UMIN-CTR Clinical Trial

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	Completed
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	2020 Year 12 Month 10 Day

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