UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicentre randomized controlled trial on the effects of a preventive intervention of postpartum interpersonal relationships disorder (PIRD)
Title of the study (Brief title)	Effects of a preventive intervention of PIRD
Region	Japan

Condition
Condition	Pregnant
Classification by specialty	Psychosomatic Internal Medicine Obsterics 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	Toshinori Kitamura
Organization	Kitamura Institute of Mental Health Tokyo
Division name	dean
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	Toshinori Kitamura
Organization	The Kintamura Institute of Mental Health Tokyo
Division name	dean
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
Institute	Kitamura Institute of Mental Health Tokyo
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 04 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022044