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

Catholic University of the Sacred Heart

Status: Not yet enrolling

Conditions: Psychological Disease

Treatments: Other: internet-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04907903

25-21

Details and patient eligibility

About

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.

Full 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).

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

RinasciMENTE

Experimental group

Description:

Participants will receive the internet-based intervention.

Treatment:

Other: internet-based intervention

Waiting-list

No Intervention group

Description:

Participants will no receive the internet-based intervention.