Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
Study NCT ID:
NCT04105868
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2019-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adolescent Attention to Emotion Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058765', 'term': 'Neurofeedback'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mlw114@pitt.edu', 'phone': '4123832143', 'title': 'Mary Woody, PhD Assistant Professor of Psychiatry', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was a small, single-arm pilot trial with 15 participants, which may limit generalizability. Results should be interpreted as preliminary pending replication in larger, controlled samples.'}}, 'adverseEventsModule': {'timeFrame': 'Single-session monitoring on the intervention day: from the start of baseline procedures (pre-neurofeedback) through 60 minutes after completion of the neurofeedback session; total monitoring duration ≈ 2 hours on the same day.', 'description': 'Adverse events were monitored continuously during the above window via non-systematic assessment: spontaneous participant report and study-staff observation. Participants were queried at end-of-session and again at +60 minutes prior to discharge. No adverse events were observed or reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.'}], 'classes': [{'categories': [{'measurements': [{'value': '.41', 'spread': '.18', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: No within-subject change in SSVEP competition index from baseline to post-training.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-tailed paired samples t-test comparing baseline and post-training SSVEP competition index scores', 'nonInferiorityComment': 'Within-group pre/post differences were tested using a paired t-test.'}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.', 'description': 'To measure affect-biased attention, steady-state visual evoked potentials (SSVEPs) were derived from EEG and used to index the amount of stimulus-driven attention to negative distractors relative to task-relevant stimuli. Affect-biased attention was assessed immediately before and immediately after the real-time SSVEP neurofeedback training to evaluate changes within the same session. The outcome below reflects the post-neurofeedback SSVEP competition index (Task / \\[Task + Distractor\\]). Scores above .50 indicate greater attention to the task stimulus.', 'unitOfMeasure': 'Proportion (0-1)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2025-09'}, {'type': 'SECONDARY', 'title': 'Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.80', 'spread': '5.85', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.25', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: No within-subject change in VAS Sadness scores from baseline to post-stressor.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-tailed paired samples t-test comparing baseline and post-stressor VAS sadness scores.', 'nonInferiorityComment': 'Within-group pre/post differences were tested using a paired t-test.'}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 30 minutes total: baseline sadness rating immediately before and post-stressor rating immediately after the ~30-minute laboratory stressor on the same day.', 'description': 'Participants completed a laboratory stressor following real-time SSVEP neurofeedback training to assess how well the intervention buffered sadness reactivity. State sadness was assessed immediately before and immediately after the stressor using a 100-millimeter visual analog scale (VAS) ranging from "neutral" to "very sad." Higher scores indicate greater sadness. The value reported below reflects the post-stressor rating.', 'unitOfMeasure': 'Score on 0-100 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants had missing VAS Sadness scores following the stressor.'}, {'type': 'SECONDARY', 'title': 'Anxiety Rating Following Laboratory Stressor (Immediately Post-Stressor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'spread': '4.58', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.471', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: No within-subject change in VAS Anxiety scores from baseline to post-stressor.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Two-tailed paired samples t-test comparing baseline and post-stressor VAS anxiety scores.', 'nonInferiorityComment': 'Within-group pre/post differences were tested using a paired t-test.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and following laboratory stressor (~30 minutes)', 'description': 'Participants completed a laboratory stressor following real-time SSVEP neurofeedback training to assess how well the intervention buffered sadness reactivity. State anxiety was assessed immediately before and immediately after the stressor using a 100-millimeter visual analog scale (VAS) ranging from "neutral" to "very anxious." Higher scores indicate greater anxiety. The value reported below reflects the post-stressor rating.', 'unitOfMeasure': 'Score on 0-100 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants had missing VAS anxiety ratings following the stressor.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Female adolescents aged 13-15 were recruited from the community to participate in a single-arm neurofeedback study on affect-biased attention. A total of 15 participants were enrolled.', 'preAssignmentDetails': 'All enrolled participants were assigned to the neurofeedback arm; no participants were excluded prior to assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14.67', 'spread': '.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'SSVEP competition index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '.66', 'spread': '.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Competition indices for attention to the primary task vs. negative emotional distractors were calculated as the proportion of t-transformed SSVEP amplitudes to the task stimulus relative to the sum of amplitudes to both task and distractor stimuli (Task / \\[Task + Distractor\\]). Scores range from 0-1, with values above .50 reflecting greater attention to the task stimulus.', 'unitOfMeasure': 'Proportion (0-1)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Visual Analog Score - Sadness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '12.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Participants rated their level of sadness on a Visual Analogue Scale (VAS) ranging from 0 = 'not at all' to 100 = 'extremely'. Scores reflect self-reported intensity of the emotional state at baseline.", 'unitOfMeasure': 'Score on 0-100 scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant did not complete the baseline VAS Sadness measure, so data are reported for 14 participants.'