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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04907903

Enrollment

128

Registered

2021-06-01

Start date

2022-09-01

Completion date

2023-06-01

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Disease

Keywords

COVID-19, internet-based intervention, cognitive-behavioral therapy

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).

Interventions

OTHERinternet-based intervention

Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactVanessa Bertuzzi

vanessa.bertuzzi@unicatt.it347-4752286

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026