UMIN-CTR Clinical Trial

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