UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046833 |
|---|---|
| Receipt number | R000053432 |
| Scientific Title | The effects of a preventive intervention for perinatal depression -A study of the psychoeducational program utilizing the concept of sense of coherence(SOC) |
| Date of disclosure of the study information | 2022/02/05 |
| Last modified on | 2024/10/02 04:16:42 |
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Basic information
Public title
The effects of a preventive intervention for perinatal depression -A study of the psychoeducational program utilizing the concept of sense of coherence(SOC)
Acronym
The effects of a preventive intervention for perinatal depression -A study of the psychoeducational program utilizing the concept of sense of coherence(SOC)
Scientific Title
The effects of a preventive intervention for perinatal depression -A study of the psychoeducational program utilizing the concept of sense of coherence(SOC)
Scientific Title:Acronym
The effects of a preventive intervention for perinatal depression -A study of the psychoeducational program utilizing the concept of sense of coherence(SOC)
Region
| Japan |
Condition
Condition
perinatal depression
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prevention of perinatal depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale
Key secondary outcomes
SOC(sense of coherence) scale
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
(Intervention group)
psychoeducationet two times: beween 34 weeks and 40 weeks of pregnancy, one month after childbirth
Questionnaires 4 times:pretest, posttest(two weeks, one month & three months postpartum)
Interventions/Control_2
Control group/Non-psychoeducation, usual care
Questionnaires 4 times:pretest, posttest(two weeks, one month & three months postpartum)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.New moms between 34 weeks and 40weeks of gestations
2.No complications
3.Raising a baby with a partner
4.Primiparous women and their partners who agree and cooperate with the research
Key exclusion criteria
1. New mothers before 34 weeks gestations
2. With complications
3. A single parent
4. Multiparous women
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yuhei |
| Middle name | |
| Last name | Hatakenaka |
Organization
University of Ryukyus
Division name
Humanities and Social Sciences
Zip code
903-0129
Address
Chihara1 Nishihara Okinawa
TEL
098-895-8182
yuheih@hs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | Miyagi |
| Last name | McConkie |
Organization
University of the Ryukyus
Division name
Humanities and Social Sciences
Zip code
903-0129
Address
Chihara1 Nishihara Okinawa
TEL
09068645785
Homepage URL
k208034reserch@gmail.com
Sponsor or person
Institute
University of Ryukyus
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
N/A
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of University of the Ryukyus Clinical
Address
Okinawa Nakagamigun Nishihara uehara 207
Tel
0988958016 ext.8016
krinken@acs.u-ryukyu.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
当山産婦人科医院、安座間産婦人科医院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 05 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053432
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/10/02 | k208034McConkie研究計画書UMIN.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/10/02 | 研究症例データ仕様書10012024.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/10/02 | 研究データMcConkie2023.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/53432
