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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042570
Receipt No. R000048590
Scientific Title Construction of an online clinic system for the prevention of perinatal depression and suicide
Date of disclosure of the study information 2020/12/31
Last modified on 2020/11/27

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Basic information
Public title Construction of an online clinic system for the prevention of perinatal depression and suicide
Acronym Construction of an online clinic system for the prevention of perinatal depression and suicide
Scientific Title Construction of an online clinic system for the prevention of perinatal depression and suicide
Scientific Title:Acronym Construction of an online clinic system for the prevention of perinatal depression and suicide
Region
Japan

Condition
Condition perinatal depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Reveal the true prevalence of depression and anxiety, etc.
Identify the cutoffs and high relevance question items for rating scales in depression diagnosis
Identify obstetric and psychiatric factors associated with maternal depression and anxiety
Based on the results above, develop guidelines for screening of pregnant and nursing mothers requiring psychiatric intervention.
Clarify the usefulness of online clinic systems in perinatal care
Basic objectives2 Others
Basic objectives -Others The development of prevention and early intervention systems for perinatal depression and suicide is an urgent issue for society as a whole. Actual symptoms need to be assessed by a psychiatrist through a psychiatric diagnostic interview, but very few pregnant women see a psychiatrist.
On the other hand, the introduction of online clinics is becoming more widespread in recent years.This study constructs an online psychiatric diagnostic interview for pregnant women with anxiety and depression, while examining the true prevalence of depression and other conditions. The systematic identification and early intervention of pregnant and pregnant womens who need intervention can make a significant contribution to suicide prevention.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Psychiatric Diagnosis
Key secondary outcomes Number of referrals from obstetrics to psychiatry before/after the study

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 If the results of the psychiatric diagnostic interview indicate that psychiatric treatment is necessary, the patient and the obstetrician should be informed and psychiatric consultation should be suggested.
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria The following pregnant women who visited 10 maternity hospitals in Niigata Prefecture
A score of 8 or higher on the Hospital Anxiety and Depression scale (HADS; a measure of anxiety and depression)
Key exclusion criteria Already attending a psychiatric clinic
Those already receiving specific maternity assistance
Those taking psychotropic drugs
Disagree with the psychiatric diagnostic interview
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Koyo
Middle name
Last name Hashijiri
Organization Niigata University School of Medicine
Division name Department of Psychiatry
Zip code 951-8520
Address 1-754Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
TEL 025-227-2213
Email konokome@yahoo.co.jp

Public contact
Name of contact person
1st name Koyo
Middle name
Last name Hashijiri
Organization Niigata University School of Medicine
Division name Department of Psychiatry
Zip code 951-8520
Address 1-754Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
TEL 025-227-2213
Homepage URL
Email konokome@yahoo.co.jp

Sponsor
Institute Niigata University School of Medicine
Department of Psychiatry
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Niigata University School of Medicine
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
Tel 025-227-2213
Email isgkenkyu@adm.niigata-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 新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 31 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
2020 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 10 Day
Last follow-up date
2022 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 27 Day
Last modified on
2020 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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