Psychotherapeutic and Psychiatric Intervention in Patients With COVID-19 and Their Relatives: Protocol for the DigiCOVID Trial

Abstract

Background The COVID-19 pandemic is negatively impacting the mental health of both patients with COVID-19 and the general population. As current guidelines are limiting in-person contacts to reduce the spread of the virus, the development of a digital approach to implement in psychiatric and psychological consultations is needed. In this paper, we present the DigiCOVID protocol, a digital approach to offer remote, personalized psychological and psychiatric support to former or current patients with COVID-19 and their relatives. Objective The main goal of this project is to evaluate the feasibility, acceptability, and usability of the DigiCOVID protocol. Furthermore, we also aim to assess the impact of the abovementioned protocol by means of pre-post changes in psychological clinical variables. Methods Participants undergo an initial telephonic screening to ensure inclusion criteria are met. Secondly, participants complete a video-assisted neuropsychological IQ test as well as web-based self-reports of health and general well-being. Participants are then assigned to a psychotherapist who offers 8 teletherapy sessions. At the end of the therapy cycle, the web-based questionnaires are administered for a posttreatment evaluation. Results As of April 2022, we enrolled a total of 122 participants, of which 94 have completed neuropsychological tests and web-based questionnaires. Conclusions Our study aims at testing the feasibility and preliminary efficacy of DigiCOVID, a remote telemedicine protocol for the improvement of psychological and psychiatric health in patients with COVID-19 and their relatives. To date, the approach used seems to be feasible and highly customizable to patients’ needs, and therefore, the DigiCOVID protocol might pave the way for future telepsychiatry-based interventions. Trial Registration ClinicalTrials.gov NCT05231018; https://clinicaltrials.gov/ct2/show/NCT05231018?term=NCT05231018 &draw=2&rank=1 International Registered Report Identifier (IRRID) DERR1-10.2196/39080

Digital therapeutics in the clinic

“…Among the respiratory disease‐focused trials, COPD, Asthma, tuberculosis, and COVID‐19 were the most commonly investigated diseases. Within these trials, DTx can be paired with a device such as a smart inhaler that can monitor the patient's adherence to their regular therapy and recommend courses of action to take 81 ; in the case of COVID‐19, patients could use DTx to aid in mentally coping with the effects of long‐term COVID through their mobile devices 82 . The cardiovascular disease‐focused trials focused on managing heart failure, vascular disease, ventricular contractions, myocardia, hypotension, atrial fibrillation, and coronary heart disease.…”

“…Within these trials, DTx can be paired with a device such as a smart inhaler that can monitor the patient's adherence to their regular therapy and recommend courses of action to take 81 ; in the case of COVID‐19, patients could use DTx to aid in mentally coping with the effects of long‐term COVID through their mobile devices. 82 The cardiovascular disease‐focused trials focused on managing heart failure, vascular disease, ventricular contractions, myocardia, hypotension, atrial fibrillation, and coronary heart disease. Within this category, the DTx were personalized to patient education of their disease state 83 and remote monitoring to lower the number of emergency department visits.…”