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

• Published in: Current controlled trials in cardiovascular medicine Vol. 22; no. 1; pp. 171 - 11
• Main Authors: Brog, Noemi Anja, Hegy, Julia Katharina, Berger, Thomas, Znoj, Hansjörg
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 01.03.2021; BioMed Central; BMC
• Subjects: Adjustment; Anxiety; Anxiety - psychology; Anxiety - therapy; Care and treatment; Clinical trials; Coronavirus; Coronaviruses; COVID-19; Depression; Depression - psychology; Depression - therapy; Emotional Regulation; Humans; Informed consent; Internet access; Internet-Based Intervention; Internet-based self-help; Intervention; Loneliness; Mental depression; Mental disorders; Mental health; Mental illness; Methods; Online health care information services; Optimism; Pandemics; Patient education; Patient Health Questionnaire; Patient Satisfaction; Pessimism; Psychological Distress; Quality of Life; Questionnaires; Randomized Controlled Trials as Topic; Resilience, Psychological; SARS-CoV-2; Self Care; Self Efficacy; Self help; Self-care, Health; Self-Management; Stress; Stress management; Stress, Psychological - psychology; Stress, Psychological - therapy; Study Protocol; Suicidal behavior; Suicidal Ideation; Testing; Therapists; Switzerland; COVID-19; Coronavirus; Psychological distress; Depression; Anxiety; Internet-based self-help; Randomized controlled trial; Stress
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05089-9

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. 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. 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. ClinicalTrials.gov NCT04380909 . Retrospectively registered on 8 May 2020.