{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T03:55:29Z","timestamp":1772855729483,"version":"3.50.1"},"reference-count":41,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"unspecified","delay-in-days":17,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"crossref","award":["24dk0307127h0001"],"award-info":[{"award-number":["24dk0307127h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"crossref","award":["24hma922020h0001"],"award-info":[{"award-number":["24hma922020h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,4]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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\u2013behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u2019 baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1\u2009month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-099326","type":"journal-article","created":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T15:16:42Z","timestamp":1772810202000},"page":"e099326","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Optimising internet-based cognitive\u2013behavioural therapy programme to prevent perinatal depression: a unified protocol for two harmonised randomised controlled trials"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1125-3145","authenticated-orcid":false,"given":"Rie","family":"Toyomoto","sequence":"first","affiliation":[{"name":"Department of Health Promotion and Behavioral Sciences, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2159-3776","authenticated-orcid":false,"given":"Toshi A","family":"Furukawa","sequence":"additional","affiliation":[{"name":"Office of Institutional Advancement and Communications, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2520-9949","authenticated-orcid":false,"given":"Hisashi","family":"Noma","sequence":"additional","affiliation":[{"name":"Department of Interdisciplinary Statistical Mathematics, The Institute of Statistical Mathematics, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aran","family":"Tajika","sequence":"additional","affiliation":[{"name":"Department of Health Promotion and Behavioral Sciences, Kyoto University, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miki","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Adachi Hospital, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8337-1549","authenticated-orcid":false,"given":"Yukiko","family":"Honda","sequence":"additional","affiliation":[{"name":"Department of Social Epidemiology, Kyoto University School of Public Health, Kyoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-6167-8628","authenticated-orcid":false,"given":"Chihiro","family":"Banno","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-6110-8106","authenticated-orcid":false,"given":"Sakura","family":"Ogasawara","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-6092-8655","authenticated-orcid":false,"given":"Tamao","family":"Kitaori","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2265-377X","authenticated-orcid":false,"given":"Mayumi","family":"Sugiura-Ogasawara","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8217-4757","authenticated-orcid":false,"given":"Shinobu","family":"Goto","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,2,18]]},"reference":[{"key":"2026021807101138000_16.2.e099326.1","doi-asserted-by":"crossref","DOI":"10.1038\/s41398-021-01663-6","article-title":"Mapping global prevalence of depression among postpartum women","volume":"11","author":"Wang","year":"2021","journal-title":"Transl Psychiatry"},{"key":"2026021807101138000_16.2.e099326.2","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2020.8783","article-title":"Risk of Depression in the Adolescent and Adult Offspring of Mothers With Perinatal Depression: A Systematic Review and Meta-analysis","volume":"3","author":"Tirumalaraju","year":"2020","journal-title":"JAMA Netw Open"},{"key":"2026021807101138000_16.2.e099326.3","doi-asserted-by":"crossref","first-page":"1082","DOI":"10.1001\/jamapediatrics.2020.2910","article-title":"Association Between Maternal Perinatal Depression and Anxiety and Child and Adolescent Development: A Meta-analysis","volume":"174","author":"Rogers","year":"2020","journal-title":"JAMA Pediatr"},{"key":"2026021807101138000_16.2.e099326.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02141-3"},{"key":"2026021807101138000_16.2.e099326.5","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20860"},{"key":"2026021807101138000_16.2.e099326.6","doi-asserted-by":"crossref","first-page":"500","DOI":"10.1016\/S2215-0366(21)00077-8","article-title":"Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data","volume":"8","author":"Furukawa","year":"2021","journal-title":"Lancet Psychiatry"},{"key":"2026021807101138000_16.2.e099326.7","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-clinpsy-050817-084746"},{"key":"2026021807101138000_16.2.e099326.8","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/j.jad.2022.11.024","article-title":"Prognostic factors and effect modifiers for personalisation of internet-based cognitive behavioural therapy among university students with subthreshold depression: A secondary analysis of a factorial trial","volume":"322","author":"Toyomoto","year":"2023","journal-title":"J Affect Disord"},{"key":"2026021807101138000_16.2.e099326.9","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1001\/jamapsychiatry.2020.4364","article-title":"Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis","volume":"78","author":"Karyotaki","year":"2021","journal-title":"JAMA Psychiatry"},{"key":"2026021807101138000_16.2.e099326.10","doi-asserted-by":"crossref","DOI":"10.2196\/jmir.8602","article-title":"Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial","volume":"19","author":"Mantani","year":"2017","journal-title":"J Med Internet Res"},{"key":"2026021807101138000_16.2.e099326.11","doi-asserted-by":"crossref","first-page":"e18","DOI":"10.1136\/ebmental-2022-300455","article-title":"Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: a factorial trial","volume":"25","author":"Sakata","year":"2022","journal-title":"Evid Based Ment Health"},{"key":"2026021807101138000_16.2.e099326.12","doi-asserted-by":"crossref","first-page":"1830","DOI":"10.1038\/s41591-025-03639-1","article-title":"Cognitive behavioral therapy skills via a smartphone app for subthreshold depression among adults in the community: the RESiLIENT randomized controlled trial","volume":"31","author":"Furukawa","year":"2025","journal-title":"Nat Med"},{"key":"2026021807101138000_16.2.e099326.13","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9343(87)90061-1"},{"key":"2026021807101138000_16.2.e099326.14","doi-asserted-by":"publisher","DOI":"10.4992\/jjpsy.83.91"},{"key":"2026021807101138000_16.2.e099326.15","doi-asserted-by":"crossref","DOI":"10.3389\/fpsyg.2022.862646","article-title":"Validation of the Japanese Big Five Scale Short Form in a University Student Sample","volume":"13","author":"Toyomoto","year":"2022","journal-title":"Front Psychol"},{"key":"2026021807101138000_16.2.e099326.16","doi-asserted-by":"publisher","DOI":"10.1016\/S0749-3797(98)00017-8"},{"key":"2026021807101138000_16.2.e099326.17","unstructured":"Tsuboi S . Creating a Japanese Version Adverce Childhood Experiences Score Calculator. Grant-in-Aid for Scientific Research Report, 2014."