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 |
* 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
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
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
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
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
