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

March 31, 2023 updated by: IRCCS Burlo Garofolo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in mean PhQ15 scale scores between T0 and T1 in the SSD adolescents group.
Time Frame: 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.
During the pandemic and within 6 months after the end

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in mean MASC2 scores between T0 and T1 in the SSD group.
Time Frame: During the pandemic and within 6 months after the end
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.
Time Frame: During the pandemic and within 6 months after the end
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.
Time Frame: During the pandemic and within 6 months after the end
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.
Time Frame: During the pandemic and within 6 months after the end
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.
Time Frame: During the pandemic and within 6 months after the end
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.
Time Frame: During the pandemic and within 6 months after the end
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
Time Frame: During the pandemic
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Burlo Garofolo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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