This study aims is the evaluation of the efficacy and feasibility of RinasciMENTE, the Randomized Controlled Clinical Trial compared with a waiting list control group.
A sample of 128 participants, who experience psychological discomfort due to COVID-19, will be recruited. After initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. Measures will be taken at the baseline (T0), at the end of the treatment (T1) and 12 months follow-up (T2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
128
Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).
Outcome Questionnaire (OQ-45)
It measures the changes in adult patients thanks to intervention.
Time frame: Baseline, 2 months follow-up, 12 months follow-up
Perceived stress scale (PSS)
It evaluates the perceived stress by person
Time frame: Baseline, 2 months follow-up, 12 months follow-up
Emotional regulation questionnaire (ERQ)
It measures how respondents regulate their emotions through two dimensions: cognitive revaluation and expressive suppression.
Time frame: Baseline, 2 months follow-up, 12 months follow-up
Depression Anxiety Stress Scales-Short Version (DASS-21)
It allows to observe three dimensions (depression, anxiety and stress)
Time frame: Baseline, 2 months follow-up, 12 months follow-up
Fear of COVID-19 Scale (FCV-19S)
It evaluates how subjects show fear relative to the recent pandemic of Coronavirus
Time frame: Baseline, 2 months follow-up, 12 months follow-up
General Self-efficacy Scale (GSES)
It evaluates the confidence of subjects in their ability to cope with a variety of difficult or stressing situations.
Time frame: Baseline, 2 months follow-up, 12 months follow-up
World Health Organization Quality of Life (WHOQOL)-BREF
It detects four dimensions of quality of life: physical health, psychological health, social relations and environment.
Time frame: Baseline, 2 months follow-up, 12 months follow-up
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