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

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 Sep 24

PMID 36153586

Authors

Vanessa Bertuzzi

Michelle Semonella

Gerhard Andersson

Gian Mauro Manzoni

Gianluca Castelnuovo

Enrico Molinari

Giada Pietrabissa

Affiliations

Soon will be listed here.

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.

Citing Articles

Internet-delivered emotional self-management program for the general population during the COVID-19 pandemic: Usability testing.

Semonella M, Marchesi G, Castelnuovo G, Andersson G, Pietrabissa G Digit Health. 2024; 10:20552076241258419.

PMID: 39314812 PMC: 11418310. DOI: 10.1177/20552076241258419.

Validation of the Italian Version of the Web Screening Questionnaire for Common Mental Disorders.

Pietrabissa G, Semonella M, Marchesi G, Mannarini S, Castelnuovo G, Andersson G J Clin Med. 2024; 13(4).

PMID: 38398481 PMC: 10889998. DOI: 10.3390/jcm13041170.

Correction: 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.

Bertuzzi V, Semonella M, Andersson G, Manzoni G, Castelnuovo G, Molinari E Trials. 2023; 24(1):201.

PMID: 36932452 PMC: 10022985. DOI: 10.1186/s13063-023-07217-z.

Synthesizing Stakeholders Perspectives on Online Psychological Interventions to Improve the Mental Health of the Italian Population during the COVID-19 Pandemic: An Online Survey Study.

Bertuzzi V, Semonella M, Castelnuovo G, Andersson G, Pietrabissa G Int J Environ Res Public Health. 2022; 19(12).

PMID: 35742257 PMC: 9222987. DOI: 10.3390/ijerph19127008.

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