Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-05 @ 2:09 PM
Study NCT ID:
NCT02973932
Status:
UNKNOWN
Last Update Posted:
2016-11-28
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCBT for Children and Adolescents With Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-10-08', 'releaseDate': '2021-09-13'}, {'releaseDate': '2021-11-20', 'unreleaseDate': '2021-11-22'}, {'resetDate': '2022-01-27', 'releaseDate': '2021-11-24'}, {'resetDate': '2022-04-04', 'releaseDate': '2022-01-28'}, {'resetDate': '2023-02-23', 'releaseDate': '2022-05-23'}], 'estimatedResultsFirstSubmitDate': '2021-09-13'}}, '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': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-25', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)', 'timeFrame': 'beginning of the study and end therapy (about 16 weeks)'}, {'measure': "The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)", 'timeFrame': 'beginning of the study and end therapy (about 16 weeks)'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': 'beginning of the study and end therapy (about 16 weeks)'}, {'measure': 'Child Behavior Checklist (CBCL)', 'timeFrame': 'beginning of the study and end therapy (about 16 weeks)'}, {'measure': 'Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)', 'timeFrame': 'beginning of the study and end therapy (about 16 weeks)'}, {'measure': 'Impairment by OCD symptoms', 'timeFrame': 'Every day throughout the therapy process (14 weeks)', 'description': 'assessed by App'}, {'measure': 'Extend of avoidance behavior', 'timeFrame': 'Every day throughout the therapy process (14 weeks)', 'description': 'assessed by App'}, {'measure': 'Daily mood', 'timeFrame': 'Every day throughout the therapy process (14 weeks)', 'description': 'assessed by App'}, {'measure': 'How the day was', 'timeFrame': 'Every day throughout the therapy process (14 weeks)', 'description': 'assessed by App'}, {'measure': 'How strong OCD is', 'timeFrame': 'Every week throughout the therapy process (14 weeks)', 'description': 'assessed by App'}, {'measure': 'How Every week throughout the therapy processgood e progress was with specific treatment goals', 'timeFrame': 'Every week throughout the therapy process (14 weeks)', 'description': 'assessed by App'}, {'measure': 'Anxiety ratings during exposures', 'timeFrame': 'Every week three days beginning with session 4 up to 14', 'description': 'assessed by App'}, {'measure': 'Heart rate variability', 'timeFrame': 'Every day throughout the therapy (14 weeks)', 'description': 'assessed with wristband'}, {'measure': 'Skin conductance level', 'timeFrame': 'Every day throughout the therapy (14 weeks)', 'description': 'assessed with wristband'}, {'measure': 'Body temperature', 'timeFrame': 'Every day throughout the therapy (14 weeks)', 'description': 'assessed with wristband'}, {'measure': 'Body movements', 'timeFrame': 'Every day throughout the therapy (14 weeks)', 'description': 'assessed with wristband'}]}, 'conditionsModule': {'keywords': ['cognitive-behavioral psychotherapy', 'obsessive-compulsive disorder', 'internet-based'], 'conditions': ['Psychotherapy Intervention Evaluation']}, 'descriptionModule': {'briefSummary': 'Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 7 to 17 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents (ages 7-17) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker\n* German-speaking (child \\& caretakers)\n* Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone\n\nExclusion Criteria:\n\n* IQ below 70\n* A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality that requires acute treatment, and psychosis'}, 'identificationModule': {'nctId': 'NCT02973932', 'briefTitle': 'iCBT for Children and Adolescents With Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder', 'orgStudyIdInfo': {'id': 'F.1331477'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based psychotherapy', 'interventionNames': ['Behavioral: Cognitive-bahavioral psychotherapy']}], 'interventions': [{'name': 'Cognitive-bahavioral psychotherapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Internet-based psychotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Annette Conzelmann, PhD', 'role': 'CONTACT', 'email': 'annette.conzelmann@med.uni-tuebingen.de', 'phone': '004970712987513'}], 'overallOfficials': [{'name': 'Annette Conzelmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Child and Adolescent Psychiatry University of Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Annette Conzelmann', 'investigatorFullName': 'PD Dr. Annette Conzelmann', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-09-13', 'type': 'RELEASE'}, {'date': '2021-10-08', 'type': 'RESET'}, {'date': '2021-11-20', 'type': 'RELEASE'}, {'date': '2021-11-22', 'type': 'UNRELEASE'}, {'date': '2021-11-24', 'type': 'RELEASE'}, {'date': '2022-01-27', 'type': 'RESET'}, {'date': '2022-01-28', 'type': 'RELEASE'}, {'date': '2022-04-04', 'type': 'RESET'}, {'date': '2022-05-23', 'type': 'RELEASE'}, {'date': '2023-02-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PD Dr. Annette Conzelmann, PD Dr. Annette Conzelmann, University Hospital Tuebingen'}}}}