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

Study Overview
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Brief Summary
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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
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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).

Official Title
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RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to Coronavirus-19: Study Protocol of a Randomized Controlled Trial

Conditions
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Psychological Disease

Intervention / Treatment
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* Other: internet-based intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RinasciMENTE<br>Participants will receive the internet-based intervention. | Other: internet-based intervention<br>* Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).<br>|
| No Intervention: Waiting-list<br>Participants will no receive the internet-based intervention. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress scale (PSS) | It evaluates the perceived stress by person | 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. | 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) | 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 | 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. | 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. | Baseline, 2 months follow-up, 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, internet-based intervention, cognitive-behavioral therapy