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

IntroductionThe 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. MethodsThe 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 visits to be conducted using telemedicine, with at least one face-to-face treatment [FTF] every six months) or an "FTF group" (all visits 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. DiscussionThis 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 RegistrationjRCT1030210037, Japan Registry of Clinical Trials (jRCT)

PTSD symptoms related to COVID-19 as a high risk factor for suicide - Key to prevention

BackgroundRising rates of suicide, the most dreadful consequence of mental health effects elicited by the coronavirus pandemic (COVID-19) are cause for grave concern. However, the exact association between mental health problems and suicide remains largely unknown in relation to COVID-19. MethodsTo determine the impact of COVID-19 on suicide trajectory, we used an interrupted time-series design to analyze monthly suicides rates extracted from Japans national database. We next used mixed-effects regression models to investigate the relationship between the nationwide suicide increase in August 2020 and psychiatric states of 4,348 individuals from an online survey performed immediately before (December 2019) and during (August 2020) the pandemic. Psychiatric states included depression, anxiety, and COVID-19-related PTSD, a form of severe event-related stress. FindingsIn Japan, suicides had gradually decreased before COVID-19 ({beta} = -0{middle dot}7x10-3, t57 = -14{middle dot}2, p = 8{middle dot}6x10-46), but increased drastically after a state of emergency was declared in April 2020 ({beta} = 0{middle dot}9x10-2, t57 = 17{middle dot}3, p = 2{middle dot}3x10-67). We found that PTSD symptoms reliably predict COVID-19s impact on suicide rates ({beta} = 6{middle dot}3x10-4, t3936 = 5{middle dot}96, p = 2{middle dot}7x10-9). In contrast, depression scores are a reliable indicator of stress vulnerability (i.e. future suicide increases, {beta} = 0{middle dot}001, t3936 = 6{middle dot}6, p = 4{middle dot}5x10-11). Simulations revealed that a one-point reduction in PTSD score could decrease suicides by up to 3{middle dot}1 per ten million people per month in Japan. InterpretationPTSD symptoms may help to identify high-risk groups so as to increase efficacy of prevention policies. FundingKDDI collaborative research contract, the Innovative Science and Technology Initiative for Security (JPJ004596), ATLA and AMED (JP20dm0307008). Research in contextO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed on December 2, 2020, for "COVID" and "suicid*" in the titles or abstracts of published articles and obtained 269 hits. No language restrictions were applied to the search. Nearly all previous articles on suicide and COVID-19 have reported simulation studies of suicide counts and rates in case studies, editorials, letters, and commentaries. To date, no study has analyzed the association between psychiatric states and suicide increases in the context of the COVID-19 pandemic. Added value of this studyTo the best of our knowledge, this is the first study reporting a concrete approach to predict suicide rate increases from psychiatric states during the COVID-19 pandemic. Our findings indicate that PTSD symptoms are a reliable surrogate endpoint of pandemic-related suicide increase. Implications of all available evidenceThis work provides a new perspective on preparing guidelines for suicide prevention. Efforts should focus on reducing PTSD severity for single individuals and populations to reduce the overall suicide risk.