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The purpose of this study is to evaluate whether a forced isolation context (such provided by the ongoing Covid-19 pandemic restrictive measures) could reduce the burden of somatic symptoms among a group of patients with Somatic Symptom Disorder (SSD). Secondary objective is to assess if a reduction in terms of depression tendency and anxiety occurs in this specific population and which are the effect of such a context among a group of adolescents without SSD. We want to compare these results with data obtained at the end of the pandemic.
This study aims to evaluate whether the forced isolation context provided by the ongoing Covid-19 pandemic is providing an advantage in terms of reduction of somatic symptoms burden among an Italian group of adolescents with SSD, assessed by the Patient Health Questionnaire (PhQ15) administered during and at the end of the pandemic.
Secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSD group | Adolescents with SSD diagnosis made within previously six months or before unless assessed and confirmed by a specialist within the last six months |
| |
| Without SSD group | Control group: adolescents without diagnosis of SSD, matched with the SSD group by age and sex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forced isolation context | Other | Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean PhQ15 scale scores between T0 and T1 in the SSD adolescents group. | To SSD group, the Health Questionnaire Physical Symptoms (PhQ15) will be administrated to quantify the somatic symptom burden. | During the pandemic and within 6 months after the end |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean MASC2 scores between T0 and T1 in the SSD group. | SSD adolescents will receive the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items, to quantify adolescents' anxiety. | During the pandemic and within 6 months after the end |
| Difference in mean CDI-2 short questionnaire scores between T0 and T1 in the SSD group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Abbracciavento, MD | Institute for maternal and child health Burlo Garofolo | Study Chair |
| Laura De Nardi, MD | Institute for maternal and child health Burlo Garofolo | Principal Investigator |
| Andrea Trombetta, MD | Institute for maternal and child health Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Maternal and Child Health - IRCCS Burlo Garofolo- | Trieste | 34137 | Italy |
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SSD adolescents will receive the Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items, to quantify adolescents' depression. |
| During the pandemic and within 6 months after the end |
| Difference in mean MASC2 scores between T0 and T1 in the adolescents group without SSD diagnosis. | Adolescents without SSD will receive the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items, to quantify adolescents' anxiety | During the pandemic and within 6 months after the end |
| Difference in mean CDI-2 short questionnaires scores between T0 and T1 in the adolescents group without SSD diagnosis. | Adolescents without SSD will receive the Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items, to quantify adolescents' depression | During the pandemic and within 6 months after the end |
| Comparison between the two groups of adolescents in the mean T1-T0 differences for MASC2 scores. | Differences in the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items | During the pandemic and within 6 months after the end |
| Comparison between the two groups of adolescents in the mean T1-T0 differences for CDI-2 short questionnaires scores. | Differences in Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items | During the pandemic and within 6 months after the end |
| Description of adolescents' coping strategies during a pandemic isolation context among SSD and non-SSD adolescent | A general anonymous semi-structured survey will be administered to both the groups in order to investigate their habits, social media and videogames pattern of usage, and other leisure pattern of frequency. This will provide us a description of adolescents' general coping strategies during quarantine period. | During the pandemic |