RinasciMENTE. An Internet-Based Self-Help Intervention to Cope With Psychological Distress Due to COVID-19: A Study Protocol for a Randomized Controlled Trial (preprint)

Background: This study aims to evaluate the feasibility and effectiveness of the RinasciMENTE program, an Internet-based self-help intervention based on Cognitive Behavioral Therapy (CBT) principles and techniques in supporting individuals experiencing psychological impairments during the COVID-19 pandemic. A randomized controlled trial (RCT) design with random allocation at the level of individual will be conducted to compare the impact of the RinasciMENTE program with a waiting list control in improving the psychological functioning of the general population during the COVID-19 pandemic. Methods: A minimum sample of 128 participants experiencing mild/subthreshold levels of psychological symptoms during the COVID-19 pandemic will be recruited. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 2 months, during which participants will receive 8 weekly CBT treatment modules. The impact of the RinasciMENTE program on selected primary and secondary psychological outcomes will be tested at the end of the intervention (2 months), 6- and 12-month follow-up. Discussion: We expect people to show an increased level of psychological functioning, and to acquire the skills and self-confidence necessary to deal with the psychological consequences of the COVID-19 outbreak and its related social isolation during and following the pandemic. Trial registration ClinicalTrials.gov NCT0497903 Registered on 28 May 2021.

COVID Feel Good – A Self-Help Virtual Therapeutic Experience for Overcoming the Psychological Distress of the COVID-19 Pandemic: Results from a European Multicentric Trial (preprint)

The primary aim of the present study was to investigate the efficacy of a self-help virtual therapeutic experience (COVID Feel Good) for reducing the psychological burden experienced during the COVID-19 lockdown across different countries. For this purpose, we focused on participants recruited from June 2020 to May 2021 in the context of a European multicenter project including four university/academic sites. Primary outcome measures were depression, anxiety and stress symptoms, perceived stress levels and hopelessness. Secondary outcomes were the experienced social connectedness and the level of fear experienced during the COVID-19 pandemic. To assess the efficacy of the intervention in a multicentric context, we evaluated the strength of evidence supporting the COVID Feel Good computing a single summary estimate of the effect across the different countries. Using separate linear mixed-effect models, the most consistent result across the different countries was an improvement of the perceived stress level after the participation in the COVID Feel Good intervention. By pooling the results of the models using a random-effect meta-analysis, we found that COVID Feel Good intervention was associated a decrease in the perceived general distress [mean standardized effect size for general distress in the treatment groups compared to the control conditions was 0.52 (p = 0.007, 95% CI: 0.14, 0.89] and with an increase the perceived social connection [mean standardized effect size for social connection using COVID Feel Good compared to the control conditions was -0.50 (p = < 0.001, 95% CI: -0.76, -0.25)]. Globally findings suggest the efficacy of the proposed protocol and contribute the growing literature supporting the use of digital psychological interventions to reduce the psychological stress among general population during the COVID-19 crisis.

A Free Weekly Self-Administered at-Home Virtual Reality based Protocol for Overcoming the Psychological Burden of Coronavirus: A Pragmatic Waitlist-Controlled Trial Conducted During COVID-19 lockdown in Italy with 2-week follow-up (preprint)

