Department of Psychology, University of Bern, Fabrikstrasse 8, 3012, Bern, Switzerland.
Trials. 2021 Mar 1;22(1):171. 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.
冠状病毒-19（COVID-19）已达到大流行状态，正在影响世界各地的国家。COVID-19 大流行伴随着各种压力源，需要在日常生活中进行调整，并且可能需要改变个人的未来前景。虽然有些人能够很好地应对这些挑战，但有些人会出现心理困扰，包括抑郁症状、焦虑或压力。基于互联网的自助干预措施已被证明在治疗各种精神障碍（如抑郁和焦虑）方面非常有效。在此基础上，我们针对因 COVID-19 大流行而产生心理困扰的个体开发了一种基于互联网的自助干预措施。这个 3 周的自助计划包括 6 个模块，其中包含文本、视频、图片和练习。参与者可以在自助计划中请求指导（按需指导）。本研究的主要目的是评估与等待对照条件相比，该自助计划的疗效和可行性。
本研究设计为平行组随机对照试验。参与者被分配到为期 3 周的自助干预加常规护理或为期 3 周的仅常规护理的等待期。在 6 周和 18 周后进行随访。将招募至少 80 名因 COVID-19 大流行而产生心理困扰的参与者。主要结局指标为抑郁症状。次要结局指标包括焦虑和慢性压力、自杀经历和行为、健康相关生活质量、一般乐观和悲观、愤世嫉俗、乐观的自我信念、情绪调节技能、孤独感、韧性以及对自助计划的满意度和可用性。
据我们所知，这是第一项研究之一，旨在调查针对 COVID-19 大流行相关心理困扰的基于互联网的自助计划的疗效。因此，本研究的结果可能会进一步深入了解在与大流行相关的心理困扰中使用基于互联网的自助计划。
ClinicalTrials.gov NCT04380909. 于 2020 年 5 月 8 日进行了回顾性注册。
