartum
Key secondary outcomes
Prenatal Attachment Inventory ,Maternal Attachment Inventory,Parenting Sense of Competence Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The intervention group will use a journaling app designed to help them reflect on self-compassion and the meaning of parenthood for five weeks.
Interventions/Control_2
The control group will continue their pregnancy as usual. The app will be provided three months after childbirth.
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
Adult women aged 18 years or older who are pregnant with their first child
Pregnant women with an uncomplicated pregnancy
Pregnant women at the start of the intervention (28 weeks 0 days to less than 34 weeks of gestation) and at the end of the intervention (33 weeks 0 days to less than 39 weeks of gestation)
Able to understand, read, and write Japanese
No history of treatment for mental illness and not currently receiving treatment
Key exclusion criteria
Women with multiple pregnancies
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Kimura |
Organization
Nara Medical University
Division name
Graduate School of Nursing
Zip code
6348521
Address
88 Shijo-cho, Kashihara City, Nara Prefecture
TEL
08015036550
nao1710@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Kimura |
Organization
Nara Medical University
Division name
Graduate School of Nursing
Zip code
6348521
Address
88 Shijo-cho, Kashihara City, Nara Prefecture
TEL
08015036550
Homepage URL
nao1710@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Naomi Kimura
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethiks Committee
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744223051
ino_rinri@naramed-u.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
| 2026 | Year | 05 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 05 | Month | 12 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069969
