TY - JOUR
T1 - Japanese project for telepsychiatry evaluation during COVID-19
T2 - Treatment comparison trial (J-PROTECT): Rationale, design, and methodology
AU - On Behalf of the J-PROTECT Collaborators
AU - Kishimoto, Taishiro
AU - Kinoshita, Shotaro
AU - Bun, Shogyoku
AU - Sato, Yasunori
AU - Kitazawa, Momoko
AU - Kikuchi, Toshiaki
AU - Sado, Mitsuhiro
AU - Takamiya, Akihiro
AU - Mimura, Masaru
AU - Nakamae, Takashi
AU - Abe, Yoshinari
AU - Kanazawa, Tetsufumi
AU - Kawabata, Yasuo
AU - Tomita, Hiroaki
AU - Abe, Koichi
AU - Hishimoto, Akitoyo
AU - Asami, Takeshi
AU - Suda, Akira
AU - Watanabe, Yoshinori
AU - Amagai, Toru
AU - Sakuma, Kei
AU - Kida, Hisashi
AU - Funayama, Michitaka
AU - Kimura, Hiroshi
AU - Sato, Aiko
AU - Fujiwara, Shuichiro
AU - Nagao, Kiichiro
AU - Sugiyama, Naoya
AU - Takamiya, Maki
AU - Kodama, Hideyuki
AU - Azekawa, Takaharu
N1 - Funding Information:
This research is supported by the Japan Agency for Medical Research and Development (AMED) under Grant Number JP21dk0307098 . The funding source did not participate in the design of this study and will not have any hand in the study's execution, analyses, or submission of results.
Publisher Copyright:
© 2021
PY - 2021/12
Y1 - 2021/12
N2 - 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).
AB - 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).
KW - Anxiety disorder
KW - Depression
KW - Master protocol
KW - Obsessive-compulsive disorder
KW - Telepsychiatry
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U2 - 10.1016/j.cct.2021.106596
DO - 10.1016/j.cct.2021.106596
M3 - Article
C2 - 34653648
AN - SCOPUS:85117788515
VL - 111
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 106596
ER -