Somatic Symptom DisorderNCT05795803

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

An observational study of Somatic Symptom Disorder, run by IRCCS Burlo Garofolo at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Somatic Symptom Disorder
What is being tested?: Forced isolation context
How many people: 115 participants
Where: 1 siteItaly
Study dates: 1 Apr 2020to 31 May 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

Other trials in Italy

About this study

Official title: 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.

Read the 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
Being tested: Forced isolation context
Keywords: SSD, adolescents, coping strategies, social media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Forced isolation contextOther
Also called COVID-19 lockdown
Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures

Study groups in NCT05795803
Study group	Role	What they receive
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 Receives: Other: Forced isolation context
Without SSD group		Control group: adolescents without diagnosis of SSD, matched with the SSD group by age and sex Receives: Other: Forced isolation context

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
SSD adolescents will receive the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items, to quantify adolescents' anxiety.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: During the pandemic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202031 May 2020

First posted3 Apr 2023
Study start1 Apr 2020
Primary completion31 May 2020
Study completion31 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Somatic Symptom DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05795803
Sponsor's protocol ID: RC 11/2020
Status last verified: Mar 2023
First submitted: 11 May 2020
Last updated: 3 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Somatic Symptom Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Pandemic Forced Isolation Context on Adolescents With Somatic Symptom Disorder. A Panel Study
ClinicalTrials.gov ID: NCT05795803
Acronym / sponsor ID: RC 11/2020
Conditions: Somatic Symptom Disorder
Keywords: SSD, adolescents, coping strategies, social media
Study type: Observational
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: IRCCS Burlo GarofoloUniversity, hospital or other
Study start: 1 Apr 2020 (actual)
Primary completion: 31 May 2020 (actual)
Study completion: 31 May 2020 (actual)
First posted: 3 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
SSD group	–	Other: Forced isolation contextAdolescents with SSD diagnosis made within previously six months or before unless assessed and confirmed by a specialist within the last six months
Without SSD group	–	Other: Forced isolation contextControl group: adolescents without diagnosis of SSD, matched with the SSD group by age and sex

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Forced isolation contextAlso: COVID-19 lockdownExposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures	Other	SSD group, Without SSD group

Primary outcome

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.

7 secondary outcomes

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
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
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
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
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
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
Description of adolescents' coping strategies during a pandemic isolation context among SSD and non-SSD adolescent
Time frame: During the pandemic

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giuseppe Abbracciavento, MD study chair

Institute for maternal and child health Burlo Garofolo

Laura De Nardi, MD principal investigator

Institute for maternal and child health Burlo Garofolo

Andrea Trombetta, MD principal investigator

Institute for maternal and child health Burlo Garofolo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Somatic Symptom Disorder, run by IRCCS Burlo Garofolo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.