UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042570 |
|---|---|
| Receipt number | 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 10:07:43 |
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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
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
konokome@yahoo.co.jp
Sponsor or person
Institute
Niigata University School of Medicine
Department of Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048590
