NCT04324190

DIgital Online SuPport for COVID-19 StrEss

Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Gunther Meinlschmidt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The COVID-19 pandemic leads to a greatly increased risk of substantial psychological stress worldwide. We intend to evaluate an online support program aiming at reducing stress in the context of the COVID-19 pandemic. The program consists of twelve modules that participants undergo, covering a broad range of topics related to stress in the context of the COVID-19 pandemic. It has been developed together with and is provided by Selfapy GmbH, Berlin. The aim of this randomised clinical trial with observational components is to estimate the effects of the intervention as a whole, as well as individual modules and selected chapters. Further, follow-up assessments as well as information on risks and the long-term course of COVID pandemic-related stress may help to elucidate COVID-19 pandemic stress across time and what we can do to prevent long-term negative consequences.

Detailed description

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.

Conditions

• COVID-19
• Psychosocial Stress
• Mental Health

Interventions

Type	Name	Description
BEHAVIORAL	Guided online support program	Guided online support program consisting of several modules; Module "General information ..." is an unspecific control module (providing general information on hygiene etc. with no expected effect on outcomes)
BEHAVIORAL	WHO recommendations (waiting condition)	During the waiting period, a german translation of the WHO recommendations "Coping with stress during the 2019-nCoV outbreak" is provided

Timeline

• Start date: 2020-04-08
• Primary completion: 2020-06-01
• Completion: 2021-12-01
• First posted: 2020-03-27
• Last updated: 2020-04-14

Locations

1 site across 1 country: Germany