DIgital Online SuPport for COVID-19 StrEss

The overall aim of this randomised trial with observational component is to estimate the
effects of a guided digital online support program to increase mental health and reduce
psychosocial stress in the context of the COVID-19 pandemic. More specifically, the main
hypothesis is to estimate whether the improvement in mental health is stronger during the
first two weeks of applying the online support program as compared to a two weeks waiting
condition (with provision of WHO information on 'coping with stress during the 2019-nCoV'
outbreak only). In addition to the randomised control group (second arm: waiting condition,
followed by online support program), the study comprises as third arm a non-randomised
comparator condition, consisting of subjects not intending to participate in the online
support program. Furthermore, our aim is to estimate changes in the outcomes along taking
part in the program.

Additional research questions are:

- to compare the intervention effects across modules and chapters of the online support
program, including between module comparison with an unspecific, control (comparator)
module: "general information on the corona virus" and its unspecific chapters;

- to estimate the effects of selected modules on additional outcomes (e.g. physical
activity, and schooling related factors);

- to describe the magnitude and course of psychosocial stress, mental health and related
factors in the context of the COVID-19 pandemic;

- to estimate and predict which subjects profit most from specific parts of the program.

Follow-up assessment shall include estimating whether the program prevents the development of
detrimental mental health conditions, e.g. depression, anxiety, etc.

In order to make first study results available as early as possible, we intend to conduct
quick complete analyses (primary outcome and relevant parts of secondary/other outcomes):
These analyses will be conducted with data including subjects from the first 4 weeks of
recruitment, given that a sample size of at least 300 for the online support program arm and
a sample size of at least 300 for the waiting condition is reached; or if not yet reached
after 4 weeks of recruitment, as soon as a sample size of at least 300 for the online support
program arm and a sample size of at least 300 for the waiting condition is reached. However,
we intend to continue recruiting beyond this point in time and sample size (until the
COVID-19 pandemic situation has come to an end, i.e., vaccination is broadly available), to
allow further, also more detailed analyses at a later point in time, resulting in more
precise estimates.