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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043822
Receipt No. R000050016
Scientific Title A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Date of disclosure of the study information 2021/04/05
Last modified on 2021/04/02

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Basic information
Public title A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Acronym A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Scientific Title A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Scientific Title:Acronym A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate an effectiveness of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Edinburgh Postnatal Depression Scale
Key secondary outcomes Patient Health Questionnaire-9,Hospital Anxiety and Depression Scale, Self-rating Depression Scale, Rate of Depression diagnosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Brief Interpersonal Psychotherapy
Interventions/Control_2 Treatment as usual
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
18 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria Perinatal women who met criteria for current major depressive disorder on the Structured Clinical Interview for DSM-5 disorders, Research Version.
Key exclusion criteria Disturbance of consciousness
Diagnosis of schizophrenia or bipolar disorder
Psychotic symptoms
Substance abuse or dependence within the preceding six months
Actively suicidal ideation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Seino
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code 6638501
Address 1-1 Mukogawa-cho Nishinomiya city Hyogo, Japan
TEL 0798456051
Email hitomi-s@hyo-med.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Seino
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code 6638501
Address 1-1 Mukogawa-cho Nishinomiya city Hyogo, Japan
TEL 0798456051
Homepage URL
Email hitomi-s@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo College of Medicine
Address 1-1 Mukogawa-cho Nishinomiya city Hyogo, Japan
Tel 0798456066
Email rinri@hyo-med.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
2021 Year 04 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 02 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050016

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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