Title
Internet-based behavioural activation to improve depressive symptoms and prevent child abuse in postnatal women (SmartMama): a protocol for a pragmatic randomized controlled trial
Date Issued
01 December 2021
Access level
open access
Resource Type
journal article
Author(s)
Obikane E.
Baba T.
Shinozaki T.
Obata S.
Nakanishi S.
Murata C.
Ushio E.
Suzuki Y.
Shirakawa N.
Honda M.
Sasaki N.
Nishi D.
O’Mahen H.
Kawakami N.
Publisher(s)
BioMed Central Ltd
Abstract
Background: Child abuse and postnatal depression are two public health problems that often co-occur, with rates of childhood maltreatment highest during the first year of life. Internet-based behavioural activation (iBA) therapy has demonstrated its efficacy for improving postnatal depression. No study has examined whether the iBA program is also effective at preventing child abuse. This study aims to investigate whether iBA improves depressive symptoms among mothers and prevents abusive behaviours towards children in postpartum mothers in a randomized controlled trial, stratifying on depressive mood status. The study also evaluates the implementation aspects of the program, including how users, medical providers, and managers perceive the program in terms of acceptability, appropriateness, feasibility, and harm done. Methods: The study is a non-blinded, stratified randomized controlled trial. Based on cut-off scores validated on Japanese mothers, participants will be stratified to either a low Edinburgh Postnatal Depression Scale (EPDS) group, (EPDS 0–8 points) or a high EPDS group (EPDS ≥9 points). A total of 390 postnatal women, 20 years or older, who have given birth within 10 weeks and have regular internet-access will be recruited at two hospitals. Participants will be randomly assigned to either treatment, with treatment as usual (TAU) or through intervention groups. The TAU group receives 12 weekly iBA sessions with online assignments and feedback from trained therapists. Co-primary outcomes are maternal depressive symptoms (EPDS) and psychological aggression toward children (Conflict Tactic Scale 1) at the 24-week follow-up survey. Secondary outcomes include maternal depressive symptoms, parental stress, bonding relationship, quality of life, maternal health care use, and paediatric outcomes such as physical development, preventive care attendance, and health care use. The study will also investigate the implementation outcomes of the program. Discussion: The study investigates the effectiveness of the iBA program for maternal depressive symptoms and psychological aggression toward children, as well as implementation outcomes, in a randomized-controlled trial. The iBA may be a potential strategy for improving maternal postnatal depression and preventing child abuse. Trial registration: The study protocol (issue date: 2019-Mar-01, original version 2019005NI-00) was registered at the UMIN Clinical Trial Registry (UMIN-CTR: ID UMIN 000036864).
Volume
21
Issue
1
Language
English
OCDE Knowledge area
Psiquiatría
Scopus EID
2-s2.0-85104577919
PubMed ID
Source
BMC Pregnancy and Childbirth
Sponsor(s)
Development and management of iBA smartphone programs, and recruitment cost were founded by the Grant-in-Aid for Young Scientists (B) 2017 (Grant number: 17 K15848) from Japan Society for the Promotion of Science. Recruitment and trial equipment were partially funded by Seseragi Foundation, Japan. Maintenance cost of internet server, publication fees and equipment were also supported by internal funding of National Center for Global Health and Medicine, Japan. The funding sources had no role in the study design and will not have any role during recruitment, data collection, analyses, or submission of the results.
Sources of information: Directorio de Producción Científica Scopus