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

NCT05795803 | Completed

• 1 other identifier: RC 11/2020
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatic Symptom Disorder

Keywords

SSD; adolescents; coping strategies; social media

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Difference in mean MASC2 scores between T0 and T1 in the SSD group.

  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.

  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.

  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.

  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.

  During the pandemic and within 6 months after the end

Study Arms (2)

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

Without SSD group

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

Other: Forced isolation context

Interventions

Forced isolation context OTHER

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

Also known as: COVID-19 lockdown

SSD group; Without SSD group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Location

Study Officials

• Giuseppe Abbracciavento, MD

  Institute for maternal and child health Burlo Garofolo

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: April 3, 2023
• Study Start: April 1, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

IT (1)