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      A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial


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          “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions.


          Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial.


          We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization.


          The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments.


          This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people.

          Trial Registration

          ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486

          International Registered Report Identifier (IRRID)


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          Most cited references33

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          SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

          High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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            Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) — United States, February 12–March 16, 2020

            On March 18, 2020, this report was posted online as an MMWR Early Release. Globally, approximately 170,000 confirmed cases of coronavirus disease 2019 (COVID-19) caused by the 2019 novel coronavirus (SARS-CoV-2) have been reported, including an estimated 7,000 deaths in approximately 150 countries ( 1 ). On March 11, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic ( 2 ). Data from China have indicated that older adults, particularly those with serious underlying health conditions, are at higher risk for severe COVID-19–associated illness and death than are younger persons ( 3 ). Although the majority of reported COVID-19 cases in China were mild (81%), approximately 80% of deaths occurred among adults aged ≥60 years; only one (0.1%) death occurred in a person aged ≤19 years ( 3 ). In this report, COVID-19 cases in the United States that occurred during February 12–March 16, 2020 and severity of disease (hospitalization, admission to intensive care unit [ICU], and death) were analyzed by age group. As of March 16, a total of 4,226 COVID-19 cases in the United States had been reported to CDC, with multiple cases reported among older adults living in long-term care facilities ( 4 ). Overall, 31% of cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths associated with COVID-19 were among adults aged ≥65 years with the highest percentage of severe outcomes among persons aged ≥85 years. In contrast, no ICU admissions or deaths were reported among persons aged ≤19 years. Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups. Data from cases reported from 49 states, the District of Columbia, and three U.S. territories ( 5 ) to CDC during February 12–March 16 were analyzed. Cases among persons repatriated to the United States from Wuhan, China and from Japan (including patients repatriated from cruise ships) were excluded. States and jurisdictions voluntarily reported data on laboratory-confirmed cases of COVID-19 using previously developed data collection forms ( 6 ). The cases described in this report include both COVID-19 cases confirmed by state or local public health laboratories as well as those with a positive test at the state or local public health laboratories and confirmation at CDC. No data on serious underlying health conditions were available. Data on these cases are preliminary and are missing for some key characteristics of interest, including hospitalization status (1,514), ICU admission (2,253), death (2,001), and age (386). Because of these missing data, the percentages of hospitalizations, ICU admissions, and deaths (case-fatality percentages) were estimated as a range. The lower bound of these percentages was estimated by using all cases within each age group as denominators. The corresponding upper bound of these percentages was estimated by using only cases with known information on each outcome as denominators. As of March 16, a total of 4,226 COVID-19 cases had been reported in the United States, with reports increasing to 500 or more cases per day beginning March 14 (Figure 1). Among 2,449 patients with known age, 6% were aged ≥85, 25% were aged 65–84 years, 18% each were aged 55–64 years and 45–54 years, and 29% were aged 20–44 years (Figure 2). Only 5% of cases occurred in persons aged 0–19 years. FIGURE 1 Number of new coronavirus disease 2019 (COVID-19) cases reported daily*,† (N = 4,226) — United States, February 12–March 16, 2020 * Includes both COVID-19 cases confirmed by state or local public health laboratories, as well as those testing positive at the state or local public health laboratories and confirmed at CDC. † Cases identified before February 28 were aggregated and reported during March 1–3. The figure is a histogram, an epidemiologic curve showing 4,226 coronavirus disease 2019 (COVID-19) cases, by date of case report, in the United States during February 12–March 16, 2020. Figure 2 Coronavirus disease 2019 (COVID-19) hospitalizations,* intensive care unit (ICU) admissions, † and deaths, § by age group — United States, February 12– March 16, 2020 * Hospitalization status missing or unknown for 1,514 cases. † ICU status missing or unknown for 2,253 cases. § Illness outcome or death missing or unknown for 2,001 cases. The figure is a bar chart showing the number of coronavirus disease 2019 (COVID-19) hospitalizations, intensive care unit admissions, and deaths, by age group, in the United States during February 12– March 16, 2020. Among 508 (12%) patients known to have been hospitalized, 9% were aged ≥85 years, 36% were aged 65–84 years, 17% were aged 55–64 years, 18% were 45–54 years, and 20% were aged 20–44 years. Less than 1% of hospitalizations were among persons aged ≤19 years (Figure 2). The percentage of persons hospitalized increased with age, from 2%–3% among persons aged ≤19 years, to ≥31% among adults aged ≥85 years. (Table). TABLE Hospitalization, intensive care unit (ICU) admission, and case–fatality percentages for reported COVID–19 cases, by age group —United States, February 12–March 16, 2020 Age group (yrs) (no. of cases) %* Hospitalization ICU admission Case-fatality 0–19 (123) 1.6–2.5 0 0 20–44 (705) 14.3–20.8 2.0–4.2 0.1–0.2 45–54 (429) 21.2–28.3 5.4–10.4 0.5–0.8 55–64 (429) 20.5–30.1 4.7–11.2 1.4–2.6 65–74 (409) 28.6–43.5 8.1–18.8 2.7–4.9 75–84 (210) 30.5–58.7 10.5–31.0 4.3–10.5 ≥85 (144) 31.3–70.3 6.3–29.0 10.4–27.3 Total (2,449) 20.7–31.4 4.9–11.5 1.8–3.4 * Lower bound of range = number of persons hospitalized, admitted to ICU, or who died among total in age group; upper bound of range = number of persons hospitalized, admitted to ICU, or who died among total in age group with known hospitalization status, ICU admission status, or death. Among 121 patients known to have been admitted to an ICU, 7% of cases were reported among adults ≥85 years, 46% among adults aged 65–84 years, 36% among adults