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Trials
Published in: Trials 1/2021

Open Access 01-12-2021 | Coronavirus | Study protocol

An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Authors: Noemi Anja Brog, Julia Katharina Hegy, Thomas Berger, Hansjörg Znoj

Published in: Trials | Issue 1/2021

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Abstract

Background

The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition.

Methods

The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program.

Discussion

To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress.

Trial registration

ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.
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Metadata
Title
An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial
Authors
Noemi Anja Brog
Julia Katharina Hegy
Thomas Berger
Hansjörg Znoj
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05089-9

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