UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051884 |
|---|---|
| Receipt number | R000058421 |
| Scientific Title | A Randomized Controlled Trial of Improving Fathers' Empathy Skills to Prevent Postpartum Depression in Mothers |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2026/08/17 13:54:22 |
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Basic information
Public title
A Randomized Controlled Trial of Improving Fathers' Empathy Skills to Prevent Postpartum Depression in Mothers
Acronym
A Randomized Controlled Trial of Improving Fathers' Empathy Skills to Prevent Postpartum Depression in Mothers
Scientific Title
A Randomized Controlled Trial of Improving Fathers' Empathy Skills to Prevent Postpartum Depression in Mothers
Scientific Title:Acronym
A Randomized Controlled Trial of Improving Fathers' Empathy Skills to Prevent Postpartum Depression in Mothers
Region
| Japan |
Condition
Condition
Postpartum Depression
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of an empathy skills improvement program for fathers in preventing postpartum depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postpartum depression
Key secondary outcomes
Mothers' empathy and assertion skills, mothers' loneliness, mothers' bonding to their babies, marital satisfaction, frequency of marital fights, fathers' empathy skills, mothers' somatic complaints, hostile and benevolent sexism
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Empathy Skills Teaching Statement
Interventions/Control_2
Postpartum Depression Prevention Pamphlet
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Family where mother and child were discharged 6 days postpartum and the father came to pick up the child.
Key exclusion criteria
Under 18 years old, unable to read and write Japanese
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | N/A |
| Last name | Morita |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Promotion
Zip code
113-8540
Address
1-5-45 Yushima Bunkyo-ku, Tokyo
TEL
+81358035189
morita.hlth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | N/A |
| Last name | Morita |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Promotion
Zip code
113-8540
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81358035189
Homepage URL
morita.hlth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8540
Tel
+81358035189
morita.hlth@tmd.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
| 2023 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.71063
Publication of results
Published
Result
URL related to results and publications
https://obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.71063
Number of participants that the trial has enrolled
514
Results
Sociodemographic variables were comparable between study arms. Maternal postpartum depression (EPDS 9 or higher) was 4.5% in the intervention group and 9.3% in the control groups (adjusted odds ratio [aOR] 0.45; 95% confidence interval [CI]: 0.14,1.50).
Results date posted
| 2026 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 05 | Month | 11 | Day |
Baseline Characteristics
Eligible couples were recruited during the postpartum stay if the mother had a full-term birth and no psychiatric history.
Participant flow
From October 2023 to November 2024, 262 fathers were enrolled and randomly assigned to the intervention or control group. The brief online intervention was delivered at 1 month postpartum. Follow-up assessments were conducted at 3 months (n = 221) and 6 months (n = 220).
Adverse events
None
Outcome measures
The primary outcome was maternal depressive symptoms (Japanese version of the Edinburgh Postnatal Depression Scale [EPDS]).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058421
