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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Published by Elsevier Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8511868/
https://www.ncbi.nlm.nih.gov/pubmed/34653648
http://dx.doi.org/10.1016/j.cct.2021.106596
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author 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
author_facet 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
author_sort Kishimoto, Taishiro
collection PubMed
description 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).
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spelling pubmed-85118682021-10-13 Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology 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 Contemp Clin Trials Full Length Article 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). Published by Elsevier Inc. 2021-12 2021-10-13 /pmc/articles/PMC8511868/ /pubmed/34653648 http://dx.doi.org/10.1016/j.cct.2021.106596 Text en © 2021 Published by Elsevier Inc. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Full Length Article
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
Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
title Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
title_full Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
title_fullStr Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
title_full_unstemmed Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
title_short Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
title_sort japanese project for telepsychiatry evaluation during covid-19: treatment comparison trial (j-protect): rationale, design, and methodology
topic Full Length Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8511868/
https://www.ncbi.nlm.nih.gov/pubmed/34653648
http://dx.doi.org/10.1016/j.cct.2021.106596
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