UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043822
Receipt number 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 2022/04/03 14:00:23

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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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2021 Year 04 Month 05 Day

Date of IRB

2021 Year 06 Month 11 Day

Anticipated trial start date

2021 Year 06 Month 11 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

2022 Year 04 Month 03 Day



Link to view the page

Value
https://center6.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