UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048562 |
|---|---|
| Receipt number | R000055209 |
| Scientific Title | Internet-based cognitive behavioral therapy to prevent paternal perinatal depression (iDadCare) |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2024/02/05 10:22:32 |
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Basic information
Public title
Internet-based cognitive behavioral therapy to prevent paternal perinatal depression (iDadCare)
Acronym
Internet-based cognitive behavioral therapy to prevent paternal perinatal depression (iDadCare)
Scientific Title
Internet-based cognitive behavioral therapy to prevent paternal perinatal depression (iDadCare)
Scientific Title:Acronym
Internet-based cognitive behavioral therapy to prevent paternal perinatal depression (iDadCare)
Region
| Japan |
Condition
Condition
Perinatal depression
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether the internet-based cognitive behavioral therapy program for perinatal fathers is effective for preventing postnatal depression among fathers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms (Edinburgh Postnatal Depression Scale; EPDS) of fathers at 12, 24 weeks after the start of the trial
Key secondary outcomes
Psychological stress(K6), Mother-to Infant Bonding Scale Japanese version; MIBS-J, parental stress, Conflict-Tactics Scale-1, intimate partner violence, trauma-informed care attitude, Ultrecht Work Engagement Scale(UWES), Fear of Coronavirus-19, implementation outcome scale for digital mental health(iOSDMH)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Internet-based cognitive behavioral therapy
Participants in the intervention group will learn weekly 7 internet sessions (requires 15 minutes per session). As a pilot study, the intervention will be conducted for 40 participants prior to the randomized controlled trial.
Interventions/Control_2
Participants in the control group can receive treatment as usual.
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
Male
Key inclusion criteria
1.Partner is pregnant at 16 weeks of gestational age or later at the time of informed consent.
2.Males aged 18 years or older at the time of informed consent.
3.Has internet access.
4.Able to understand Japanese.
Key exclusion criteria
1.Not living with his partner at the time of informed consent.
2.Being diagnosed of depression during his partner's current pregnancy.
3.Currently consulting psychiatrist.
Target sample size
788
Research contact person
Name of lead principal investigator
| 1st name | Erika |
| Middle name | |
| Last name | Obikane |
Organization
National Center for Child Health and Development, Japan
Division name
Department of Social Medicine
Zip code
1130033
Address
Okura 2-10-1, Setagayaku, Tokyo, Japan
TEL
03-3416-0181
obikane-e@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Obikane |
Organization
National Center for Child Health and Development
Division name
Department of Social Medicine
Zip code
1130033
Address
Okura 2-10-1, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
obikane-e@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
National Center for Child Health and Development
Address
Okura 2-10-1, Setagaya-ku, Tokyo, Japan
Tel
0334160181
obikane-e@ncchd.go.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
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pilot study is undergoing
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055209
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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