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.
Trials
; 23(1): 801, 2022 Sep 24.
Article
in English
| MEDLINE | ID: covidwho-2043136
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Internet-Based Intervention
/
Psychological Distress
/
COVID-19
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2022
Document Type:
Article
Affiliation country:
S13063-022-06714-x
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