E-mental health mindfulness-based and skills-based 'CoPE It' intervention to reduce psychological distress in times of COVID-19: study protocol for a bicentre longitudinal study.
BMJ open. 2020;(8):e039646
INTRODUCTION The SARS-CoV-2 (COVID-19) pandemic poses immense challenges for national and international healthcare systems. Especially in times of social isolation and governmental restrictions, mental health should not be neglected. Innovative approaches are required to support psychologically burdened people. The e-mental health intervention 'CoPE It' has been developed to offer manualised and evidence-based psychotherapeutic support adapted to COVID-19-related issues in order to overcome psychological distress. In our study, we aim to assess the efficacy of the e-mental health intervention 'CoPE It' in terms of reducing distress (primary outcome), depression and anxiety symptoms as well as improving self-efficacy, quality of life and mindfulness (secondary outcomes). Furthermore, we want to evaluate the programme's usability, feasibility and participants' satisfaction with 'CoPE It' (tertiary outcome). METHODS AND ANALYSIS The e-mental health intervention 'CoPE It' consists of four 30 min modules, conducted every other day, involving psychotherapeutic techniques of mindfulness-based stress reduction and cognitive-behavioural therapy. The widely applied and previously established content has been adapted to the context of the COVID-19 pandemic by experts in psychosomatic medicine and stress prevention. In our longitudinal study, adult participants-with adequate German language and computer skills, and who have provided informed consent-will be recruited via emergency support hotlines in Germany. Flyers will be distributed, and online channels will be used. Participants will complete a baseline assessment (T0), a postintervention assessment (T1) and assessments 1 and 3 months later (T2 and T3, respectively). We will perform repeated measures analysis of covariance, mixed linear models, standard analyses of variance and regression, and correlation coefficients. In case of binary outcome variables, either mixed logistic regression or χ² tests will be used. ETHICS AND DISSEMINATION The Ethics Committees of the University of Duisburg-Essen (20-9243-BO) and University of Tübingen (469/2020BO) approved the study. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER DRKS00021301.