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Alzheimer's & Dementia ; 17(S10):e055294, 2021.
Article in English | Wiley | ID: covidwho-1589227

ABSTRACT

Background The coronavirus disease-19 (COVID-19) pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions. Method World-Wide FINGERS is an international network of clinical trials to assess the impact of multidomain lifestyle intervention on cognitive decline in at-risk adults. Individual trials are tailoring successful approaches from the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) to local cultures and environments. The network convened forums for researchers to discuss statistical design and analysis issues they faced during the pandemic. We will provide an updated report on experiences of trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues. We provide recommendations for future trials to consider as they develop and launch behavioral intervention trials. Result The pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessments protocols. The necessity of these changes add emphasis to the importance, in study design and analysis, of intention to treat approaches, flexibility, within site stratification, interim power projections, and sensitivity analyses. Conclusion Robust approaches to study design and analysis are critical to negotiate issues related to the intervention. The World Wide Network of similarly oriented clinical trials will allow us to evaluate the effectiveness of responses to the pandemic across cultures, local environments, and phases of the pandemic.

2.
Innovation in Aging ; 5(Supplement_1):68-68, 2021.
Article in English | PMC | ID: covidwho-1584833

ABSTRACT

The COVID-19 pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions. World-Wide FINGERS international network convened a forum for researchers to discuss statistical design and analysis issues they faced during the pandemic. We report experiences of three trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues. We provide recommendations for future trials to consider as they develop and launch behavioral intervention trials. The pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessments protocols. The necessity of these changes add emphasis to the importance, in study design and analysis, of intention to treat approaches, flexibility, within site stratification, interim power projections, and sensitivity analyses. Robust approaches to study design and analysis are critical to negotiate issues related to the intervention.

3.
Eur Psychiatry ; 64(1): e20, 2021 03 09.
Article in English | MEDLINE | ID: covidwho-1123674

ABSTRACT

BACKGROUND: Public health measures to curb SARS-CoV-2 transmission rates may have negative psychosocial consequences in youth. Digital interventions may help to mitigate these effects. We investigated the associations between social isolation, COVID-19-related cognitive preoccupation, worries, and anxiety, objective social risk indicators, and psychological distress, as well as use of, and attitude toward, mobile health (mHealth) interventions in youth. METHODS: Data were collected as part of the "Mental Health And Innovation During COVID-19 Survey"-a cross-sectional panel study including a representative sample of individuals aged 16-25 years (N = 666; Mage = 21.3; assessment period: May 5, 2020 to May 16, 2020). RESULTS: Overall, 38% of youth met criteria for moderate or severe psychological distress. Social isolation worries and anxiety, and objective risk indicators were associated with psychological distress, with evidence of dose-response relationships for some of these associations. For instance, psychological distress was progressively more likely to occur as levels of social isolation increased (reporting "never" as reference group: "occasionally": adjusted odds ratio [aOR] 9.1, 95% confidence interval [CI] 4.3-19.1, p < 0.001; "often": aOR 22.2, CI 9.8-50.2, p < 0.001; "very often": aOR 42.3, CI 14.1-126.8, p < 0.001). There was evidence that psychological distress, worries, and anxiety were associated with a positive attitude toward using mHealth interventions, whereas psychological distress, worries, and anxiety were associated with actual use. CONCLUSIONS: Public health measures during pandemics may be associated with poor mental health outcomes in youth. Evidence-based digital interventions may help mitigate the negative psychosocial impact without risk of viral infection given there is an objective need and subjective demand.


Subject(s)
COVID-19 , Internet-Based Intervention/statistics & numerical data , Mental Health , Quarantine , Social Isolation/psychology , Stress, Psychological , Anxiety/prevention & control , Anxiety/psychology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/psychology , Cross-Sectional Studies , Female , Germany/epidemiology , Humans , Male , Quarantine/methods , Quarantine/psychology , SARS-CoV-2 , Stress, Psychological/etiology , Stress, Psychological/prevention & control , Telemedicine/methods , Young Adult
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