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Clinical Trial Summary

The SARS-CoV-2 pandemic, and the associated government-imposed isolationary lockdowns, has led to a mental health crisis on a global scale. Empirical studies have reported a drastic increase in mental health problems, such as depression and anxiety, increased loneliness and feelings of disconnectedness from others, while resilience levels have been negatively affected, indicating an urgent need for intervention. The current study study is embedded in a larger study, the CovSocial study (www.covsocial) which focused in its first phase on evaluating the longitudinal changes in vulnerability, resilience and social cohesion during the SARS-CoV-2 pandemic. The present second phase of this CovSocial study will seek to investigate the efficacy of brief online mindfulness-based and socio-emotional interventions in reducing mental health problems, and enhancing psychological resilience, social competencies and social cohesion. After providing informed consent, participants will be assigned to one of three groups: 1) socio-emotional training group (with Affect Dyads as core exercise), 2) mindfulness-based mental training group (with attention-based mindfulness practices such as Breathing Meditation as core practice), or 3) Retest Control Group (waitlist control).All groups will first undergo a pre-intervention testing phase (pre-test) wherein they will provide a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and behavioral tasks), and biological parameters (saliva samples). During the 10-week intervention period, participants will undergo weekly assessments and daily Ecological Momentary Assessment pre and post the daily exercise practice, using self-report scales and questionnaires delivered through a webapp or mobile app. At the end of the intervention, participants will again undergo an assessment of psychometric measures and biological parameters, same as at pre-intervention time (post-test). In a second portion, the waitlist control group will undergo the socio-emotional intervention and will be tested at post-test II again. Results will reveal the effectiveness of brief online interventions in enhancing mental health and social cohesion outcomes. In addition to examining pre-post intervention-related changes, we will also use the data from the phase 1 of the project to evaluate the impact of trait markers of and the longitudinal changes in vulnerability, resilience and social cohesion on the intervention-related changes in markers of vulnerability, resilience and social cohesion. We will also evaluate the predictive impact of genetic markers of vulnerability, resilience and social cohesion (assessed in phase 1) on intervention-related changes in our variables of interest. The present study will serve as a pilot for future application of scalable, low-cost interventions at a broader level to reduce stress, improve mental health and build resilience in the face of global stressors.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT04889508
Study type Interventional
Source Max Planck Social Neuroscience Lab
Contact
Status Completed
Phase N/A
Start date May 7, 2021
Completion date March 31, 2022

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