Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-04-17 @ 3:00 PM
Study NCT ID:
NCT01402258
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2011-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-administrated Treatment of Anxiety Symptoms for Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Anxiety Inventory (BAI)- Change from baseline', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment', 'description': 'Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Inventory (QOLI)- Change from baseline', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment', 'description': 'Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.'}, {'measure': 'Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)- Change from baseline', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment', 'description': 'Change from baseline in depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.'}, {'measure': 'Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)- Change from baseline', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment', 'description': 'Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety Disorders', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between the ages of 16-25 years old\n* Have anxiety symptoms and/or anxiety syndrome\n\nExclusion Criteria:\n\n* Suicide prone\n* Alcohol addiction\n* Ongoing psychological treatment'}, 'identificationModule': {'nctId': 'NCT01402258', 'acronym': 'NOVA-IV', 'briefTitle': 'Internet-administrated Treatment of Anxiety Symptoms for Young Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults', 'orgStudyIdInfo': {'id': 'GA-FORSS-2011-150291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Internet-delivered CBT', 'description': 'Behavioral: Tailored Internet-delivered CBT', 'interventionNames': ['Behavioral: Tailored Internet-administrated CBT-Treatment']}], 'interventions': [{'name': 'Tailored Internet-administrated CBT-Treatment', 'type': 'BEHAVIORAL', 'description': 'This intervention contains 6-8 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.', 'armGroupLabels': ['Tailored Internet-delivered CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58183', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Department of Behavioral Sciences and Learning, Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Gerhard Andersson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Behavioral Sciences and Learning, Linköping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}