Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 3:43 PM
Study NCT ID:
NCT02306356
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2014-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562465', 'term': 'Phobia, Specific'}, {'id': 'D001010', 'term': 'Anxiety, Separation'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-18', 'studyFirstSubmitDate': '2014-09-27', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Clinical Global Impressions - severity (CGI-S)', 'timeFrame': 'baseline, post-treatment (12 weeks), follow-up (3 months)', 'description': 'Change in CGI-s from baseline to post-treatment and follow-up'}], 'secondaryOutcomes': [{'measure': 'Children´s Global Assessment Scale (CGAS', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Spence Child Anxiety Scale C/P (SCAS-C/P)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Penn State Worry Questionnaire (PSWQ)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Separation Anxiety Index (SAI)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Fear Survey Schedule for Children - Revised (FSSC-R)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Child Sheehan Disability Scale (CSDS)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Child Depression Inventory (CDI)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Hospital Anxiety Depression Scale (HAD)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}, {'measure': 'Client Satisfaction Scale (CSS)', 'timeFrame': 'post-treatment (12 weeks)'}, {'measure': 'Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)', 'timeFrame': 'Baseline, post-treatment (12 weeks), follow-up (3 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Specific Phobia', 'Separation Anxiety', 'Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-12 years of age\n* Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia\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 3 months prior to baseline assessment\n\nExclusion Criteria:\n\n* Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia\n* Acute/severe psychiatric problems such as suicidal risk or severe depression\n* Ongoing psychological treatment for anxiety disorders\n* Ongoing child custody dispute or abuse in the family'}, 'identificationModule': {'nctId': 'NCT02306356', 'briefTitle': 'Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting', 'orgStudyIdInfo': {'id': '2014/1225-31/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Behavioral: Internet-delivered Cognitive Behavior Therapy', 'interventionNames': ['Behavioral: Internet-delivered Cognitive Behavior Therapy']}], 'interventions': [{'name': 'Internet-delivered Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83183', 'city': 'Östersund', 'state': 'Jämtland County', 'country': 'Sweden', 'facility': 'Child and Adolescent Mental Health Services Östersund', 'geoPoint': {'lat': 63.1792, 'lon': 14.63566}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'BUP Östersund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Eva Serlachius', 'investigatorAffiliation': 'Karolinska Institutet'}}}}