},{"key":"2026021807101138000_16.2.e099326.18","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1016\/j.jpsychores.2014.03.010","article-title":"Providing patient progress feedback and clinical support tools to therapists: is the therapeutic process of patients on-track to recovery enhanced in psychosomatic in-patient therapy under the conditions of routine practice?","volume":"76","author":"Probst","year":"2014","journal-title":"J Psychosom Res"},{"key":"2026021807101138000_16.2.e099326.19","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1136\/ebmental-2020-300217","article-title":"Development and validation of the Cognitive Behavioural Therapy Skills Scale among college students","volume":"24","author":"Sakata","year":"2021","journal-title":"Evid Based Ment Health"},{"key":"2026021807101138000_16.2.e099326.20","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m4022","article-title":"Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression among pregnant and postpartum women: systematic review and meta-analysis of individual participant data","volume":"371","author":"Levis","year":"2020","journal-title":"BMJ"},{"key":"2026021807101138000_16.2.e099326.21","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291700033237"},{"key":"2026021807101138000_16.2.e099326.22","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1002\/mpr.1437","article-title":"One-year test-retest reliability of a Japanese web-based version of the WHO Composite International Diagnostic Interview (CIDI) for major depression in a working population","volume":"24","author":"Shimoda","year":"2015","journal-title":"Int J Methods Psychiatr Res"},{"key":"2026021807101138000_16.2.e099326.23","unstructured":"Munezawa T , Morin C , Inoue Y . Development of the japanese version of the insomnia severity index (ISI-J) seishinkachiryogaku. 2009."},{"key":"2026021807101138000_16.2.e099326.24","first-page":"15","article-title":"Perceptions of Equity in the Division of Household Labor","volume":"10","author":"Moroi","year":"1996","journal-title":"Japanese Journal of Family Psychology"},{"key":"2026021807101138000_16.2.e099326.25","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1007\/s00737-012-0291-1","article-title":"A Japanese version of Mother-to-Infant Bonding Scale: factor structure, longitudinal changes and links with maternal mood during the early postnatal period in Japanese mothers","volume":"15","author":"Yoshida","year":"2012","journal-title":"Arch Womens Ment Health"},{"key":"2026021807101138000_16.2.e099326.26","doi-asserted-by":"publisher","DOI":"10.1016\/0149-7189(82)90074-X"},{"key":"2026021807101138000_16.2.e099326.27","doi-asserted-by":"publisher","DOI":"10.4992\/jjpsy.67.61"},{"key":"2026021807101138000_16.2.e099326.28","first-page":"525","article-title":"Validation and reliability of a Japanese version of the EPDS (Edinburgh Postnatal Depression Scale)","volume":"7","author":"Masuji","year":"1996","journal-title":"Archives of Psychiatric Diagnostics and Clinical Evaluation"},{"key":"2026021807101138000_16.2.e099326.29","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-0327(99)00108-1"},{"key":"2026021807101138000_16.2.e099326.30","doi-asserted-by":"publisher","DOI":"10.2307\/351302"},{"key":"2026021807101138000_16.2.e099326.31","unstructured":"Fleiss JL . Design and Analysis of Clinical. Experiments: Wiley, 2011."},{"key":"2026021807101138000_16.2.e099326.32","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2022-067850","article-title":"Four 2\u00d72 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community-RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol","volume":"13","author":"Furukawa","year":"2023","journal-title":"BMJ Open"},{"key":"2026021807101138000_16.2.e099326.33","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4067"},{"key":"2026021807101138000_16.2.e099326.35","doi-asserted-by":"crossref","unstructured":"Little RJ , Rubin DB . Statistical Analysis with Missing Data. John Wiley & Sons, 2019.","DOI":"10.1002\/9781119482260"},{"key":"2026021807101138000_16.2.e099326.36","doi-asserted-by":"publisher","DOI":"10.1081\/BIP-100104194"},{"key":"2026021807101138000_16.2.e099326.37","doi-asserted-by":"publisher","DOI":"10.2307\/2533558"},{"key":"2026021807101138000_16.2.e099326.38","doi-asserted-by":"publisher","DOI":"10.2307\/2951620"},{"key":"2026021807101138000_16.2.e099326.39","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.20552"},{"key":"2026021807101138000_16.2.e099326.40","doi-asserted-by":"crossref","first-page":"111538","DOI":"10.1016\/j.jclinepi.2024.111538","article-title":"Machine learning approaches to evaluate heterogeneous treatment effects in randomized controlled trials: a scoping review","volume":"176","author":"Inoue","year":"2024","journal-title":"J Clin Epidemiol"},{"key":"2026021807101138000_16.2.e099326.41","doi-asserted-by":"crossref","first-page":"4388","DOI":"10.1002\/sim.10167","article-title":"Modern approaches for evaluating treatment effect heterogeneity from clinical trials and observational data","volume":"43","author":"Lipkovich","year":"2024","journal-title":"Stat Med"},{"key":"2026021807101138000_16.2.e099326.42","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2023-078276","article-title":"Developing clinical prediction models: a step-by-step guide","volume":"386","author":"Efthimiou","year":"2024","journal-title":"BMJ"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-099326","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T15:16:46Z","timestamp":1772810206000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-099326"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":41,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,2,18]]},"published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1136\/bmjopen-2025-099326"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-099326","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2]]}}}