• Optimising internet-based cogn...

*Result*: Optimising internet-based cognitive-behavioural therapy programme to prevent perinatal depression: a unified protocol for two harmonised randomised controlled trials.

Title:
Optimising internet-based cognitive-behavioural therapy programme to prevent perinatal depression: a unified protocol for two harmonised randomised controlled trials.
Authors:
Toyomoto R; Department of Health Promotion and Behavioral Sciences, Kyoto University, Kyoto, Japan rie.toyomoto@gmail.com., Furukawa TA; Office of Institutional Advancement and Communications, Kyoto University, Kyoto, Japan., Noma H; Department of Interdisciplinary Statistical Mathematics, The Institute of Statistical Mathematics, Tokyo, Japan., Tajika A; Department of Health Promotion and Behavioral Sciences, Kyoto University, Kyoto, Japan., Watanabe M; Adachi Hospital, Kyoto, Japan., Honda Y; Department of Social Epidemiology, Kyoto University School of Public Health, Kyoto, Japan., Banno C; Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Ogasawara S; Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Kitaori T; Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Sugiura-Ogasawara M; Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Goto S; Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Source:
BMJ open [BMJ Open] 2026 Feb 18; Vol. 16 (2), pp. e099326. Date of Electronic Publication: 2026 Feb 18.
Publication Type:
Journal Article; Clinical Trial Protocol
Language:
English
Journal Info:
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Imprint Name(s):
Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
MeSH Terms:
Cognitive Behavioral Therapy*/methods , Depression, Postpartum*/prevention & control , Depression*/prevention & control , Pregnancy Complications*/prevention & control , Internet-Based Intervention*, Humans ; Female ; Pregnancy ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic ; Adult ; Internet
Contributed Indexing:
Keywords: Depression & mood disorders; Maternal medicine; Preventive Health Services; Psychosocial Intervention
Entry Date(s):
Date Created: 20260218 Date Completed: 20260218 Latest Revision: 20260221
Update Code:
20260221
PubMed Central ID:
PMC12918657
DOI:
10.1136/bmjopen-2025-099326
PMID:
41708168
Database:
MEDLINE

*Further Information*

*Introduction: 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.
Methods and Analysis: 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.
Ethics and Dissemination: 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.
Trial Registration Number: jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).
(© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)*

*Competing interests: TAF reports personal fees from Daiichi Sankyo, DT Axis, Micron, Shionogi, SONY and UpToDate, and a grant from DT Axis, outside the submitted work; In addition, TAF has a patent 7448125 and a pending patent 2024-521973, and has licensed intellectual properties for Kokoro-app to DT Axis. AT reports personal fees from Eisai and Shionogi outside the submitted work. HN received research grant form Glaxo Smith Kline, outside the submitted work. The remaining authors declare that they have no conflicts of interest.*