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

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

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.

Study Overview

• Status: Completed
• Conditions: Somatic Symptom Disorder
• Intervention / Treatment: Other: Forced isolation context

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• SSD group: Adolescents who received a diagnosis of SSD at the Institute for maternal and child health "Burlo Garofolo"
• Without SSD group: Adolescents who accessed the Emergency Department for traumatic injuries or the Pediatric Clinic/Day Hospital Service for oral immunotherapy because of food allergies.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Forced isolation context; Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures; Other Names: COVID-19 lockdown
Without SSD group; 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; Other Names: COVID-19 lockdown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Giuseppe Abbracciavento, MD, Institute for maternal and child health Burlo Garofolo; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: adolescents; social media; coping strategies; SSD
• Additional Relevant MeSH Terms: Medically Unexplained Symptoms
• Other Study ID Numbers: RC 11/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No