| Title {1} | Translated and culturally adapted internet-delivered cognitive therapy for social anxiety disorder in Japanese clinical settings: study protocol for a randomised controlled trial |
| Trial registration {2a and 2b}. | International Standard Randomized Controlled Trials (ISRCTN), ISRCTN82859645, registered on January 19, 2024. UMIN Clinical Trials Registry (UMIN-CTR), UMIN000052702, registered on November 6 2023. |
| Protocol version {3} | Protocol version 1.0, 2023-October-18 |
| Funding {4} | This trial is supported by the Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (JSPS) (20H01769 to NY), the Daiwa Anglo-Japanese Foundation (13,068 and 13,890 to GRT), the Wellcome Trust [200796 to DMC], and the Oxford Health NIHR Biomedical Research Centre. |
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Author details {5a} * Correspondence (NY: naokiy@med.miyazaki-u.ac.jp; GRT:graham.thew@psy.ox.ac.uk) |
Naoki Yoshinaga1*, Graham R. Thew2,3*, Yuta Hayashi4, Hiroki Tanoue1, Michikazu Nakai5,6, David M. Clark2 1 School of Nursing, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki City, Miyazaki 889–1692, Japan 2 Department of Experimental Psychology, University of Oxford, The Old Rectory, Paradise Square, Oxford OX1 1TW, UK 3 Oxford Health NHS Foundation Trust, Oxford, UK 4 Department of Nursing, Graduate School of Health Sciences, Kobe University, 7–10-2 Tomogaoka, Suma-ku, Kobe, Hyogo 654–0142 Japan 5 Division of Data Management, Department of Social Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki City, Miyazaki 889–1692, Japan 6 Clinical Research Support Center, University of Miyazaki Hospital, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki City, Miyazaki 889–1692, Japan |
| Name and contact information for the trial sponsor {5b} | This investigator-initiated trial is sponsored by the Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki City, Miyazaki 889–1692, Japan. |
| Role of sponsor {5c} | The funding sources had no role in the design of this trial and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. |