Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-27 @ 12:38 AM
Study NCT ID:
NCT01390168
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2011-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-administrated Treatment of Anxiety Disorders
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2011-07-06', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)', 'timeFrame': 'Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment', 'description': 'Measures anxiety and depressive symptoms.\n\nChange from baseline in anxiety and depressive symptoms expected between time frames.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Beck Anxiety Inventory (BAI)', 'timeFrame': 'Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment', 'description': 'Measures anxiety symtoms.\n\nChange from baseline in anxiety symptoms expected between time frames.'}, {'measure': 'Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)', 'timeFrame': 'Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment', 'description': 'Measures depressive symptoms.\n\nChange from baseline in depressive symptoms expected between time frames.'}, {'measure': 'Change from baseline in Quality of Life Inventory (QOLI)', 'timeFrame': 'Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment', 'description': 'Measures quality of life.\n\nChange from baseline in quality of life expected between time frames.'}]}, 'conditionsModule': {'conditions': ['Anxiety Disorders', 'Depression']}, 'referencesModule': {'references': [{'pmid': '24933451', 'type': 'DERIVED', 'citation': 'Nordgren LB, Hedman E, Etienne J, Bodin J, Kadowaki A, Eriksson S, Lindkvist E, Andersson G, Carlbring P. Effectiveness and cost-effectiveness of individually tailored Internet-delivered cognitive behavior therapy for anxiety disorders in a primary care population: a randomized controlled trial. Behav Res Ther. 2014 Aug;59:1-11. doi: 10.1016/j.brat.2014.05.007. Epub 2014 Jun 2.'}, {'pmid': '22321916', 'type': 'DERIVED', 'citation': 'Nordgren LB, Andersson G, Kadowaki A, Carlbring P. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial. Trials. 2012 Feb 9;13:16. doi: 10.1186/1745-6215-13-16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years\n* fulfill the criteria for at least one anxiety syndrome\n\nExclusion Criteria:\n\n* ongoing psychological treatment\n* suicidal prone\n* ongoing alcohol addiction'}, 'identificationModule': {'nctId': 'NCT01390168', 'acronym': 'NOVA II', 'briefTitle': 'Internet-administrated Treatment of Anxiety Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)', 'orgStudyIdInfo': {'id': 'PC-FAS-2008-1145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tailored internet-administrated CBT', 'description': 'Behavioral: tailored internet-administrated CBT', 'interventionNames': ['Behavioral: Tailored Internet-administrated CBT-Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'waitlist', 'description': 'waitlist', 'interventionNames': ['Behavioral: Waitlist']}], 'interventions': [{'name': 'Tailored Internet-administrated CBT-Treatment', 'type': 'BEHAVIORAL', 'description': 'This intervention contains up to 6-10 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-administrated CBT']}, {'name': 'Waitlist', 'type': 'BEHAVIORAL', 'description': 'active waitlist', 'armGroupLabels': ['waitlist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 83', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Department of Behavioural Sciences and Learning, Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Per Carlbring, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Umeå University'}, {'name': 'Gerhard Andersson, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Linkoeping University'}, {'name': 'Lise Bergman Nordgren, Ph D Student', 'role': 'STUDY_CHAIR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per Carlbring, PhD', 'investigatorAffiliation': 'Umeå University'}}}}