Effects of a Pandemic Forced Isolation Context on Adolescents With Somatic Symptom Disorder. A Panel Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Difference in mean PhQ15 scale scores between T0 and T1 in the SSD adolescents group.
研究概览
简要总结
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.
详细描述
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:
- To investigate the difference in anxiety and depression scores assessed by the Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory (CDI-2) questionnaires among a group of SSD adolescents, during and after the pandemic isolation context.
- To investigate the difference in anxiety and depression scores assessed by the Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory (CDI-2) questionnaires among a group of adolescents without SSD, during and after the pandemic isolation context.
- To compare the difference in anxiety and depression scores time modification between the two groups of adolescents.
- To explore through tailored questions which adolescents' coping strategies are during a pandemic isolation context among SSD patients and a group of controls without SSD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged between 12 and 17 years old who received a diagnosis of SSD within the last six months or before unless assessed and confirmed by a specialist within the last six months
- •Adolescents without a diagnosis of SSD, who previously accessed the Institute for maternal and child health "Burlo Garofolo" Emergency Department for traumatic injuries or the Pediatric Clinic/Day Hospital Service for oral immunotherapy because of food allergies.
- •Adolescents experiencing a quarantine period during the Covid19 pandemic.
排除标准
- •Adolescents with cognitive impairment.
- •Adolescents with chronic diseases.
- •Adolescents with other neuropsychiatric disorders according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM V).
- •For the group without SSD diagnosis, any access to Emergency Department for unexplained chronic pain or any history of other psychiatric comorbidities.
结局指标
主要结局
Difference in mean PhQ15 scale scores between T0 and T1 in the SSD adolescents group.
时间窗: During the pandemic and within 6 months after the end
To SSD group, the Health Questionnaire Physical Symptoms (PhQ15) will be administrated to quantify the somatic symptom burden.
次要结局
- Comparison between the two groups of adolescents in the mean T1-T0 differences for CDI-2 short questionnaires scores.(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.(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.(During the pandemic and within 6 months after the end)
- Difference in mean MASC2 scores between T0 and T1 in the SSD group.(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.(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.(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(During the pandemic)