UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019064
Receipt number R000022044
Scientific Title Multicentre randomized controlled trial on the effects of a preventive intervention of postpartum interpersonal relationships disorder (PIRD)
Date of disclosure of the study information 2015/10/01
Last modified on 2017/04/18 17:09:55

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Basic information

Public title

Multicentre randomized controlled trial on the effects of a preventive intervention of postpartum interpersonal relationships disorder (PIRD)

Acronym

Effects of a preventive intervention of PIRD

Scientific Title

Multicentre randomized controlled trial on the effects of a preventive intervention of postpartum interpersonal relationships disorder (PIRD)

Scientific Title:Acronym

Effects of a preventive intervention of PIRD

Region

Japan


Condition

Condition

Pregnant

Classification by specialty

Psychosomatic Internal Medicine Obstetrics and Gynecology Nursing
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of a continuous perinatal group intervention program designed to prevent the postpartum depression and other interpersonal relationships disorder.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Postpartum depression,
5 days and 1 months after delivery,
Edinburgh Postnatal Depression Scale(EPDS),
Structured Clinical Interview for DSM-IV (SCID)

Key secondary outcomes

Bonding toward the infant,
5 days and 1 months after delivery,
Japanese version of the Mother-to-Infant Bonding Scale (MIBS-J)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Group A (Intervention Group)
Group counseling program toward pregnant women.
1 group consists of 7-8 pregnant women and 2 facilitators.
1 program is consist of 5 continuous group sessions during pregnancy to postpartum. (Sessions are held monthly.)
Each session includes following theme,
Session 1
Introduction and psychological education.
Session 2
Change of the role, how to acquire support, enjoyment list.
Session 3
Interpersonal management, relaxation, assertion.
Session 4
Assertion, goal setting.
Session 5
Review and summary, bonding, grief.

Interventions/Control_2

Group B (Control Group)
Group Video education program toward pregnant women.
1 group consists of 7-8 pregnant women and 1-2 facilitators.
1 program is consist of 5 continuous group sessions during pregnancy to postpartum. (Sessions are held monthly.)
Each session provide following information related to pregnancy or child rearing to the participants
Session 1
Dietary education during pregnancy,
Session 2
Body change after delivery
Session 3
Growth of the infancy
Session 4
How to handle both of childcare and house chore
Session 5
Prevention of child accidental injury

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

(1) Less than gestation 16 week, (2) The fetus is singleton, (3) Expected to visit the hospital continuously for the maternity check-ups and deliver at the hospital, (3) Japanese

Key exclusion criteria

(1) Severe physical illness, (2) Lack of Japanese literacy

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshinori Kitamura

Organization

Kitamura Institute of Mental Health Tokyo

Division name

dean

Zip code


Address

Flat A, Riverlandhouse Tomigaya, 2-26-3, Tomigaya, Shibuya, Tokyo, Japan 151-0063

TEL

03-5738-8371

Email

kitamura@institute-of-mental-health.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshinori Kitamura

Organization

The Kintamura Institute of Mental Health Tokyo

Division name

dean

Zip code


Address

Flat A, Riverlandhouse Tomigaya, 2-26-3, Tomigaya, Shibuya, Tokyo, Japan 151-0063

TEL

03-5738-8371

Homepage URL


Email

kitamura@institute-of-mental-health.jp


Sponsor or person

Institute

Kitamura Institute of Mental Health Tokyo

Institute

Department

Personal name



Funding Source

Organization

Kitamura Institute of Mental Health Tokyo

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


Address


Tel


Email



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

国立病院機構 甲府病院、埼玉医科大学総合医療センター 総合周産期母子医療センター、山王病院、順天堂医院、順天堂大学医学部附属順天堂練馬病院、社会福祉法人聖母会 聖母病院


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 01 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

Date of protocol fixation

2015 Year 04 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Mizuki Takegata, Yukiko Ohashi, Megumi Haruna, Toshinori Kitamura. Theoretical Framework for Interpersonal Psychotherapy in the Prevention of Postpartum Depression: A Commentary. International Journal of Nursing and Health Science.


Management information

Registered date

2015 Year 09 Month 18 Day

Last modified on

2017 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022044


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name