UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038847
Receipt No. R000044263
Scientific Title Development of the psycho-education program of postnatal depressive symptoms and behavioral activation
Date of disclosure of the study information 2019/12/11
Last modified on 2019/12/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Development of the psycho-education program of postnatal depressive symptoms and behavioral activation
Acronym Behavioral activation for the prevention of postnatal depression
Scientific Title Development of the psycho-education program of postnatal depressive symptoms and behavioral activation
Scientific Title:Acronym Behavioral activation for the prevention of postnatal depression
Region
Japan

Condition
Condition Depression,Postnatal Depression
Classification by specialty
Obsterics and gynecology Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We carry out the behavioral activation psychological program using SNS for the women within one year after giving birth, and examine the effect of it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Edinburgh Postnatal Depression Scale(Japanese Version; EPDS)
Key secondary outcomes Behavioral Activation for Depression Scale
Environmental Reward Observation Scale

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 We conduct a 7-day psycho-education program for behavioral activation using SNS.
Interventions/Control_2 No treatment
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
20 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria (a)An adult woman who is within one year after giving birth,
(b)Informed consent.
Key exclusion criteria (a) If there is a physical problem with the fetus or the person during this pregnancy, (b) If they have experienced miscarriage or stillbirth, (c)If they have a history of mental illness, (d) if they have experienced of family or friendship death, illness or accident during this pregnancy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Miki
Middle name
Last name Matsunaga
Organization Rikkyo University
Division name Department of Psychology
Zip code 3528558
Address 1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL 048-471-6901
Email mikim@rikkyo.ac.jp

Public contact
Name of contact person
1st name Miki
Middle name
Last name Matsunaga
Organization Rikkyo University
Division name Department of Psychology
Zip code 3528558
Address 1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL 048-471-6901
Homepage URL
Email mikim@rikkyo.ac.jp

Sponsor
Institute Rikkyo University
Institute
Department

Funding Source
Organization Rikkyo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Rikkyo University
Address 3-34-1, NishiIkebukuro, Toshima, Tokyo
Tel 03-3985-4589
Email lifescience@rikkyo.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 愛和病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 11 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 09 Day
Date of IRB
2019 Year 12 Month 07 Day
Anticipated trial start date
2019 Year 12 Month 12 Day
Last follow-up date
2020 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
2019 Year 12 Month 11 Day
Last modified on
2019 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044263

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.