Internet-based behavioural activation to improve depressive symptoms and prevent child abuse in postnatal women (SmartMama): a protocol for a pragmatic randomized controlled trial.

Internet-based behavioural activation to improve depressive symptoms and prevent child abuse in postnatal women (SmartMama): a protocol for a pragmatic randomized controlled trial.
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DOI:
10.1186/s12884-021-03767-9
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发表时间:
2021-04-20
影响因子:
3.1
通讯作者:
Kawakami N
Kawakami N
中科院分区:
医学3区
文献类型:
--
作者:
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

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虐待儿童和产后抑郁症是两个经常同时发生的公共卫生问题,儿童虐待率在生命的第一年最高。基于互联网的行为激活(iBA)疗法已证明其改善产后抑郁症的疗效。没有研究调查iBA计划是否也能有效防止虐待儿童。本研究旨在调查iBA是否改善母亲的抑郁症状,并在一项随机对照试验中预防产后母亲对儿童的虐待行为,对抑郁情绪状态进行分层。该研究还评估了该计划的实施方面,包括用户,医疗提供者和管理人员如何看待该计划的可接受性,适当性,可行性和造成的伤害。本研究是一项非盲、分层随机对照试验。根据在日本母亲中验证的临界评分,将受试者分层为低爱丁堡产后抑郁量表(EPDS)组(EPDS 0-8分)或高EPDS组(EPDS ≥9分)。将在两家医院招募390名20岁或20岁以上的产后妇女,她们在10周内分娩,并定期上网。受试者将被随机分配至任一治疗组,常规治疗(TAU)或干预组。TAU组每周接受12次iBA课程,包括在线作业和训练有素的治疗师的反馈。共同主要结局是24周随访调查时的母亲抑郁症状(EPDS)和对儿童的心理攻击(冲突策略量表1)。次要结局包括孕产妇抑郁症状、父母压力、亲密关系、生活质量、孕产妇保健使用和儿科结局,如身体发育、预防保健出勤率和保健使用。该研究还将调查该方案的执行结果。该研究调查了iBA计划对母亲抑郁症状和对儿童的心理攻击的有效性,以及在随机对照试验中的实施结果。iBA可能是改善母亲产后抑郁症和预防虐待儿童的潜在策略。研究方案(发布日期:2019年3月1日,原始版本2019005 NI-00)已在UMIN临床试验注册中心注册(UMIN-CTR:ID UMIN 000036864)。
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. 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. 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. 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).
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