Background: The COVID-19 pandemic is generating extreme psychological stress associated with sadness, grief, irritability, and mood swings. Virtual reality (VR) is an immersive technology that may enhance individuals’ personal efficacy, emotional response, and wellbeing. Objective: We aimed to conduct a single-cohort, controlled trial with a 2:1 (waiting-list – VR protocol) allocation for a self-administered at-home weekly VR-based protocol for reducing the psychological burden experienced during the COVID-19 lockdown in Italy. Methods: A national convenience sample of individuals having experienced at least two months of strict social distancing measures (including the stay-at-home order) experienced the following weekly protocol (“COVID Feel Good”, available online here: www.covidfeelgood.com) consisting of two integrated parts: the first part consists of a 10-minute 360° VR video entitled “Secret Garden” and the second part includes a series of social exercises, with a specific goal for each day of the week. Half of the sample experienced the VR video on the smartphone only, while the other half experienced the VR video using an immersive headset. Primary outcome measures were depressive, anxiety and stress symptoms (measured using the DASS-21, the PSS and the BHS scales). Secondary outcomes were the experienced social connectedness and the level of fear experienced during the COVID-19 pandemic (measured using the SCS and FCOR scales). Analytic methods included different separate linear mixed-effects models. Results: The study sample was 40 adults [18 females; mean age 30.3± 12.00 (range: 21–65)]. Results indicated no significant changes (P=1.000) in study variables between the waiting period (i.e., data collected 7 days before the start of the treatment) and the baseline (i.e., data collected at the beginning of the intervention, T0). Participants exhibited improvement from baseline to postintervention for almost all primary variables (all Ps < 0.05), except for the perceived hopelessness (P=0.1098). Results for the secondary outcomes indicated an increase in social connectedness from T0 to T1 (P=0.0327), but not a significant reduction in the perceived fear of Coronavirus (P=0.4121). Results indicated that treatment positive effects were stable at the 2-weels of follow-up for all study variables, except for depressive symptoms. None of the models were significant on the factor “Immersion”, suggesting that there is no significant effect of the modality (immersive vs non immersive) on the results of the treatment. Conclusions: This pragmatic pilot trial tried to understand if and how a weekly VR self-help protocol can help individuals in overcoming the psychological burden associated with spread of the COVID-19 and the consequent health emergency. The results, even if preliminary, suggest the efficacy of the proposed protocol. Moreover, its current availability in 12 different languages - English, Spanish, French, Brazilian/Portuguese, German, Italian, Turkish Japanese, Korean, Farsi, Romanian and Catalan – make COVID Feel Good a free and effective choice for helping individuals worldwide to cope with the psychological distress related to the COVID-19 crisis.

Resilience contributes to low emotional impact of the COVID-19 outbreak among the general population in Italy (preprint)

BackgroundThe COVID-19 outbreak is severely affecting overall mental health with unknown psychological consequences. The Italian Government has implemented a massive lockdown to decrease the spread of the virus. Although a strong psychological impact is possible, few evidences are still available. Past studies have shown that resilience decreases the negative effects of stress promoting mental health. For these reasons, this study aimed to examine depression, anxiety, and stress among the Italian general population during the phase characterizing by lockdown, and to investigate the role of resilience as a potential predictor. MethodsA total sample of 6314 Italian people participated in this study. Participants were recruited between March 10 and May 4 2020 through an online survey, the majority of whom from Northern Italy. The Depression Anxiety Stress Scales-21 (DASS-21) (a measure of mental health status) and the Resilience Scale (RS) (a measure of resilience) were administered. Also, demographic data and lockdown related information were collected. DASS-21 cut-off scores were used to verify the mental status among the participants. Subsequently, a correlational analysis was carried out to examine relationships between DASS-21 and RS. Lastly, three hierarchical regression analyses were conducted using the three DASS-21 scales as dependent variables and the RS scales as independent variables controlling for age, gender, and education. ResultsThe prevalence of moderate to extremely severe symptoms among participants was 36.1% for depression, 28.7% for anxiety, and 35.6% for stress. Results of correlational analysis showed that resilience factors, such as meaningfulness, self-reliance, existential aloneness, and equanimity, are inversely associated with depression, anxiety, and stress. Results of regression analyses indicated that all the resilience factors were statistically significant in predicting anxiety, while meaningfulness, perseverance, existential aloneness, and equanimity predicted depression and stress. ConclusionsDuring the lockdown following the COVID-19 outbreak, about a third of respondents reported moderate to extremely severe depression, anxiety, and stress. The present study suggests that psychological resilience may independently contribute to low emotional distress and psychological ill-being. These findings can help explain the variability of individual responses during the COVID-19 outbreak. Psychological interventions to enhance resilience might provide useful approaches to overcome COVID-related emotional impact.