aged 45–64 years, and 12% among adults aged 20–44 years (Figure 2). No ICU admissions were reported among persons aged ≤19 years. Percentages of ICU admissions were lowest among adults aged 20–44 years (2%–4%) and highest among adults aged 75–84 years (11%–31%) (Table). Among 44 cases with known outcome, 15 (34%) deaths were reported among adults aged ≥85 years, 20 (46%) among adults aged 65–84 years, and nine (20%) among adults aged 20–64 years. Case-fatality percentages increased with increasing age, from no deaths reported among persons aged ≤19 years to highest percentages (10%–27%) among adults aged ≥85 years (Table) (Figure 2). Discussion Since February 12, 4,226 COVID-19 cases were reported in the United States; 31% of cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred among adults aged ≥65 years with the highest percentage of severe outcomes among persons aged ≥85 years. These findings are similar to data from China, which indicated >80% of deaths occurred among persons aged ≥60 years ( 3 ). These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19. In contrast, persons aged ≤19 years appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group. Given the spread of COVID-19 in many U.S. communities, CDC continues to update current recommendations and develop new resources and guidance, including for adults aged ≥65 years as well as those involved in their care ( 7 , 8 ). Approximately 49 million U.S. persons are aged ≥65 years ( 9 ), and many of these adults, who are at risk for severe COVID-19–associated illness, might depend on services and support to maintain their health and independence. To prepare for potential COVID-19 illness among persons at high risk, family members and caregivers of older adults should know what medications they are taking and ensure that food and required medical supplies are available. Long-term care facilities should be particularly vigilant to prevent the introduction and spread of COVID-19 ( 10 ). In addition, clinicians who care for adults should be aware that COVID-19 can result in severe disease among persons of all ages. Persons with suspected or confirmed COVID-19 should monitor their symptoms and call their provider for guidance if symptoms worsen or seek emergency care for persistent severe symptoms. Additional guidance is available for health care providers on CDC’s website (https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html). This report describes the current epidemiology of COVID-19 in the United States, using preliminary data. The findings in this report are subject to at least five limitations. First, data were missing for key variables of interest. Data on age and outcomes, including hospitalization, ICU admission, and death, were missing for 9%–53% of cases, which likely resulted in an underestimation of these outcomes. Second, further time for follow-up is needed to ascertain outcomes among active cases. Third, the initial approach to testing was to identify patients among those with travel histories or persons with more severe disease, and these data might overestimate the prevalence of severe disease. Fourth, data on other risk factors, including serious underlying health conditions that could increase risk for complications and severe illness, were unavailable at the time of this analysis. Finally, limited testing to date underscores the importance of ongoing surveillance of COVID-19 cases. Additional investigation will increase the understanding about persons who are at risk for severe illness and death from COVID-19 and inform clinical guidance and community-based mitigation measures.* The risk for serious disease and death in COVID-19 cases among persons in the United States increases with age. Social distancing is recommended for all ages to slow the spread of the virus, protect the health care system, and help protect vulnerable older adults. Further, older adults should maintain adequate supplies of nonperishable foods and at least a 30-day supply of necessary medications, take precautions to keep space between themselves and others, stay away from those who are sick, avoid crowds as much as possible, avoid cruise travel and nonessential air travel, and stay home as much as possible to further reduce the risk of being exposed ( 7 ). Persons of all ages and communities can take actions to help slow the spread of COVID-19 and protect older adults. † Summary What is already known about this topic? Early data from China suggest that a majority of coronavirus disease 2019 (COVID-19) deaths have occurred among adults aged ≥60 years and among persons with serious underlying health conditions. What is added by this report? This first preliminary description of outcomes among patients with COVID-19 in the United States indicates that fatality was highest in persons aged ≥85, ranging from 10% to 27%, followed by 3% to 11% among persons aged 65–84 years, 1% to 3% among persons aged 55-64 years, <1% among persons aged 20–54 years, and no fatalities among persons aged ≤19 years. What are the implications for public health practice? COVID-19 can result in severe disease, including hospitalization, admission to an intensive care unit, and death, especially among older adults. Everyone can take actions, such as social distancing, to help slow the spread of COVID-19 and protect older adults from severe illness.
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              The Mental Health Consequences of COVID-19 and Physical Distancing: The Need for Prevention and Early Intervention


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                October 2021
                6 October 2021
                6 October 2021
                : 10
                : 10
                : e30339
                [1 ] Sangath New Delhi India
                [2 ] School of Psychology University of Sussex Brighton United Kingdom
                [3 ] Medical Research Council Tropical Epidemiology Group, Faculty of Epidemiology and Population Health London School of Hygiene & Tropical Medicine London United Kingdom
                [4 ] Department of Psychiatry University of Oxford Oxford United Kingdom
                [5 ] Department of Clinical Psychology Vrije Universiteit Amsterdam Netherlands
                [6 ] Department of Global Health and Social Medicine Harvard Medical School Boston, MA United States
                Author notes
                Corresponding Author: Pattie P Gonsalves pattie.gonsalves@ 123456sangath.in
                Author information
                ©Pattie P Gonsalves, Rhea Sharma, Eleanor Hodgson, Bhargav Bhat, Abhijeet Jambhale, Helen A Weiss, Christopher G Fairburn, Kate Cavanagh, Pim Cuijpers, Daniel Michelson, Vikram Patel. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.10.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 13 May 2021
                : 5 August 2021
                : 25 August 2021
                : 25 August 2021

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