RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19
1 other identifier
interventional
128
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 27, 2022
July 1, 2022
3 months
April 7, 2021
July 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Outcome Questionnaire (OQ-45)
It measures the changes in adult patients thanks to intervention.
Baseline, 2 months follow-up, 12 months follow-up
Secondary Outcomes (6)
Perceived stress scale (PSS)
Baseline, 2 months follow-up, 12 months follow-up
Emotional regulation questionnaire (ERQ)
Baseline, 2 months follow-up, 12 months follow-up
Depression Anxiety Stress Scales-Short Version (DASS-21)
Baseline, 2 months follow-up, 12 months follow-up
Fear of COVID-19 Scale (FCV-19S)
Baseline, 2 months follow-up, 12 months follow-up
General Self-efficacy Scale (GSES)
Baseline, 2 months follow-up, 12 months follow-up
- +1 more secondary outcomes
Study Arms (2)
RinasciMENTE
EXPERIMENTALParticipants will receive the internet-based intervention.
Waiting-list
NO INTERVENTIONParticipants will no receive the internet-based intervention.
Interventions
Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catholic University of the Sacred Heartlead
- Bar-Ilan University, Israelcollaborator
- Istituto Auxologico Italianocollaborator
- Linkoeping Universitycollaborator
- Karolinska Institutetcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
April 7, 2021
First Posted
June 1, 2021
Study Start
September 1, 2022
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
July 27, 2022
Record last verified: 2022-07