UMIN-CTR Clinical Trial

Basic information
Public title	Behavioral activation therapy program via smartphone for postnatal mothers and babies
Acronym	Behavioral activation therapy program via smartphone for postnatal mothers and babies
Scientific Title	Internet-based behavioral activation therapy via smartphone for postnatal mothers to reduce postnatal depression and child abuse: a randomized controlled trial
Scientific Title:Acronym	Internet-based behavioral activation therapy via smartphone for postnatal mothers to reduce postnatal depression and child abuse: a randomized controlled trial
Region	Japan

Condition
Condition	Postnatal depression Child abuse
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is a clustered randomized trial which includes a six-months follow-up after intervention in multi-medical hospitals. The aim of the study is to evaluate the efficacy of internet-based behavioral activation therapy program via smartphone (Smart Mama) for postnatal mothers as follows: (1) to reduce depression symptoms (measured by Edinburgh Postnatal Depression Scale; EPDS) at 24 weeks follow-up among postnatal women with EPDS scored >=9 points compared to intervention group; (2) to reduce child abuse at 24 weeks follow-up among all postnatal women compared to intervention group. The study examines how social characteristics of participants and medical-providers influence implementation and dissemination outcomes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Edinburgh Postnatal Depression Scale at 24 weeks follow-up
Key secondary outcomes	Psychological aggression of Child Conflict Tactics Scale-1(CTS-1) at 24 weeks EPDS at 12 weeks CTS-1 at 12 weeks Parent stress index-short form Japanese version at 12 and 24 weeks Mother-to-Infant Bonding Scale Japanese version; MIBS-J at 12 and 24 weeks Quality of life(EuroQol-5 dimension-5 level; EQ-5D-5L) at 12 and 24 weeks Medical service usage and prescription data at 12 and 24 weeks Child growth outcomes (height SD, weight SD) Child nutrional status Well-baby check-up status Child immunization status In-patient and outpatient medical care for unintentional injuries, foreign body ingestion, burn, and drowning

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: participants in intervention group receive 12 sessions of behairoal activation program via smartphone and 2 assignments. They receive feedbacks from their therapists on their apps. They recive reminding e-mails when they have not completed sessions or have not turned in their assignments. They are able to receive treatment as usual (including outpatient care, psychotherapy, medication).
Interventions/Control_2	Control group: participants in control group answer baseline survey and follow-up surveys, and they recive messages on self-care via their apps. They are able to receive treatment as usual (including outpatient care, psychotherapy, medication).
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	Not applicable
Gender	Female
Key inclusion criteria	(1)Postnatal women who had delivery within 10 weeks and aged 20 years or over;(2) Has internet access via smartphone;(3) Has understood overview of the study and agrees to participate in the study
Key exclusion criteria	(1)Currently haas suicidal ideation; (2)Not living with her child due to some reason (child is hospitalized, etc)
Target sample size	390

Research contact person
Name of lead principal investigator	1st name Norito Middle name Last name Kawakami
Organization	The University of Tokyo
Division name	Department of Mental Health, Graduate School of Medicine
Zip code	113-0033
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL	03-5841-3364
Email	kawakami@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Erika Middle name Last name Obikane
Organization	The University of Tokyo
Division name	Department of Mental Health, Graduate School of Medicine
Zip code	113-0033
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL	03-5841-3364
Homepage URL
Email	healthymom@m.u-tokyo.ac.jp

Sponsor
Institute	Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Society For the Promotion of the Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Yokohama Municipal Citizen's Hospital Yokohama City University Medical Center
Name of secondary funder(s)	Seseragi Foundation

IRB Contact (For public release)
Organization	Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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	横浜市立市民病院（神奈川県）、横浜市立大学付属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 27 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	Enrolling by invitation
Date of protocol fixation	2019 Year 05 Month 14 Day
Date of IRB	2019 Year 05 Month 14 Day
Anticipated trial start date	2019 Year 09 Month 17 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Status: pilot study

Management information
Registered date	2019 Year 05 Month 27 Day
Last modified on	2021 Year 02 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041986

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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