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

NCT ID: NCT05795803

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-05-31

Brief 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.

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.

Conditions

Somatic Symptom Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Forced isolation context

Intervention Type: OTHER

Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures

Without SSD group

Control group: adolescents without diagnosis of SSD, matched with the SSD group by age and sex

Forced isolation context

Intervention Type: OTHER

Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures

Interventions

Forced isolation context

Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures

Intervention Type: OTHER

Other Intervention Names

COVID-19 lockdown

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Abbracciavento, MD

Role: STUDY_CHAIR

Institute for maternal and child health Burlo Garofolo

Laura De Nardi, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for maternal and child health Burlo Garofolo

Andrea Trombetta, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for maternal and child health Burlo Garofolo

Locations

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, , Italy

Countries

Italy

Other Identifiers

RC 11/2020

Identifier Type: -

Identifier Source: org_study_id