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

NCT ID: NCT04907903

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-01

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).

Conditions

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Psychological Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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RinasciMENTE

Participants will receive the internet-based intervention.

Group Type EXPERIMENTAL

internet-based intervention

Intervention Type OTHER

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

Waiting-list

Participants will no receive the internet-based intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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internet-based intervention

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Bertuzzi

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Vanessa Bertuzzi

Role: CONTACT

347-4752286

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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25-21

Identifier Type: -

Identifier Source: org_study_id

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