. 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

Taishiro Kishimoto¹, Shotaro Kinoshita², Shogyoku Bun³, Yasunori Sato⁴, Momoko Kitazawa⁵, Toshiaki Kikuchi⁵, Mitsuhiro Sado⁵, Akihiro Takamiya⁵, Masaru Mimura⁵, Takashi Nakamae⁶, Yoshinari Abe⁶, Tetsufumi Kanazawa⁷, Yasuo Kawabata⁷, Hiroaki Tomita⁸, Koichi Abe⁹, Akitoyo Hishimoto¹⁰, Takeshi Asami¹⁰, Akira Suda¹⁰, Yoshinori Watanabe¹¹, Toru Amagai¹², Kei Sakuma¹³, Hisashi Kida¹⁴, Michitaka Funayama¹⁵, Hiroshi Kimura¹⁶, Aiko Sato¹⁷, Shuichiro Fujiwara¹⁸, Kiichiro Nagao¹⁹, Naoya Sugiyama²⁰, Maki Takamiya²¹, Hideyuki Kodama²¹, Takaharu Azekawa²²; J-PROTECT Collaborators

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: taishiro-k@mti.biglobe.ne.jp.
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

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

Taishiro Kishimoto et al. Contemp Clin Trials. 2021 Dec.

. 2021 Dec:111:106596.

doi: 10.1016/j.cct.2021.106596. Epub 2021 Oct 13.

Authors

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: taishiro-k@mti.biglobe.ne.jp.
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).

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

PubMed Disclaimer

Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

T. Kishimoto: Research grant funding, Micin.

T. Nakamae: Provided with a telemedicine system, Medley.

Y. Abe: Provided with a telemedicine system, Medley.

Figures

**Fig. 1**
Pragmatism wheel according to PRECIS-2 tool.

See this image and copyright information in PMC

Cited by

Psychiatric treatment conducted via telemedicine versus in-person consultations in mood, anxiety and personality disorders: a protocol for a systematic review and meta-analysis.
Shaker AA, Austin SF, Sørensen JA, Storebø OJ, Simonsen E. Shaker AA, et al. BMJ Open. 2022 Sep 28;12(9):e060690. doi: 10.1136/bmjopen-2021-060690. BMJ Open. 2022. PMID: 36171023 Free PMC article.
A systematic review of studies on stress during the COVID-19 pandemic by visualizing their structure through COOC, VOS viewer, and Cite Space software.
Lu L, Liu G, Xu Y, Jiang J, Wei Z. Lu L, et al. Front Psychiatry. 2024 Jan 25;15:1297112. doi: 10.3389/fpsyt.2024.1297112. eCollection 2024. Front Psychiatry. 2024. PMID: 38333890 Free PMC article.

References

1. Xiong J., Lipsitz O., Nasri F., Lui L.M.W., Gill H., Phan L., Chen-Li D., Iacobucci M., Ho R., Majeed A., McIntyre R.S. Impact of COVID-19 pandemic on mental health in the general population: a systematic review. J. Affect. Disord. 2020 Dec 1;277:55–64. doi: 10.1016/j.jad.2020.08.001. - DOI - PMC - PubMed
1. Jelinek L., Moritz S., Miegel F., Voderholzer U. Obsessive-compulsive disorder during COVID-19: turning a problem into an opportunity? J. Anxiety Disord. 2021 Jan;77:102329. doi: 10.1016/j.janxdis.2020.102329. - DOI - PMC - PubMed
1. Taquet M., Luciano S., Geddes J.R., Harrison P.J. Bidirectional associations between COVID-19 and psychiatric disorder: retrospective cohort studies of 62 354 COVID-19 cases in the USA. Lancet Psychiatry. 2021 Feb;8(2):130–140. doi: 10.1016/S2215-0366(20)30462-4. - DOI - PMC - PubMed
1. World Health Organization The Impact of COVID-19 on Mental, Neurological and Substance Use Services: Results of a Rapid Assessment. https://apps.who.int/iris/rest/bitstreams/1310579/retrieve URL: (accessed: 2021/9/9)
1. Keshvardoost S., Bahaadinbeigy K., Fatehi F. Role of Telehealth in the management of COVID-19: lessons learned from previous SARS, MERS, and Ebola outbreaks. Telemed. J. E Health. 2020 Jul;26(7):850–852. doi: 10.1089/tmj.2020.0105. - DOI - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical