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Kishimoto T, Kinoshita S, Bun S, et al. Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology. Contemp Clin Trials. 2021;111:106596doi: 10.1016/j.cct.2021.106596.
Kishimoto, T., Kinoshita, S., Bun, S., Sato, Y., Kitazawa, M., Kikuchi, T., Sado, M., Takamiya, A., Mimura, M., Nakamae, T., Abe, Y., Kanazawa, T., Kawabata, Y., Tomita, H., Abe, K., Hishimoto, A., Asami, T., Suda, A., Watanabe, Y., Amagai, T., Sakuma, K., Kida, H., Funayama, M., Kimura, H., Sato, A., Fujiwara, S., Nagao, K., Sugiyama, N., Takamiya, M., Kodama, H., Azekawa, T. (2021). Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology. Contemporary clinical trials, 111106596. https://doi.org/10.1016/j.cct.2021.106596
Kishimoto, Taishiro, et al. "Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology." Contemporary clinical trials vol. 111 (2021): 106596. doi: https://doi.org/10.1016/j.cct.2021.106596
Kishimoto T, Kinoshita S, Bun S, Sato Y, Kitazawa M, Kikuchi T, Sado M, Takamiya A, Mimura M, Nakamae T, Abe Y, Kanazawa T, Kawabata Y, Tomita H, Abe K, Hishimoto A, Asami T, Suda A, Watanabe Y, Amagai T, Sakuma K, Kida H, Funayama M, Kimura H, Sato A, Fujiwara S, Nagao K, Sugiyama N, Takamiya M, Kodama H, Azekawa T. Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology. Contemp Clin Trials. 2021 Dec;111:106596. doi: 10.1016/j.cct.2021.106596. Epub 2021 Oct 13. PMID: 34653648; PMCID: PMC8511868.
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Contemp Clin Trials. 2021 Dec;111:106596. doi: 10.1016/j.cct.2021.106596. Epub 2021 Oct 13.

Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology.

Contemporary clinical trials

Taishiro Kishimoto, Shotaro Kinoshita, Shogyoku Bun, Yasunori Sato, Momoko Kitazawa, Toshiaki Kikuchi, Mitsuhiro Sado, Akihiro Takamiya, Masaru Mimura, Takashi Nakamae, Yoshinari Abe, Tetsufumi Kanazawa, Yasuo Kawabata, Hiroaki Tomita, Koichi Abe, Akitoyo Hishimoto, Takeshi Asami, Akira Suda, Yoshinori Watanabe, Toru Amagai, Kei Sakuma, Hisashi Kida, Michitaka Funayama, Hiroshi Kimura, Aiko Sato, Shuichiro Fujiwara, Kiichiro Nagao, Naoya Sugiyama, Maki Takamiya, Hideyuki Kodama, Takaharu Azekawa,

