IntroductionThe objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive–behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.Methods and analysisThe target study population will be pregnant women of 16–20 weeks gestation who are currently users of ‘Luna Luna Baby’, the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.Ethics and disseminationThe study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.Trial registration numberUMIN000038190; Pre-results.
Background Digital mental health interventions are being used more than ever for the prevention and treatment of psychological problems. Optimizing the implementation aspects of digital mental health is essential to deliver the program to populations in need, but there is a lack of validated implementation outcome measures for digital mental health interventions. Objective The primary aim of this study is to develop implementation outcome scales of digital mental health for different levels of stakeholders involved in the implementation process: users, providers, and managers or policy makers. The secondary aim is to validate the developed scale for users. Methods We developed English and Japanese versions of the implementation outcome scales for digital mental health (iOSDMH) based on the literature review and panel discussions with experts in implementation research and web-based psychotherapy. The study developed acceptability, appropriateness, feasibility, satisfaction, and harm as the outcome measures for users, providers, and managers or policy makers. We conducted evidence-based interventions via the internet using UTSMeD, a website for mental health information (N=200). Exploratory factor analysis (EFA) was conducted to assess the structural validity of the iOSDMH for users. Satisfaction, which consisted of a single item, was not included in the EFA. Results The iOSDMH was developed for users, providers, and managers or policy makers. The iOSDMH contains 19 items for users, 11 items for providers, and 14 items for managers or policy makers. Cronbach α coefficients indicated intermediate internal consistency for acceptability (α=.665) but high consistency for appropriateness (α=.776), feasibility (α=.832), and harm (α=.777) of the iOSDMH for users. EFA revealed 3-factor structures, indicating acceptability and appropriateness as close concepts. Despite the similarity between these 2 concepts, we inferred that acceptability and appropriateness should be used as different factors, following previous studies. Conclusions We developed iOSDMH for users, providers, and managers. Psychometric assessment of the scales for users demonstrated acceptable reliability and validity. Evaluating the components of digital mental health implementation is a major step forward in implementation science.
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).
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