Poor quality of sleep and its consequences on mental health during COVID-19 lockdown in Italy (preprint)

BackgroundCoronavirus disease 2019 (COVID-19) seriously affected all Italy. The extreme virulence, the speed of propagation resulted in restrictions and home confinement. This change was immediately perceived by people who found themselves exposed to feelings of uncertainty, fear, anger, stress and a drastic change in the diurnal but above all nocturnal lifestyle. For these reasons, we aimed to study the quality of sleep and its connection to distress levels and evaluate how lifestyle changed in the Italian population during the lockdown.MethodsThrough an internet survey we recruited 6,519 adults during the whole COVID-19 lockdown (from 10thMarch – 1st phase - to 4th May – 2nd phase). We investigated the socio-demographic and COVID-19 related information and assessed sleep quality using the Medical Outcomes Study - sleep scale (MOS-SS) and mental health with the short form of Depression, Anxiety, and Stress Scales – 21 Items (DASS-21). Multiple logistic regression model was used to evaluate the multivariate association between the dependent variable (good sleeper vs. poor sleeper) and all the variables that were significant in the univariate analysis.Results3,562 (55.32%) participants reported poor sleep quality according to the MOS-Sleep Index II score. The multiple binary logistic regression results of poor sleepers reveal several risk factors during the outbreak restrictions: female gender, living in Central Italy, having someone close who died due to COVID-19, markedly changed sleep-wake rhythm characterized by earlier or postponed habitual bedtime, earlier habitual awakening time and reduced number of afternoon naps, extremely severe levels of stress, of anxiety, and of depression. ConclusionsThis is the first study designed to understand sleep quality and sleep habits during the whole lockdown in the Italian population that provides more than 6,000 participants in a survey developed specifically for the health emergency related to COVID-19. Our study found that more than half of the Italian population have had impaired sleep quality and sleep habits elevated psychological distress during the COVID-19 lockdown containment measures. A multidisciplinary action should be taken in order to plan appropriate responses to the current crisis caused by the COVID-19 health emergency.

COVID Feel Good – An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus (preprint)

Background: Living in the time of the COVID-19 means experiencing not only a global health emergency but also extreme psychological stress with potential emotional side effects such as sadness, grief, irritability and mood swings. Crucially, lockdown and confinement measures isolate people who become the first and the only ones in charge of their own mental health: people are left alone facing a novel and potentially lethal situation, and, at the same time, they need to develop adaptive strategies to face it, at home. In this view, easy-to-use, inexpensive, and scientifically validated self-help solutions aiming to reduce the psychological burden of coronavirus are extremely necessary. Aims: This pragmatic trial aims to provide the evidence that a weekly self-help virtual reality (VR) protocol can help overcome the psychological burden of the Coronavirus by relieving anxiety, improving well-being and reinforcing social connectedness. The protocol will be based on the “Secret Garden” 360 VR video online (www.covidfeelgood.com) which simulates a natural environment aiming to promote relaxation and self-reflexion. 360° or spherical videos allow the user to control the viewing direction. In this way, the user can explore the content from any angle like a panorama and experience presence and immersion. The “Secret Garden” video is combined with daily exercises that are designed to be experienced with another person (not necessarily physically together), to facilitate a process of critical examination and eventual revision of core assumptions and beliefs related to personal identity, relationships and goals. Methods: This is a multicentric, pragmatic pilot randomized controlled trial involving individuals who experienced the COVID-19 pandemic and underwent a lockdown and quarantine procedures. The trial is approved by the Ethics Committee of the Istituto Auxologico Italiano. Each research group in all the countries joining the pragmatic trial, aims at enrolling at least 30 individuals in the experimental group experiencing the self-help protocol, and 30 in the control group, over a period of 3 months to verify the feasibility of the intervention. Conclusion: The goal of this protocol is for VR to become the “surgical mask” of mental health treatment. Although surgical masks do not provide the wearer with a reliable level of protection against the coronavirus compared with FFP2 or FFP3 masks, surgical masks are very effective in protecting others from the wearer’s respiratory emissions. The goal of the VR protocol is the same: not necessarily to solve complex mental health problems but rather to improve well-being and preserve social connectedness.