Affiliations

  1. Hills Joint Research Laboratory for Future Preventive Medicine and Wellness, Keio University School of Medicine, #7F Roppongi Hills, North Tower 6-2-31 Roppongi, Minato-ku, Tokyo 106-0032, Japan. Electronic address: [email protected].
  2. Hills Joint Research Laboratory for Future Preventive Medicine and Wellness, Keio University School of Medicine, #7F Roppongi Hills, North Tower 6-2-31 Roppongi, Minato-ku, Tokyo 106-0032, Japan; Graduate School of Medicine, International University of Health and Welfare, 4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan.
  3. Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan; Sato Hospital, 948-1 Kunugizuka, Nanyo, Yamagata 999-2221, Japan.
  4. Department of Preventive Medicine and Public Health, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan.
  5. Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
  6. Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo, Kyoto, Kyoto 602-8566, Japan.
  7. Department of Neuropsychiatry, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.
  8. Department of Psychiatry, Tohoku University Hospital, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan; Department of Psychiatry, Tohoku University Graduate School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan.
  9. Department of Psychiatry, Tohoku University Hospital, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan.
  10. Department of Psychiatry, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.
  11. Himorogi Psychiatric Institute, Ichigaya-Asukara Bldg. 1F2F, 2-31-3 Ichigayatamachi, Shinjuku, Tokyo 162-0843, Japan.
  12. Amagai Mental Clinic, Kitami Bldg. 3F, 1-4-20 Kamiooka-nishi, Konan, Yokohama, Kanagawa 233-0002, Japan.
  13. Asaka Hospital, 45 Kyotan, Sasagawa, Asakamachi, Koriyama, Fukushima 963-0198, Japan.
  14. Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan; Asaka Hospital, 45 Kyotan, Sasagawa, Asakamachi, Koriyama, Fukushima 963-0198, Japan.
  15. Department of Neuropsychiatry, Ashikaga Red Cross Hospital, 284-1 Yobe, Ashikaga, Tochigi 326-0843, Japan.
  16. Department of Psychiatry, Gakuji-kai Kimura Hospital, 6-19, Higashi Honcho, Chuo-ku, Chiba, Chiba 260-0004, Japan; Department of Psychiatry, School of Medicine, International University of Health and Welfare, 4-3, Kozunomori, Narita, Chiba 286-8686, Japan.
  17. Department of Psychiatry, School of Medicine, International University of Health and Welfare, 4-3, Kozunomori, Narita, Chiba 286-8686, Japan.
  18. Kanazawabunko Yell Clinic, Kanazawa Bunko Park Homes 102, Kamariyahigashi, Kanazawa, Yokohama, Kanagawa 236-0042, Japan.
  19. Neyagawa Sanatoriumu, 2370-6 Neyagawakoen, Neyagawa, Osaka, Osaka 572-0854, Japan.
  20. Numazu Chuo Hospital, 24-1 Nakase-cho, Numazu, Shizuoka 410-8575, Japan.
  21. Takamiya Hospital, 1931 Omachikou, Yoshimura, Miyazaki, Miyazaki 880-0841, Japan.
  22. Shioiri Mental Clinic, 2-7-1 Shioiri, Yokosuka, Kanagawa, 238-0042, Japan.

PMID: 34653648 PMCID: PMC8511868 DOI: 10.1016/j.cct.2021.106596

Abstract

INTRODUCTION: The COVID-19 pandemic has had a profound impact on the mental health of people around the world. Anxiety related to infection, stress and stigma caused by the forced changes in daily life have reportedly increased the incidence and symptoms of depression, anxiety disorder and obsessive-compulsive disorder. Under such circumstances, telepsychiatry is gaining importance and attracting a great deal of attention. However, few large pragmatic clinical trials on the use of telepsychiatry targeting multiple psychiatric disorders have been conducted to date.

METHODS: The targeted study cohort will consist of adults (>18 years) who meet the DSM-5 diagnostic criteria for either (1) depressive disorders, (2) anxiety disorders, or (3) obsessive-compulsive and related disorders. Patients will be assigned in a 1:1 ratio to either a "telepsychiatry group" (at least 50% of treatments to be conducted using telemedicine, with at least one face-to-face treatment [FTF] within six months) or an "FTF group" (all treatments to be conducted FTF, with no telemedicine). Both groups will receive the usual treatment covered by public medical insurance. The study will utilize a master protocol design in that there will be primary and secondary outcomes for the entire group regardless of diagnosis, as well as the outcomes for each individual disorder group.

DISCUSSION: This study will be a non-inferiority trial to test that the treatment effect of telepsychiatry is not inferior to that of FTF alone. This study will provide useful insights into the effect of the COVID-19 pandemic on the practice of psychiatry.

TRIAL REGISTRATION: jRCT1030210037, Japan Registry of Clinical Trials (jRCT).

Copyright © 2021. Published by Elsevier Inc.

Keywords: Anxiety disorder; Depression; Master protocol; Obsessive-compulsive disorder; Telepsychiatry

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