Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00482820
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2007-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Research Studying a Method of Intervention for Children Diagnosed With Anxiety Disorder: Attentional Bias Intervention
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2007-06-04', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety questionnaire - that are specified in the protocol. mood scale- as described in the protocol attention bias scores- as described in the protocol', 'timeFrame': '2-4 weeks'}]}, 'conditionsModule': {'keywords': ['anxiety', 'attention-biases', 'children'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '22423353', 'type': 'DERIVED', 'citation': 'Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.'}]}, 'descriptionModule': {'briefSummary': 'Studies show that children with high levels of anxiety tend to pay more attention to threatening stimulus in the environment. They tend to attend to these stimuli and have difficulty to disengage from them. These attention biases enhance and maintain the level of anxiety. The aim of this study is to test a method of therapeutically intervention which focuses on shifting these attentional biases, with the use of a computer game which was designed to train the child to focus his/her attention away from the threatening stimuli and to focus on natural or positive stimuli. We will recruit 160 children with ongoing anxiety disorders who seek treatment. We will first assess threat-related attention bias and anxiety symptoms using structured psychiatric interviews and questionnaires. We will then randomly assign these children to one of four conditions: training to avoid threatening stimuli and attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for positive-neutral stimuli. Upon completion of training we will again assess attention bias and anxiety.\n\nTwo sets of predictions will be tested, one set concerns the effects of training on attention, and the other concerns the effects of training on anxiety. In terms of training effects on attention, we hypothesize that children with anxiety disorders can be trained to either avoid threat or attend to positive stimuli. In terms of training effects on anxiety symptoms, we hypothesize that the experimental training sessions will produce greater reduction in symptoms of anxiety than the placebo-control training sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with Clinical diagnosis of Generalized Anxiety Disorder (GAD), Social Phobia (SP), or Separation Anxiety Disorder (SAD).\n\nExclusion Criteria:\n\n* Children with the diagnoses of OCD, specific phobia, and PTSD in the absence of comorbid GAD, SP, or SAD.\n* Other exclusion criteria include ongoing major depressive disorder, and use of psychotropic medication.'}, 'identificationModule': {'nctId': 'NCT00482820', 'briefTitle': 'A Clinical Research Studying a Method of Intervention for Children Diagnosed With Anxiety Disorder: Attentional Bias Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'orgStudyIdInfo': {'id': '4373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'attention training away from threat', 'interventionNames': ['Behavioral: attention-bias training']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo attention training', 'interventionNames': ['Behavioral: attention-bias training']}], 'interventions': [{'name': 'attention-bias training', 'type': 'BEHAVIORAL', 'description': 'one group recive an attention training away from threat. The second group, the controll group, recive a placebo training', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bar-Haim Yair, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': "Tel-aviv university; and schnider children's medical center of isreal"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel", 'investigatorFullName': 'alan apter', 'investigatorAffiliation': 'Rabin Medical Center'}}}}