Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02945735
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gaze Contingent Feedback in Major Depressive Disorder (MDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis', 'timeFrame': 'approximately 20 min', 'description': 'a structured diagnostic interview for DSM - IV and ICD-10 psychiatric disorders, which takes approximately 20 min to administer and is a valid and time-efficient alternative to the SCID-P and CIDI.'}], 'primaryOutcomes': [{'measure': 'Change from baseline - Structured Interview for the Montgomery-Asberg Depression Rating Scale (SIGMA)', 'timeFrame': 'post treatment (1 week after treatment completion) and 3-month follow up', 'description': 'The SIGMA is a ten-item diagnostic structured interview which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on scale ranging from 0 to 6 with a possible total score of 60, with regard to the passing week.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline - BDI-II - Beck Depression Inventory', 'timeFrame': 'post treatment (1 week after treatment completion) and 3-month follow up', 'description': 'The BDI -II is a 21-question multiple-choice self-report inventory. Each item is rated on scale ranging from 0 to 3, Higher total scores indicate more severe depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'cognitive bias modification', 'MDD', 'major depressive disorder', 'attention bias modification treatment'], 'conditions': ['Depression, Unipolar', 'Depressive Disorder', 'Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)', 'detailedDescription': 'The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A signed consent form\n* Men and women between the ages of 18 and 65.\n* Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV\n* MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders\n* Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.\n\nExclusion Criteria:\n\n* Psychotic episode in the past or the present time.\n* Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).\n* Another psychotherapeutic treatment during the study.\n* Usage of neuroleptic medication.\n* Change in medication status during the study.\n* Substantial usage of drugs or alcohol in the present time.\n* Poor judgment capacity (i.e., children under 18 and special populations).\n* High Risk of Suicide.'}, 'identificationModule': {'nctId': 'NCT02945735', 'briefTitle': 'Gaze Contingent Feedback in Major Depressive Disorder (MDD)', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Gaze Contingent Feedback in Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'TAUDEPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gaze-contingent', 'description': 'Attention modification: participants will receive gaze-contingent feedback according to their viewing patterns', 'interventionNames': ['Behavioral: Attention Modification']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-gaze contingent', 'description': 'Participants will receive non-gaze-continent feedback unrelated to their viewing patterns', 'interventionNames': ['Behavioral: Attention Modification']}], 'interventions': [{'name': 'Attention Modification', 'type': 'BEHAVIORAL', 'description': "Feedback according to participants' viewing patterns, in order to modify their attention.", 'armGroupLabels': ['gaze-contingent', 'non-gaze contingent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Yair Bar-Haim, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University', 'investigatorFullName': 'Yair Bar-Haim', 'investigatorAffiliation': 'Tel Aviv University'}}}}