Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT05860660
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screens, Virtual Reality and Digital Addiction (EVADD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082424', 'term': 'Internet Addiction Disorder'}], 'ancestors': [{'id': 'D000088942', 'term': 'Technology Addiction'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of participants with addictive behaviour', 'timeFrame': '6 months', 'description': 'Percentage (%) of participants with more than 5 positive answers (YES) in the Smartphone Questionnaire containing 15 questions which suggests addictive behaviour'}], 'secondaryOutcomes': [{'measure': 'percentage of participants using video games', 'timeFrame': '6 months', 'description': 'Percentage (%) of participants who answered YES to the use of video games and analysis of the "Gaming Disorder-20 items" questionnaire from a scale of 1 (strongly disagree) to 5 (strongly agree)'}, {'measure': 'Percentage of participants using online gambling', 'timeFrame': '6 months', 'description': 'Percentage (%) of participants who answered YES to the use online gambling and and analysis of the "online gambling - 9 items" questionnaire on a scale of 0 to 3 (0: Never, 1: Sometimes, 2: Most of the time, 3'}, {'measure': 'Percentage of participants using social media networks', 'timeFrame': '6 months', 'description': 'Percentage (%) of participants who answered YES to the various questions on social networks , and analysis of the questionnaire "time spent on social media networks"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone', 'Social Media'], 'conditions': ['Internet Addiction Disorder']}, 'descriptionModule': {'briefSummary': 'This is an observational study questionnaire-based. This study will be carried out to evaluate the methods of consumption (work/outside work), the characteristics of the tools used, the addictive risk, the consequences on mental and physical health and the impact on quality of life of people exposed to screens and smartphones.\n\nA sample of 800 000 people will be used to learn about the entire French population. Participants will be asked to respond to an anonymous digital survey.\n\nThe ultimate goal of this work is to have quality information to help facilitate therapeutic efforts in support of those who may need it.', 'detailedDescription': 'Inappropriate use of the smartphone is defined as excessive use of the technological tool interfering with social and/or professional activities causing negative consequences such as the alteration of certain cognitive functions such as attention. In addition, the excessive use of smartphones has generated a new form of digital symptoms such as NOMO or nomophobia (addiction to mobile phones by compulsive checking of new messages or social networks) and FOMO (fear of being excluded enriching social experiences, Fear of Missing Out).\n\nFrom the perspective of social media addiction, research has shown that there is a fine line between habitual, frequent, unproblematic use and problematic and possibly addictive use of social media. Users who express symptoms and consequences traditionally associated with substance addiction (salience, mood changes, tolerance phenomenon, craving, withdrawal, relapse) could be addicted to social media.\n\nNowadays, abstinence from digital media and consumption cannot realistically be achieved in the context of SR addiction, as the internet and social media have become essential parts of our lives. Rather than shutting down social media altogether, therapy should focus on establishing controlled social media use and digital media awareness.\n\nThis study will be carried out to evaluate the methods of consumption (work/outside work), the characteristics of the tools used, the addictive risk, the consequences on mental and physical health and the impact on quality of life of people exposed to screens and smartphones.\n\nA sample of 800 000 people will be used to learn about the entire French population. Participants will be asked to respond to an anonymous digital survey.\n\nThis is an observational study questionnaire-based. The ultimate goal of this work is not to overpathologize daily behaviours, but to have quality information to help facilitate therapeutic efforts in support of those who may need it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'French population, adults, liste of members of the PRO-BTP insurance, volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older (adult)\n* members of the PRO-BTP insurance (email list)\n* understanding French language\n\nExclusion Criteria:\n\n* less than 18 years old'}, 'identificationModule': {'nctId': 'NCT05860660', 'acronym': 'EVADD', 'briefTitle': 'Screens, Virtual Reality and Digital Addiction (EVADD)', 'organization': {'class': 'OTHER', 'fullName': 'Institut Rafael'}, 'officialTitle': 'Assessment of Screen Use and Impact of Excessive Smartphone Use on Adult Health', 'orgStudyIdInfo': {'id': 'IR-2023/0001'}, 'secondaryIdInfos': [{'id': '2023-A00312-43', 'type': 'OTHER', 'domain': 'National Agency for the Safety of Medicines and Health Products (ANSM, France)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'BEHAVIORAL', 'description': 'questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92300', 'city': 'Levallois-Perret', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Institut Rafael', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Rafael', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}