Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02663167
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2016-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Children´s Yale Brown Compulsive Scale (CY-BOCS)', 'timeFrame': 'week 0, week 12, at 3 months follow up', 'description': 'Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended'}], 'secondaryOutcomes': [{'measure': "Children's Global Assessment Scale (C-GAS)", 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Clinical Global Impression - Severity (CGI-S)', 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I)', 'timeFrame': 'week 12, at 3 months follow up'}, {'measure': 'Obsessive-Compulsive Inventory - Child Version (OCI-CV)', 'timeFrame': 'week 0, week 12, at 3 months follow up and weekly during treatment'}, {'measure': "Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)", 'timeFrame': 'week 0, week 12, at 3 months follow up and weekly during treatment'}, {'measure': 'Family Accommodation Scale - Self Rated (FAS-SR)', 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Euroqol - Youth (EQ-5D-Y)', 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Autism Spectrum Quotient (AQ-10)', 'timeFrame': 'week 0'}, {'measure': 'Education, Work and Social Adjustment Scale - child and parent version (EWSAS)', 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Child Depression Inventory - Short version (CDI-S)', 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Mood and Feeling Questionnaire - parent version (MFQ)', 'timeFrame': 'week 0, week 12, at 3 months follow up'}, {'measure': 'Qualitative data on treatment credibility', 'timeFrame': 'week 3'}, {'measure': 'Qualitative data on treatment satisfaction', 'timeFrame': 'week 12'}, {'measure': 'Safety Monitoring Uniform Report Form (SMURF)', 'timeFrame': 'week 6, week 12'}, {'measure': 'Internet Intervention Patient Adherence Scale (iiPAS)', 'timeFrame': 'week 6, week 12'}, {'measure': 'Patient Exposure/Response prevention Adherence Scale (PEAS)', 'timeFrame': 'week 6, week 12'}]}, 'conditionsModule': {'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).', 'detailedDescription': "The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary DSM-5 diagnosis of OCD\n* Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)\n* Age between 7-11 years\n* Ability to understand Swedish\n* Daily access to the Internet\n* A parent that can co-participate in the treatment\n* Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment\n\nExclusion Criteria:\n\n* Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability\n* Suicidal ideation\n* Not able to understand the basics of the ICBT self-help material\n* Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)\n* On-going psychological treatment for OCD or another anxiety disorder"}, 'identificationModule': {'nctId': 'NCT02663167', 'briefTitle': 'Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial', 'orgStudyIdInfo': {'id': 'REPN 2015/470-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-delivered Cognitive-Behavioral Therapy', 'interventionNames': ['Behavioral: Internet-delivered Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Internet-delivered Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.', 'armGroupLabels': ['Internet-delivered Cognitive-Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11330', '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': 'MD, PhD', 'investigatorFullName': 'Eva Serlachius', 'investigatorAffiliation': 'Karolinska Institutet'}}}}