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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Enrolling by invitation |
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 | 2021/02/20 |
Basic information | ||
Public title | Behavioral activation therapy program via
smartphone for postnatal mothers and babies |
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Acronym | Behavioral activation therapy program via
smartphone for postnatal mothers and babies |
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Scientific Title | Internet-based behavioral activation
therapy via smartphone for postnatal mothers to reduce postnatal depression and child abuse: a randomized controlled trial |
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Scientific Title:Acronym | Internet-based behavioral activation
therapy via smartphone for postnatal mothers to reduce postnatal depression and child abuse: a randomized controlled trial |
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Region |
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Condition | ||
Condition | Postnatal depression
Child abuse |
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Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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)
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Target sample size | 390 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | Status: pilot study |
Management information | |||||||
Registered date |
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Last modified on |
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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 |