Psychological DiseaseNCT04907903
RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19
A study testing internet-based intervention in people with Psychological Disease, run by Catholic University of the Sacred Heart.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Disease
- What is being tested?
- internet-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Psychological Disease
- Being tested
- internet-based intervention
- Keywords
- COVID-19, internet-based intervention, cognitive-behavioral therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based interventionOther
Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).
| Study group | Role | What they receive |
|---|---|---|
| RinasciMENTE | Experimental | Participants will receive the internet-based intervention. Receives: Other: internet-based intervention |
| Waiting-list | No intervention | Participants will no receive the internet-based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Questionnaire (OQ-45)
It measures the changes in adult patients thanks to intervention.
Measured: Baseline, 2 months follow-up, 12 months follow-up
Secondary outcomes (6)
Perceived stress scale (PSS)
It evaluates the perceived stress by person
Measured: Baseline, 2 months follow-up, 12 months follow-up
Emotional regulation questionnaire (ERQ)
It measures how respondents regulate their emotions through two dimensions: cognitive revaluation and expressive suppression.
Measured: Baseline, 2 months follow-up, 12 months follow-up
Depression Anxiety Stress Scales-Short Version (DASS-21)
It allows to observe three dimensions (depression, anxiety and stress)
Measured: Baseline, 2 months follow-up, 12 months follow-up
Fear of COVID-19 Scale (FCV-19S)
It evaluates how subjects show fear relative to the recent pandemic of Coronavirus
Measured: Baseline, 2 months follow-up, 12 months follow-up
General Self-efficacy Scale (GSES)
It evaluates the confidence of subjects in their ability to cope with a variety of difficult or stressing situations.
Measured: Baseline, 2 months follow-up, 12 months follow-up
World Health Organization Quality of Life (WHOQOL)-BREF
It detects four dimensions of quality of life: physical health, psychological health, social relations and environment.
Measured: Baseline, 2 months follow-up, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Bar-Ilan University, Israel, Istituto Auxologico Italiano, Linkoeping University, Karolinska Institutet
- Responsible party
- Principal investigator, Vanessa Bertuzzi, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907903
- Sponsor's protocol ID
- 25-21
- Status last verified
- Jul 2022
- First submitted
- 7 Apr 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04907903
- Acronym / sponsor ID
- 25-21
- Conditions
- Psychological Disease
- Keywords
- COVID-19, internet-based intervention, cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Bar-Ilan University, Israel, Istituto Auxologico Italiano, Linkoeping University, Karolinska Institutet
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RinasciMENTE | Experimental | Other: internet-based interventionParticipants will receive the internet-based intervention. |
| Waiting-list | No intervention | –Participants will no receive the internet-based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-based interventionIntervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months). | Other | RinasciMENTE |
Primary outcome
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.
6 secondary outcomes
Perceived stress scale (PSS)
Time frame: Baseline, 2 months follow-up, 12 months follow-up
Emotional regulation questionnaire (ERQ)
Time frame: 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
Fear of COVID-19 Scale (FCV-19S)
Time frame: 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
World Health Organization Quality of Life (WHOQOL)-BREF
Time frame: Baseline, 2 months follow-up, 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based intervention in people with Psychological Disease, run by Catholic University of the Sacred Heart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Bertuzzi (347-4752286, vanessa.bertuzzi@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Questionnaire (OQ-45) (time frame: Baseline, 2 months follow-up, 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.