UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052049 |
|---|---|
| Receipt number | R000057551 |
| Scientific Title | Study for verifying benefits of open dialogue for pregnant women having mental problems |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/06/06 10:54:31 |
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Basic information
Public title
Open dialogue for pregnant women having mental problems
Acronym
Open dialogue for pregnant women having mental problems
Scientific Title
Study for verifying benefits of open dialogue for pregnant women having mental problems
Scientific Title:Acronym
Study for verifying benefits of open dialogue for pregnant women having mental problems
Region
| Japan |
Condition
Condition
mental health problems during the perinatal periods
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is preceding study for the clinical study. The clinical study is aimed to verify effectiveness of open dialogue for pregnant women having mental problems, compared with traditional psychiatric therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of Edinburgh Postnatal Depression Scale's change by intervention at the point of 12 months later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We would perfome Open Dialogue below once a month.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Pregnant women who have received adequate explanation of the purpose and content of this study, are able to give informed consent, voluntarily volunteer after fully understood, and agree to participate in writing.
2) Pregnant women having mental problems aged 20 to <45 years at the time of informed consent.
Key exclusion criteria
None.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Mizuno |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
910-1193
Address
23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776618363
tmykmzn@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Mizuno |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
910-1193
Address
23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776618363
Homepage URL
tmykmzn@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Tomoyuki Mizuno
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medical Sciences, University of Fukui
Address
23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776618363
tmykmzn@u-fukui.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 | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057551