}, {'title': 'Visual Analog Score - Anxiety', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '6.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Participants rated their level of anxiety on a Visual Analogue Scale (VAS) ranging from 0 = 'not at all' to 100 = 'extremely'. Scores reflect self-reported intensity of the emotional state at baseline.", 'unitOfMeasure': 'Score on 0-100 scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant did not complete the baseline VAS Anxiety measure, so data are reported for 14 participants.'}], 'populationDescription': 'All 15 participants assigned to the neurofeedback arm were included in the baseline analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-23', 'size': 172177, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-24T11:50', 'hasProtocol': True}, {'date': '2021-12-02', 'size': 3195121, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-24T12:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2019-09-24', 'resultsFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-28', 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Affect-biased Attention Following Neurofeedback (Immediately Post-Intervention)', 'timeFrame': 'Approximately 1 hour total: baseline assessment immediately before neurofeedback and post-neurofeedback assessment immediately after the ~1 hour training session on the same day.', 'description': 'To measure affect-biased attention, steady-state visual evoked potentials (SSVEPs) were derived from EEG and used to index the amount of stimulus-driven attention to negative distractors relative to task-relevant stimuli. Affect-biased attention was assessed immediately before and immediately after the real-time SSVEP neurofeedback training to evaluate changes within the same session. The outcome below reflects the post-neurofeedback SSVEP competition index (Task / \\[Task + Distractor\\]). Scores above .50 indicate greater attention to the task stimulus.'}], 'secondaryOutcomes': [{'measure': 'Sadness Ratings Following Laboratory Stressor (Immediately Post-Stressor)', 'timeFrame': 'Approximately 30 minutes total: baseline sadness rating immediately before and post-stressor rating immediately after the ~30-minute laboratory stressor on the same day.', 'description': 'Participants completed a laboratory stressor following real-time SSVEP neurofeedback training to assess how well the intervention buffered sadness reactivity. State sadness was assessed immediately before and immediately after the stressor using a 100-millimeter visual analog scale (VAS) ranging from "neutral" to "very sad." Higher scores indicate greater sadness. The value reported below reflects the post-stressor rating.'}, {'measure': 'Anxiety Rating Following Laboratory Stressor (Immediately Post-Stressor)', 'timeFrame': 'Baseline and following laboratory stressor (~30 minutes)', 'description': 'Participants completed a laboratory stressor following real-time SSVEP neurofeedback training to assess how well the intervention buffered sadness reactivity. State anxiety was assessed immediately before and immediately after the stressor using a 100-millimeter visual analog scale (VAS) ranging from "neutral" to "very anxious." Higher scores indicate greater anxiety. The value reported below reflects the post-stressor rating.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '36085716', 'type': 'DERIVED', 'citation': 'Huang X, Mak J, Wears A, Price RB, Akcakaya M, Ostadabbas S, Woody ML. Using Neurofeedback from Steady-State Visual Evoked Potentials to Target Affect-Biased Attention in Augmented Reality. Annu Int Conf IEEE Eng Med Biol Soc. 2022 Jul;2022:2314-2318. doi: 10.1109/EMBC48229.2022.9871982.'}]}, 'descriptionModule': {'briefSummary': 'Rates of depression increase rapidly during adolescence, especially for girls, and, thus, research is needed to spur the development of novel interventions to prevent adolescent depression. This project seeks to determine if a novel visuocortical probe of affect-biased attention (i.e., steady-state visual evoked potentials derived from EEG) can 1) be used to prospectively predict depression using a multi-wave repeated measures design and 2) modify affect-biased attention and buffer subsequent mood reactivity using real time neurofeedback. This work could ultimately lead to improved identification of adolescents who are at high risk for depression and directly inform the development of mechanistic treatment targets to be used in personalized intervention prescriptions for high-risk youth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will include 90 female adolescents ages 13 years 0 months through 15 years 11 months at study entry.\n\nExclusion Criteria:\n\n1. Lifetime history of any Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 depressive disorder\n2. Lifetime history of taking antidepressants \\[e.g., selective serotonin reuptake inhibitor (SSRIs)\\]\n3. Lifetime history of a DSM 5 psychotic, bipolar, or autistic spectrum disorder.\n4. Presence of EEG contraindications (e.g., personal lifetime history of seizures or family history of hereditary epilepsy).\n5. Being pre-pubertal\n6. Lifetime history of a neurological or serious medical condition.\n7. Lifetime history of head injury or congenital neurological anomalies (based on parent report).\n8. Intelligence quotient (IQ) less than 80, as assessed using the Wechsler Abbreviated Scale of Intelligence (WASI).\n9. Uncorrected visual disturbance\n10. Being acutely suicidal or at risk for harm to self or others.'}, 'identificationModule': {'nctId': 'NCT04105868', 'briefTitle': 'Adolescent Attention to Emotion Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Visuocortical Dynamics of Affect-Biased Attention in the Development of Adolescent Depression', 'orgStudyIdInfo': {'id': 'STUDY19010063'}, 'secondaryIdInfos': [{'id': 'K23MH119225', 'link': 'https://reporter.nih.gov/quickSearch/K23MH119225', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback', 'description': 'Participants will receive feedback about their attention to negative distractors during each trial using activity from their brain waves, which will help them reduce their attention to distractors.', 'interventionNames': ['Other: Neurofeedback']}], 'interventions': [{'name': 'Neurofeedback', 'type': 'OTHER', 'description': 'Participants will receive feedback during a computerized task that is based on their own visuocortical activity evoked by attention to negative distractors and task-relevant stimuli on the computer screen.', 'armGroupLabels': ['Neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Mary Woody, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data repository/sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mary Woody', 'investigatorAffiliation': 'University of Pittsburgh'}}}}