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

Psychological Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04907903
• Other study ID #: 25-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Catholic University of the Sacred Heart
• Contact: Vanessa Bertuzzi
• Phone: 347-4752286
• Email: vanessa.bertuzzi[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychological Disease

Intervention

Other:
• internet-based intervention
Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Bar-Ilan University, Israel, Istituto Auxologico Italiano, Karolinska Institutet, Linkoeping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Questionnaire (OQ-45)	It measures the changes in adult patients thanks to intervention.	Baseline, 2 months follow-up, 12 months follow-up
Secondary	Perceived stress scale (PSS)	It evaluates the perceived stress by person	Baseline, 2 months follow-up, 12 months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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