Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.
This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.
The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.
jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).
Although some research supports the maintenance of positive outcomes from cardiac rehabilitation Phase II (CR II) up to 12 months, the barriers to maintaining physical activity and risk factor management during CR maintenance (CR III) are well known.
To investigate participants' ability to sustain clinical, quality-of-life (QOL), and behavioral outcomes and share their experiences 6 months after CR II completion.
Longitudinal explanatory sequential pre-CR/post-CR study in a community hospital within a large health system. A convenience sample of 155 participants completed a reassessment of health outcomes. Participants also completed an online survey about barriers and facilitators during and after CR II. Analysis methods included MANOVA and summative content analysis.
The sample was mostly male, white, non-Hispanic, and college educated, with a mean age of 67.9 years. CR II participants sustained most behavioral outcomes, but not all clinical outcomes. Outcomes that improved/maintained were physical activity, tobacco status, diet, and QOL. Outcomes that worsened/returned to pre-CR II were weight, blood pressure, and depression. Participants described their motivation for staying healthy, top concerns, goals, barriers, and strengths/resources. Common responses included exercise, weight, diet, quality of life, family, and friends.
Our findings suggest the need for the implementation of innovative strategies during CR II that may extend past discharge into CR III. These include the introduction of digital technology and eHealth to provide value-added service to patients and a solid foundation for future maintenance and a structured, behavioral weight loss intervention. Establishing these tools, in addition to developing a support system will help patients to initiate maintenance care before program completion.