RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19

Not Applicable

• Conditions: Psychological Disease
• Interventions: Other: internet-based intervention

• Registration Number: NCT04907903
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Study Start: 2022-09-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 18 years old or over and both gender
• Italian mother-tongue
• Score 14 or less on Patients Health Questionnaire-9 (PHQ-9)
• Internet access and basic informatic ability to navigate the internet platform
• Must be able to complete a phone interview

Exclusion Criteria

• Having severe and mental impairments, psychiatric condition and neurological disorder
• Not be able to use a computer or do not have internet access
• Not be able to complete a phone interview
• Score 15 or more on PHQ-9

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RinasciMENTE	internet-based intervention	Participants will receive the internet-based intervention.

Primary Outcome Measures

Name	Time	Method
Outcome Questionnaire (OQ-45)	Baseline, 2 months follow-up, 12 months follow-up	It measures the changes in adult patients thanks to intervention.

Secondary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life (WHOQOL)-BREF	Baseline, 2 months follow-up, 12 months follow-up	It detects four dimensions of quality of life: physical health, psychological health, social relations and environment.
Depression Anxiety Stress Scales-Short Version (DASS-21)	Baseline, 2 months follow-up, 12 months follow-up	It allows to observe three dimensions (depression, anxiety and stress)
General Self-efficacy Scale (GSES)	Baseline, 2 months follow-up, 12 months follow-up	It evaluates the confidence of subjects in their ability to cope with a variety of difficult or stressing situations.
Perceived stress scale (PSS)	Baseline, 2 months follow-up, 12 months follow-up	It evaluates the perceived stress by person
Emotional regulation questionnaire (ERQ)	Baseline, 2 months follow-up, 12 months follow-up	It measures how respondents regulate their emotions through two dimensions: cognitive revaluation and expressive suppression.
Fear of COVID-19 Scale (FCV-19S)	Baseline, 2 months follow-up, 12 months follow-up	It evaluates how subjects show fear relative to the recent pandemic of Coronavirus