Contemporary clinical trials · 2021
Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kishimoto Taishiro, Kinoshita Shotaro, Bun Shogyoku, Sato Yasunori, Kitazawa Momoko, Kikuchi Toshiaki, Sado Mitsuhiro, Takamiya Akihiro, Mimura Masaru, Nakamae Takashi, Abe Yoshinari, Kanazawa Tetsufumi, Kawabata Yasuo, Tomita Hiroaki, Abe Koichi, Hishimoto Akitoyo, Asami Takeshi, Suda Akira, Watanabe Yoshinori, Amagai Toru, Sakuma Kei, Kida Hisashi, Funayama Michitaka, Kimura Hiroshi, Sato Aiko, Fujiwara Shuichiro, Nagao Kiichiro, Sugiyama Naoya, Takamiya Maki, Kodama Hideyuki, Azekawa Takaharu, J-PROTECT Collaborators
Аннотация
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).
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).