Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-26 @ 5:01 PM
Study NCT ID:
NCT04907903
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-02', 'size': 652649, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-07T16:18', 'hasProtocol': True}, {'date': '2022-02-02', 'size': 427300, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-07T16:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome Questionnaire (OQ-45)', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It measures the changes in adult patients thanks to intervention.'}], 'secondaryOutcomes': [{'measure': 'Perceived stress scale (PSS)', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It evaluates the perceived stress by person'}, {'measure': 'Emotional regulation questionnaire (ERQ)', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It measures how respondents regulate their emotions through two dimensions: cognitive revaluation and expressive suppression.'}, {'measure': 'Depression Anxiety Stress Scales-Short Version (DASS-21)', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It allows to observe three dimensions (depression, anxiety and stress)'}, {'measure': 'Fear of COVID-19 Scale (FCV-19S)', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It evaluates how subjects show fear relative to the recent pandemic of Coronavirus'}, {'measure': 'General Self-efficacy Scale (GSES)', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It evaluates the confidence of subjects in their ability to cope with a variety of difficult or stressing situations.'}, {'measure': 'World Health Organization Quality of Life (WHOQOL)-BREF', 'timeFrame': 'Baseline, 2 months follow-up, 12 months follow-up', 'description': 'It detects four dimensions of quality of life: physical health, psychological health, social relations and environment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'internet-based intervention', 'cognitive-behavioral therapy'], 'conditions': ['Psychological Disease']}, 'descriptionModule': {'briefSummary': 'This study aims is the evaluation of the efficacy and feasibility of RinasciMENTE, the Randomized Controlled Clinical Trial compared with a waiting list control group.', 'detailedDescription': 'A sample of 128 participants, who experience psychological discomfort due to COVID-19, will be recruited. After initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. Measures will be taken at the baseline (T0), at the end of the treatment (T1) and 12 months follow-up (T2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or over and both gender\n* Italian mother-tongue\n* Score 14 or less on Patients Health Questionnaire-9 (PHQ-9)\n* Internet access and basic informatic ability to navigate the internet platform\n* Must be able to complete a phone interview\n\nExclusion Criteria:\n\n* Having severe and mental impairments, psychiatric condition and neurological disorder\n* Not be able to use a computer or do not have internet access\n* Not be able to complete a phone interview\n* Score 15 or more on PHQ-9'}, 'identificationModule': {'nctId': 'NCT04907903', 'briefTitle': 'RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to Coronavirus-19: Study Protocol of a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '25-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RinasciMENTE', 'description': 'Participants will receive the internet-based intervention.', 'interventionNames': ['Other: internet-based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting-list', 'description': 'Participants will no receive the internet-based intervention.'}], 'interventions': [{'name': 'internet-based intervention', 'type': 'OTHER', 'description': 'Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).', 'armGroupLabels': ['RinasciMENTE']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vanessa Bertuzzi', 'role': 'CONTACT', 'email': 'vanessa.bertuzzi@unicatt.it', 'phone': '347-4752286'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bar-Ilan University, Israel', 'class': 'OTHER'}, {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Vanessa Bertuzzi', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}