Effects of COVID-19 Forced Isolation Context on Adolescents With and Without Somatic Symptom Disorder

Somatic Symptom Disorder Clinical Trial

Official title:

Effects of a Pandemic Forced Isolation Context on Adolescents With Somatic Symptom Disorder. A Panel Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05795803
• Other study ID #: RC 11/2020
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2023
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

Other:
• Forced isolation context
Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	During the pandemic and within 6 months after the end
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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