Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-07 @ 1:08 PM
Study NCT ID:
NCT05920161
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influence of Stress on Encoding and Prediction
Sponsor:
Organization:
Raw JSON
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Data presented here is the proportion of studied items attributed to the correct condition (A, B or X) minus the proportion of nonstudied items incorrectly attributed to that same condition."}], 'secondaryOutcomes': [{'measure': 'Cortisol Reactivity', 'timeFrame': '1-2 hours', 'description': 'Change in salivary cortisol levels following the SECPT/control procedure'}, {'measure': 'Alpha-amylase Reactivity', 'timeFrame': '1-2 hours', 'description': 'Change in salivary alpha-amylase levels following the SECPT/control procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['memory'], 'conditions': ['Stress', 'Learning, Spatial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.', 'detailedDescription': 'This study aims to assess the neural and behavioral mechanisms by which acute stress modulates episodic encoding (which involves the trisynaptic pathway: entorhinal cortex, dentate gyrus, cornu ammonis \\[CA\\] 3, and CA 1) and statistical learning (monosynaptic pathway: entorhinal cortex, CA1) in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years old\n* Fluent in English\n* BMI 18-35\n\nExclusion Criteria:\n\n* Meeting current DSM-V criteria for any substance use disorder (except caffeine)\n* Having current significant medical conditions or psychiatric symptoms requiring medication\n* Current use of medications/drugs that interfere with physiological stress responses\n* Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies\n* Metal in body (for MRI safety) history will be assessed for female participants.'}, 'identificationModule': {'nctId': 'NCT05920161', 'briefTitle': 'Influence of Stress on Encoding and Prediction', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Neural Mechanisms of Stress Effects Across Hippocampal Encoding and Prediction', 'orgStudyIdInfo': {'id': '2000030825'}, 'secondaryIdInfos': [{'id': '1R21MH128740-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH128740-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Stress', 'description': 'Participants complete the socially evaluated cold pressor test (SECPT), a validated laboratory-based stress induction procedure involving submerging an arm in an ice bath', 'interventionNames': ['Behavioral: Socially Evaluated Cold Pressor Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Stress', 'description': 'Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Socially Evaluated Cold Pressor Test', 'type': 'BEHAVIORAL', 'description': 'The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements', 'armGroupLabels': ['Acute Stress']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'This is matched to the SECPT but with warm instead of cold water', 'armGroupLabels': ['No Stress']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Elizabeth V Goldfarb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate data will be shared on NIMH Data Archives'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}