Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT06724666
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2024-12-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019263', 'term': 'Dysthymic Disorder'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internalizing problems', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 months follow-up', 'description': "Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents."}], 'secondaryOutcomes': [{'measure': 'Clinical diagnosis', 'timeFrame': 'administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention', 'description': 'Change in DSM-5 Anxiety and Depressive Disorder Diagnoses in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C/P) Clinical Diagnosis'}, {'measure': 'Global functioning', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 months follow-up', 'description': "Children's Global Assessment Scale (C-GAS)"}, {'measure': 'Severity', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 months follow-up', 'description': 'Clinical Global Impression Scale - Severity'}, {'measure': 'Improvement', 'timeFrame': 'after 8 weeks of intervention, 6 months follow-up', 'description': 'Clinical Global Impression Scale - Improvement'}, {'measure': 'Comorbid problems', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 month follow-up', 'description': "Subscales of the Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents"}, {'measure': 'Life satisfaction', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 months follow-up', 'description': 'SWLS-C: Satisfaction with Life Scale for Children'}, {'measure': 'Satisfaction with the Internet-delivered intervention', 'timeFrame': 'after 8 weeks of intervention', 'description': 'Client Satisfaction Questionnaire (CSQ-8)'}, {'measure': 'Working alliance', 'timeFrame': 'after 8 weeks of intervention', 'description': 'Working alliance scale for Internet interventions'}, {'measure': 'Automatic thoughts', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 month follow-up', 'description': 'Automatic thoughts questionnaire'}, {'measure': 'Credibility and expectations', 'timeFrame': 'week 2', 'description': 'Credibility and expectations questionnaire'}, {'measure': 'Credibility and expectations based on primary outcome measure', 'timeFrame': 'baseline', 'description': 'Credibility and expectations based on primary outcome scale'}, {'measure': 'Anxiety and depressive symptoms', 'timeFrame': 'baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up', 'description': 'PHQ4'}, {'measure': 'Avoidance', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 month follow-up', 'description': 'CAMS'}, {'measure': 'Parental distress', 'timeFrame': 'baseline', 'description': 'DASS-21'}, {'measure': 'Adolescent anxiety and depressive symptoms as reported by parents', 'timeFrame': 'baseline, after 8 weeks of intervention, 6 month follow-up', 'description': 'RCADS-47 parent report'}, {'measure': 'Parental accommodations', 'timeFrame': 'baseline', 'description': 'Family accommodation scale - parent report'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internet-delivered intervention', 'transdiagnostic', 'adolescents', 'internalizing', 'anxiety', 'depression'], 'conditions': ['Anxiety Disorders', 'Depressive Disorder', 'Social Anxiety Disorder', 'Major Depressive Disorder', 'Dysthymia', 'Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are:\n\n* What is the clinical efficacy of the Internet-delivered intervention?\n* How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.", 'detailedDescription': "To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elevated symptoms of anxiety or depression/ internalizing problems (T score\\> 60) at intake (based on Youth self-report completed by adolescents)\n* primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according to ADIS-5-C/P interview\n* age 13-17\n* able to read and understand Romanian language\n* Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset\n* Internet access\n\nExclusion Criteria:\n\n* severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)\n* any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),\n* active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month\n* currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months\n* fMRI incompatible (based on safety questionnaire)\n* Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview).\n* Current treatment with benzodiazepines'}, 'identificationModule': {'nctId': 'NCT06724666', 'acronym': 'NEURO4C', 'briefTitle': 'Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression', 'organization': {'class': 'OTHER', 'fullName': 'Babes-Bolyai University'}, 'officialTitle': 'Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression', 'orgStudyIdInfo': {'id': 'PNRR-III-C9-2022-I8-CF278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transdiagnostic Internet-delivered intervention', 'description': 'The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT).', 'interventionNames': ['Behavioral: Transdiagnostic Internet-delivered intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks.'}], 'interventions': [{'name': 'Transdiagnostic Internet-delivered intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.', 'armGroupLabels': ['Transdiagnostic Internet-delivered intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400015', 'city': 'Cluj-Napoca', 'status': 'NOT_YET_RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Costina R Poetar, Ph.D', 'role': 'CONTACT', 'email': 'costinapoetar@psychology.ro', 'phone': '+ 40743589465'}, {'name': 'Costina R Poetar, Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Babes-Bolyai University', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '400015', 'city': 'Cluj-Napoca', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Babeș-Bolyai University', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Kristoffer Mansson, PhD', 'role': 'CONTACT', 'email': 'nils.mansson@ubbcluj.ro', 'phone': '+46705803267'}], 'overallOfficials': [{'name': 'Costina Poetar, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Babeș-Bolyai University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Supporting information will be shared after the publication of the results.', 'ipdSharing': 'YES', 'description': 'Deidentified individual participant data will be will be shared after the publication of the results.', 'accessCriteria': 'Supporting information will be publicly shared in OSF.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Babes-Bolyai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Costina-Ruxandra Poetar', 'investigatorAffiliation': 'Babes-Bolyai University'}}}}