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

July 26, 2022 updated by: Vanessa Bertuzzi, Catholic University of the Sacred Heart

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Questionnaire (OQ-45)
Time Frame: Baseline, 2 months follow-up, 12 months follow-up
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)
Time Frame: Baseline, 2 months follow-up, 12 months follow-up
It evaluates the perceived stress by person
Baseline, 2 months follow-up, 12 months follow-up
Emotional regulation questionnaire (ERQ)
Time Frame: Baseline, 2 months follow-up, 12 months follow-up
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)
Time Frame: Baseline, 2 months follow-up, 12 months follow-up
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)
Time Frame: Baseline, 2 months follow-up, 12 months follow-up
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)
Time Frame: 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.
Baseline, 2 months follow-up, 12 months follow-up
World Health Organization Quality of Life (WHOQOL)-BREF
Time Frame: 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.
Baseline, 2 months follow-up, 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Collaborators

Karolinska Institutet
Linkoeping University
Istituto Auxologico Italiano
Bar-Ilan University, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (ACTUAL)

June 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychological Disease

Clinical Trials on internet-based intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe