Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-26 @ 9:04 PM
Study NCT ID:
NCT01145261
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2010-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of anxiety - by cgi and scared scales', 'timeFrame': '16 weeks'}]}, 'conditionsModule': {'keywords': ['Anxiety,', 'Emotional Regulation'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'The current study will focus on two phases of anxiety process: Generating Anxiety (reported, direct and physiological) and Emotional Regulation Strategies (Reappraisal, Mindfulness, Expressive Suppression and Rumination). The claim is that better understanding of these phases in relation to CBT treatment will lead to better understanding of remission in anxiety and to better treatments in the future. Objectives: To understand the relations between the four strategies of emotional regulation to anxiety disorder hence to understand the relation between these strategies to treatment effectiveness of children with anxiety disorder. Methods: In phase one, clinically anxious adolescence before treatment (N=40) and healthy controls (N=40) will be compared. Anxious adolescence are expected to have significantly higher levels of physical arousal and will use spontaneously more expressive suppression and rumination and less reappraisal and mindfulness then the healthy controls. In phase two, clinically anxious adolescence (N=40) before and after 8-12 weeks of CBT treatment will be compared. More specifically remitted patients will be compared with partially remitted patients. Remitted patients are expected to show better improvement in the physical arousal, then partially remitted. More, Decrease in levels of anxiety will be mediated by the four emotional regulation strategies, and the efficiency of using the Reappraisal will be higher.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The anxious group: children who will present to the Anxiety Disorder Outpatient Clinic at Schneider Children's Hospital in Israel.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anxious group: Clinical diagnosis of one or more of the following diagnoses: Generalized Anxiety Disorder, Social Anxiety, Separation Anxiety, panic disorder.\n* non anxious group: do not meet the criteria for anxiety disorders as well as for any other mental disorder\n\nExclusion Criteria:\n\n* anxious group: not treated during the study in any other treatment for anxiety disorders.Clinical diagnosis of one or more of the following diagnoses: psychosis, dyslexia, mental retardation, PTSD.'}, 'identificationModule': {'nctId': 'NCT01145261', 'briefTitle': 'The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study', 'orgStudyIdInfo': {'id': '5846'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anxiety', 'description': 'Children with anxiety disorders'}, {'label': 'healthy controls', 'description': 'children without anxiety disorders'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'state': 'Israel', 'country': 'Israel', 'facility': "Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Alan Apter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Director Department of Psychological Medicine Schneider Children's Medical Center of Israel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director Department of Psychological Medicine Schneider Children's Medical Center of Israel", 'investigatorFullName': 'alan apter', 'investigatorAffiliation': 'Rabin Medical Center'}}}}