An observational study in Somatic Symptom Disorder, sponsored by IRCCS Burlo Garofolo. Completed at 1 site in Italy. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by IRCCS Burlo Garofolo · Observational
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:
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 115 is below the median of 300 across 17 observational studies indexed under Medically Unexplained Symptoms.
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Exclusion Criteria:
Adolescents with SSD diagnosis made within previously six months or before unless assessed and confirmed by a specialist within the last six months
Other: Forced isolation context
Control group: adolescents without diagnosis of SSD, matched with the SSD group by age and sex
Other: Forced isolation context
Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures
Also known as: COVID-19 lockdown
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.
Time frame: During the pandemic and within 6 months after the end
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.
Time frame: 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.
SSD adolescents will receive the Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items, to quantify adolescents' depression.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: During the pandemic
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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IRCCS Burlo Garofolo