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Completed

NCT Number: NCT05795803

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

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.

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Key information

Conditions

Somatic Symptom Disorder

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Forced isolation context

Other

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

Other names: COVID-19 lockdown

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2023
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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