UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036864
Receipt number 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 2023/02/10 18:25:48

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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 or person

Institute

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

Institute

Department

Personal name



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

Completed

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

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 05 Month 27 Day

Last modified on

2023 Year 02 Month 10 Day



Link to view the page

Value
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