Background The COVID-19 pandemic and its far-reaching impact on physical and mental health generate high demand and, accordingly, a great need for treatment opportunities that promote well-being and manage psychological distress. Internet-based interventions are particularly suitable for this purpose. They are easily scalable, readily accessible, and the online format allows for adherence to social distancing. For this reason, we developed an internet-based self-help intervention called ROCO to address psychological distress due to the COVID-19 pandemic. This randomized controlled trial aimed to examine the efficacy of the ROCO intervention. Methods A total of 107 German-speaking adults with at least mild depressive symptoms were randomized either to the intervention group with direct access to the three-week ROCO intervention plus care as usual or the waiting control group receiving care as usual. Primary outcome (depressive symptoms) and secondary outcomes (stress, anxiety, resilience, emotion regulation, health-related quality of life, embitterment, loneliness, optimism, and self-efficacy) were assessed pre- and post-treatment and at a 6-week follow-up using self-report questionnaires (e.g. Patient Health Questionnaire-9 for depressive symptoms). Results The average age was 40.36 years (SD = 14.59) and 81.3% of participants were female. The intervention did not significantly reduce primary depressive symptoms (between-group effect size: d = 0.04) and secondary outcomes such as anxiety and stress symptoms (between-group effect size: d = −0.19). However, the intervention led to a significant increase in emotion regulation skills (between-group effect size d = 0.35) and resilience (between-group effect size d = 0.38). Conclusions The internet-based self-help intervention cannot be recommended for the purpose of reducing depressive symptoms. However, the increase in emotion regulation skills and resilience suggest that the intervention may be suitable for preventive purposes, like improving overall coping with psychological distress or potential stressors. Future research is needed to examine for whom and how the intervention is most effective.

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 behaviour, 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, https://clinicaltrials.gov/ct2/show/NCT04380909

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.

IntroductionFirst evidence suggests that internet-based self-help interventions effectively reduce COVID-19 related psychological distress. However, it is yet unclear which participant characteristics are associated with better treatment outcomes. Therefore, we conducted secondary analyses on data from a randomized controlled trial investigating the efficacy of a 3-week internet-based self-help intervention for COVID-19 related psychological distress. In this exploratory analysis, we examined several predictors ranging from sociodemographic variables to psychological distress, resource-related, and treatment-related variables. This includes, for example, age, motivation, and emotion regulation skills. Treatment outcomes were defined as post-treatment depressive symptoms and post-treatment resilience.MethodsIn a total of 107 participants with at least mild depressive symptoms, possible predictor variables and treatment outcomes were assessed using self-report measures. For example, emotion regulation skills were assessed by the Self-report measure for the assessment of emotion regulation skills. In a first step, we performed a separate linear regression analysis for each potential predictor. In a second step, predictors meeting a significant threshold of p < 0.05 were entered in linear multiple regression models. Baseline scores of the respective outcome measure were controlled for.ResultsThe mean age of the participants was 40.36 years (SD = 14.59, range = 18–81 years) with the majority being female (n = 87, 81.3%). Younger age predicted lower post-treatment depressive symptoms. Additionally, higher motivation to use the intervention and better pre-treatment emotion regulation skills predicted higher post-treatment resilience.ConclusionThe current study provides preliminary evidence regarding the relationship between participant characteristics and treatment outcome in internet-based self-help interventions for COVID-19 related distress. Our results suggest that under the circumstances surrounding COVID-19 such interventions might be particularly beneficial for young adults regarding depressive symptoms. Moreover, focusing on participants' existing strengths might be a promising approach to promote resilience through internet-based self-help interventions. However, since this was an exploratory analysis in an uncontrolled setting, further studies are needed to draw firm conclusions about the relationship of participant characteristics and treatment outcome in internet-based self-help interventions for COVID-19 related psychological distress.

Background Accidents and the resulting injuries are among the world’s biggest health care issues, often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT (German acronym: Selber wieder fit nach einem Unfall; “fit again after an accident”) aims to remedy this situation by offering a low-threshold, web-based self-help intervention for psychological distress after an accident. Objective The overall aim is to evaluate the efficacy and cost-effectiveness of the SelFIT program plus care as usual (CAU) compared to only CAU. Furthermore, the program’s user-friendliness, acceptance, and adherence are assessed. We expect that the use of SelFIT will be associated with a greater reduction in psychological distress, greater improvement in mental and physical well-being, and greater cost-effectiveness compared to CAU. Methods Adults (n=240) experiencing adjustment problems due to an accident they had between 2 weeks and 2 years before entering the study will be randomized into either the intervention or control group. Participants in the intervention group receive direct access to SelFIT. The control group receives access to the program after 12 weeks. There are 6 measurement points for both groups (baseline as well as after 4, 8, 12, 24, and 36 weeks). The main outcome is a reduction in anxiety, depression, and stress symptoms that indicate adjustment problems. Secondary outcomes include well-being, optimism, embitterment, self-esteem, self-efficacy, emotion regulation, pain, costs of health care consumption, and productivity loss, as well as the program’s adherence, acceptance, and user-friendliness. Results Recruitment began in December 2019 and will continue at least until January 2021, with the option to extend this for another 6 months until July 2021. As of July 2020, 324 people have shown interest in participating, and 48 people have given their informed consent. Conclusions To the best of our knowledge, this is the first study examining a web-based self-help program designed to treat adjustment problems resulting from an accident. If effective, the program could complement the still limited offerings for secondary and tertiary prevention of psychological distress after an accident. Trial Registration ClinicalTrials.gov NCT03785912; https://clinicaltrials.gov/ct2/show/NCT03785912 International Registered Report Identifier (IRRID) DERR1-10.2196/21200