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
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
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
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
