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| Name | Class |
|---|---|
| Bar-Ilan University, Israel | OTHER |
| Istituto Auxologico Italiano | OTHER |
| Linkoeping University | OTHER_GOV |
| Karolinska Institutet |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RinasciMENTE | Experimental | Participants will receive the internet-based intervention. |
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| Waiting-list | No Intervention | Participants will no receive the internet-based intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internet-based intervention | Other | Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months). |
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| Measure | Description | Time Frame |
|---|---|---|
| Outcome Questionnaire (OQ-45) | It measures the changes in adult patients thanks to intervention. | Baseline, 2 months follow-up, 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress scale (PSS) | It evaluates the perceived stress by person | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Bertuzzi | Contact | 347-4752286 | vanessa.bertuzzi@unicatt.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2022 | Mar 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2022 | Mar 7, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| OTHER |
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| 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) | 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 | 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. | 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. | Baseline, 2 months follow-up, 12 months follow-up |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |