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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036864
Receipt No. R000041986
Scientific Title Internet-based behavioral activation therapy via smartphone for postnatal mothers to reduce postnatal depression and child abuse: a randomized controlled trial
Date of disclosure of the study information 2019/05/27
Last modified on 2019/05/27

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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 Preinitiation
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 06 Month 15 Day
Last follow-up date
2020 Year 12 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 05 Month 27 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.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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