Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-04 @ 3:57 AM
Study NCT ID:
NCT06349993
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Intervention for Depression and Anxiety in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale', 'timeFrame': 'baseline and immediately after 8-week intervention', 'description': 'Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.'}, {'measure': 'Hamilton Anxiety Rating Scale', 'timeFrame': 'baseline and immediately after 8-week intervention', 'description': 'Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms.'}], 'secondaryOutcomes': [{'measure': 'ADHD(attention deficit hyperactivity disorder) Rating Scale-IV', 'timeFrame': 'baseline and immediately after 8-week intervention', 'description': 'Score Range: 0 (best outcome) to 54 (worst outcome) Higher scores indicate more severe ADHD symptoms.'}, {'measure': 'PHQ-9 (Patient Health Questionnaire-9)', 'timeFrame': 'baseline and weekly assessments during the treatment period, assessed up to 8 weeks', 'description': 'PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms.'}, {'measure': 'GAD-7 (Generalized Anxiety Disorder-7)', 'timeFrame': 'baseline and weekly assessments during the treatment period, assessed up to 8 weeks', 'description': 'GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.\n\nParticipants will be asked to engage with the digital intervention platform for a period of two months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).\n* having a HAMD(Hamilton Depression scale) score upon enrollment\n* demonstrate normal cognitive function.\n* voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.\n\nExclusion Criteria:\n\n* with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning\n* with concurrent psychiatric disorders (as determined by clinical assessment)\n* with concurrent psychiatric disorders (as determined by the assessing clinician)\n* at high risk of suicide"}, 'identificationModule': {'nctId': 'NCT06349993', 'briefTitle': 'Digital Intervention for Depression and Anxiety in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Adai Technology (Beijing) Co., Ltd.'}, 'officialTitle': 'Digital Intervention for Depression and Anxiety in Adolescents', 'orgStudyIdInfo': {'id': 'pd003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Intervention', 'interventionNames': ['Behavioral: Digital Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education', 'interventionNames': ['Behavioral: Health Education']}], 'interventions': [{'name': 'Digital Intervention', 'type': 'BEHAVIORAL', 'description': 'game-based digital intervention app', 'armGroupLabels': ['Digital Intervention']}, {'name': 'Health Education', 'type': 'BEHAVIORAL', 'description': 'traditional health education app', 'armGroupLabels': ['Health Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liqun Zhang', 'role': 'CONTACT'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Liqun Zhang', 'role': 'CONTACT', 'email': 'zhangliqun@adai-tech.com', 'phone': '010-85795371'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adai Technology (Beijing) Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}