Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project

Abstract

Background: This study aims to evaluate the feasibility and effectiveness of the RinasciMENTE program, an Internet-based self-help intervention based on cognitive behavioral therapy (CBT) principles and techniques in supporting individuals experiencing psychological impairments during the COVID-19 pandemic. A randomized controlled trial (RCT) design with random allocation at the level of individual will be conducted to compare the impact of the RinasciMENTE program with a waiting list control in improving the psychological functioning of the general population during the COVID-19 pandemic.

Methods: A minimum sample of 128 participants experiencing mild/subthreshold levels of psychological symptoms during the COVID-19 pandemic will be recruited. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 2 months, during which participants will receive 8 weekly CBT treatment modules. The impact of the RinasciMENTE program on selected primary and secondary psychological outcomes will be tested at the end of the intervention (2 months) and 6- and 12-month follow-ups.

Discussion: We expect people to show an increased level of psychological functioning and to acquire the skills and self-confidence necessary to deal with the psychological consequences of the COVID-19 outbreak and its related social isolation during and following the pandemic.

Trial registration: ClinicalTrials.gov NCT0497903 Registered on 28 May 2021.

Keywords: COVID-19; Clinical psychology; Cognitive-behavioral therapy; Internet-based intervention; Psychological distress; Randomized controlled trial; Self-help.