1. Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial (J-PROTECT): Rationale, design, and methodology
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Kei Sakuma, Momoko Kitazawa, Yasunori Sato, Naoya Sugiyama, Yoshinori Watanabe, Yoshinari Abe, Masaru Mimura, Mitsuhiro Sado, Aiko Sato, Yasuo Kawabata, Kiichiro Nagao, Shotaro Kinoshita, Shogyoku Bun, Hiroshi Kimura, Hisashi Kida, Akitoyo Hishimoto, Taishiro Kishimoto, Hideyuki Kodama, Takashi Nakamae, Maki Takamiya, Hiroaki Tomita, Takaharu Azekawa, Takeshi Asami, Tetsufumi Kanazawa, Michitaka Funayama, Koichi Abe, Toshiaki Kikuchi, Toru Amagai, Akihiro Takamiya, Shuichiro Fujiwara, and Akira Suda
- Subjects
YBOCS, Yale-Brown Obsessive Compulsive Scale ,Research & Experimental Medicine ,THERAPY ,WAI, Working Alliance Inventory ,Japan ,QUALITY-OF-LIFE ,Obsessive-compulsive disorder ,ANXIETY ,EQ-5D, EuroQol 5 Dimension ,Pharmacology (medical) ,Pharmacology & Pharmacy ,CSQ, Client Satisfaction Questionnaire ,SCALE ,Depression (differential diagnoses) ,SF-36, Medical Outcomes Study 36-Item Short-Form Health Survey ,Psychiatry ,jRCT, Japan Registry of Clinical Trials ,Depression ,General Medicine ,SF-36 MCS, Medical Outcomes Study 36-Item Short-Form Health Survey Mental Component Summary ,ePRO, electronic Patient-Reported Outcome ,Telemedicine ,Medicine, Research & Experimental ,Anxiety disorder ,DSM-5, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ,Cohort ,Anxiety ,medicine.symptom ,Life Sciences & Biomedicine ,MENTAL-HEALTH ,FTF, face-to-face treatment ,EDC, Electronic Data Capture ,medicine.medical_specialty ,COVID-19, the 2019 novel coronavirus disease ,Full Length Article ,Master protocol ,medicine ,Humans ,QOL, Quality Of Life ,PRECIS2, Pragmatic-Explanatory Continuum Indicator Summary-2 ,COLLABORATIVE CARE ,HAMA, Hamilton Anxiety Rating Scale ,MMRM, Mixed-effects Model for Repeated Measurements ,Pandemics ,Telepsychiatry ,Science & Technology ,SARS-CoV-2 ,business.industry ,COVID-19 ,HAMD, Hamilton Depression Rating Scale ,J-PROTECT, Japanese Project for Telepsychiatry Evaluation during COVID-19: Treatment Comparison Trial ,medicine.disease ,Mental health ,Clinical trial ,OCD, Obsessive–Compulsive Disorder ,business - 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). ispartof: CONTEMPORARY CLINICAL TRIALS vol:111 ispartof: location:United States status: published
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- 2021
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