Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-29 @ 10:54 PM
Study NCT ID:
NCT05795803
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of COVID-19 Forced Isolation Context on Adolescents With and Without Somatic Symptom Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in mean PhQ15 scale scores between T0 and T1 in the SSD adolescents group.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': 'To SSD group, the Health Questionnaire Physical Symptoms (PhQ15) will be administrated to quantify the somatic symptom burden.'}], 'secondaryOutcomes': [{'measure': 'Difference in mean MASC2 scores between T0 and T1 in the SSD group.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': "SSD adolescents will receive the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items, to quantify adolescents' anxiety."}, {'measure': 'Difference in mean CDI-2 short questionnaire scores between T0 and T1 in the SSD group.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': "SSD adolescents will receive the Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items, to quantify adolescents' depression."}, {'measure': 'Difference in mean MASC2 scores between T0 and T1 in the adolescents group without SSD diagnosis.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': "Adolescents without SSD will receive the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items, to quantify adolescents' anxiety"}, {'measure': 'Difference in mean CDI-2 short questionnaires scores between T0 and T1 in the adolescents group without SSD diagnosis.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': "Adolescents without SSD will receive the Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items, to quantify adolescents' depression"}, {'measure': 'Comparison between the two groups of adolescents in the mean T1-T0 differences for MASC2 scores.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': 'Differences in the Multidimensional Anxiety Scale for Children (MASC 2), composed by 50 items'}, {'measure': 'Comparison between the two groups of adolescents in the mean T1-T0 differences for CDI-2 short questionnaires scores.', 'timeFrame': 'During the pandemic and within 6 months after the end', 'description': "Differences in Children's Depression Inventory (CDI-2) self-report short questionnaire, composed by 12 items"}, {'measure': "Description of adolescents' coping strategies during a pandemic isolation context among SSD and non-SSD adolescent", 'timeFrame': 'During the pandemic', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SSD', 'adolescents', 'coping strategies', 'social media'], 'conditions': ['Somatic Symptom Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nSecondary objectives of the study are:\n\n* 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.\n* 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.\n* To compare the difference in anxiety and depression scores time modification between the two groups of adolescents.\n* 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* SSD group: Adolescents who received a diagnosis of SSD at the Institute for maternal and child health "Burlo Garofolo"\n* 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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.\n* Adolescents experiencing a quarantine period during the Covid19 pandemic.\n\nExclusion Criteria:\n\n* Adolescents with cognitive impairment.\n* Adolescents with chronic diseases.\n* Adolescents with other neuropsychiatric disorders according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM V).\n* For the group without SSD diagnosis, any access to Emergency Department for unexplained chronic pain or any history of other psychiatric comorbidities.'}, 'identificationModule': {'nctId': 'NCT05795803', 'briefTitle': 'Effects of COVID-19 Forced Isolation Context on Adolescents With and Without Somatic Symptom Disorder', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Effects of a Pandemic Forced Isolation Context on Adolescents With Somatic Symptom Disorder. A Panel Study', 'orgStudyIdInfo': {'id': 'RC 11/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SSD group', 'description': 'Adolescents with SSD diagnosis made within previously six months or before unless assessed and confirmed by a specialist within the last six months', 'interventionNames': ['Other: Forced isolation context']}, {'label': 'Without SSD group', 'description': 'Control group: adolescents without diagnosis of SSD, matched with the SSD group by age and sex', 'interventionNames': ['Other: Forced isolation context']}], 'interventions': [{'name': 'Forced isolation context', 'type': 'OTHER', 'otherNames': ['COVID-19 lockdown'], 'description': 'Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures', 'armGroupLabels': ['SSD group', 'Without SSD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34137', 'city': 'Trieste', 'country': 'Italy', 'facility': 'Institute for Maternal and Child Health - IRCCS Burlo Garofolo-', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'overallOfficials': [{'name': 'Giuseppe Abbracciavento, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute for maternal and child health Burlo Garofolo'}, {'name': 'Laura De Nardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for maternal and child health Burlo Garofolo'}, {'name': 'Andrea Trombetta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for maternal and child health Burlo Garofolo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}