Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-05 @ 8:20 AM
Study NCT ID:
NCT02350257
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2015-01-25', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Severity Rating (CSR)', 'timeFrame': 'Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended', 'description': 'Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Presence of DSM Anxiety disorder', 'timeFrame': 'Assessed at Pre, Post, 3-month and 12-month Follow-up'}, {'measure': 'Children´s Globas Assessment Scale (CGAS)', 'timeFrame': 'Assessed at Pre, Post, 3-month and 12-month Follow-up'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I)', 'timeFrame': 'Assessed at Post, 3-month and 12-month Follow-up'}, {'measure': 'Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)', 'timeFrame': 'Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up'}, {'measure': 'Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)', 'timeFrame': 'Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up'}, {'measure': 'KIDSCREEN-10 Child version', 'timeFrame': 'Assessed at Pre, Post, 3-month and 12-month Follow-up', 'description': 'Quality of life'}, {'measure': 'KIDSCREEN-10 Parent version', 'timeFrame': 'Assessed at Pre, Post, 3-month and 12-month Follow-up', 'description': 'Quality of life'}, {'measure': 'Education, Work and Social Adjustment Scale - Child version (EWSAS-C)', 'timeFrame': 'Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up'}, {'measure': 'Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)', 'timeFrame': 'Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up'}, {'measure': 'Hospital Anxiety and Depression Scale - Parents (HADS)', 'timeFrame': 'Assessed at Pre'}, {'measure': 'Technology Acceptance Scale - Child (TAS-C)', 'timeFrame': 'Assessed at Mid-3 weeks and Post', 'description': 'Perceived usefulness and perceived ease of use'}, {'measure': 'Technology Acceptance Scale - Parent (TAS-P)', 'timeFrame': 'Assessed at Mid-3 weeks and Post', 'description': 'Perceived usefulness and perceived ease of use'}, {'measure': 'Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)', 'timeFrame': 'Assessed at Pre, Post, 3-month and 12-month Follow-up'}, {'measure': 'Measurement of compliance to exposure assignments and anxiety levels, through mobile app', 'timeFrame': 'During the 12 weeks of ICBT', 'description': 'Participants register anxiety levels in adjunction to exposure exercises, with a smartphone app'}, {'measure': 'Unintended treatment effects', 'timeFrame': 'Assessed at Post'}, {'measure': 'Specific Phobia Questionnaire - Child version (SPQ-C)', 'timeFrame': 'Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up'}, {'measure': 'Specific Phobia Questionnaire - Parent version (SPQ-P)', 'timeFrame': 'Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive behavior therapy', 'child', 'randomized controlled trial', 'internet'], 'conditions': ['Anxiety Disorders']}, 'referencesModule': {'references': [{'pmid': '30241993', 'type': 'DERIVED', 'citation': 'Jolstedt M, Wahlund T, Lenhard F, Ljotsson B, Mataix-Cols D, Nord M, Ost LG, Hogstrom J, Serlachius E, Vigerland S. Efficacy and cost-effectiveness of therapist-guided internet cognitive behavioural therapy for paediatric anxiety disorders: a single-centre, single-blind, randomised controlled trial. Lancet Child Adolesc Health. 2018 Nov;2(11):792-801. doi: 10.1016/S2352-4642(18)30275-X. Epub 2018 Sep 18.'}], 'seeAlsoLinks': [{'url': 'http://www.bup.se/bip', 'label': 'Barninternetprojektet'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia)\n* Age between 8 and 12 years\n* Ability to read and write Swedish\n* Daily access to the internet\n* A parent that is able to co-participate in the treatment\n* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment\n\nExclusion Criteria:\n\n* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder\n* Present risk of suicide\n* Ongoing substance dependence\n* Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)'}, 'identificationModule': {'nctId': 'NCT02350257', 'briefTitle': 'Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings', 'orgStudyIdInfo': {'id': 'BIPSY RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICBT', 'description': 'Internet-based cognitive behavior therapy', 'interventionNames': ['Behavioral: Internet-based CBT']}, {'type': 'NO_INTERVENTION', 'label': 'Supportive control', 'description': 'Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety.'}], 'interventions': [{'name': 'Internet-based CBT', 'type': 'BEHAVIORAL', 'description': '12 weeks of internet-based CBT', 'armGroupLabels': ['ICBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 30', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'BUP CPF', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, child psychiatrist, MD', 'investigatorFullName': 'Eva Serlachius', 'investigatorAffiliation': 'Karolinska Institutet'}}}}