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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH128740-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Stress | Experimental | Participants complete the socially evaluated cold pressor test (SECPT), a validated laboratory-based stress induction procedure involving submerging an arm in an ice bath |
|
| No Stress | Active Comparator | Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socially Evaluated Cold Pressor Test | Behavioral | The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fMRI Signal | fMRI signal during learning will be assessed using connectivity, multivariate, and univariate approaches over 1-2 hour long learning period. Correlation between change in CA1-EC background connectivity and pair familiarity. rho represents the true correlation within the entire population, with values ranging from -1 to +1; values closer to +1 indicate a strong positive linear relationship, closer to -1 a strong negative one, and closer to 0 indicate no linear relationship. | 1-2 hours |
| Statistical Learning | Online measures of statistical learning ( mean reaction time) based on item predictability during task for condition A, B or x. | 1-2 hours |
| Retention of Statistical Learning | Offline measure of statistical learning assessed through familiarity tests the next day (comparison of accurate recognition of previously-studied pairs to chance, 50%) | 1 hour |
| Episodic Memory | Memory for individual items will be assessed through performance on old/new recognition tests the next day, quantified as hit rates and A' (non-parametric normalized ratio of hits to false alarms). 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. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol Reactivity | Change in salivary cortisol levels following the SECPT/control procedure | 1-2 hours |
| Alpha-amylase Reactivity | Change in salivary alpha-amylase levels following the SECPT/control procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth V Goldfarb, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
Aggregate data will be shared on NIMH Data Archives
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106 participants were randomized, 9 participants withdrew prior to receiving any intervention therefore 97 started
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Stress | Participants complete the socially evaluated cold pressor test (SECPT), a validated laboratory-based stress induction procedure involving submerging an arm in an ice bath Socially Evaluated Cold Pressor Test: The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements |
| FG001 | No Stress | Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water Control: This is matched to the SECPT but with warm instead of cold water |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Stress | Participants complete the socially evaluated cold pressor test (SECPT), a validated laboratory-based stress induction procedure involving submerging an arm in an ice bath Socially Evaluated Cold Pressor Test: The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in fMRI Signal | fMRI signal during learning will be assessed using connectivity, multivariate, and univariate approaches over 1-2 hour long learning period. Correlation between change in CA1-EC background connectivity and pair familiarity. rho represents the true correlation within the entire population, with values ranging from -1 to +1; values closer to +1 indicate a strong positive linear relationship, closer to -1 a strong negative one, and closer to 0 indicate no linear relationship. | Posted | Number | Pearson's rho | 1-2 hours |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Stress | Participants complete the socially evaluated cold pressor test (SECPT), a validated laboratory-based stress induction procedure involving submerging an arm in an ice bath Socially Evaluated Cold Pressor Test: The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Goldfarb, PhD | Yale School of Medicine | 203-737-6365 | elizabeth.goldfarb@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2023 | Sep 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2023 | Sep 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D065853 | Spatial Learning |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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| Control | Behavioral | This is matched to the SECPT but with warm instead of cold water |
|
| 1-2 hours |
| No Stress |
Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water Control: This is matched to the SECPT but with warm instead of cold water |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Stress | Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water Control: This is matched to the SECPT but with warm instead of cold water |
|
|
|
| Primary | Statistical Learning | Online measures of statistical learning ( mean reaction time) based on item predictability during task for condition A, B or x. | Posted | Mean | Standard Deviation | minutes | 1-2 hours |
|
|
|
|
| Primary | Retention of Statistical Learning | Offline measure of statistical learning assessed through familiarity tests the next day (comparison of accurate recognition of previously-studied pairs to chance, 50%) | Posted | Mean | Standard Deviation | correct pairs | 1 hour |
|
|
|
|
| Primary | Episodic Memory | Memory for individual items will be assessed through performance on old/new recognition tests the next day, quantified as hit rates and A' (non-parametric normalized ratio of hits to false alarms). 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. | Posted | Mean | Standard Deviation | proportion of items | 1 hour |
|
|
|
|
| Secondary | Cortisol Reactivity | Change in salivary cortisol levels following the SECPT/control procedure | Posted | Mean | Standard Deviation | log nmol/L | 1-2 hours |
|
|
|
|
| Secondary | Alpha-amylase Reactivity | Change in salivary alpha-amylase levels following the SECPT/control procedure | Posted | Mean | Standard Deviation | log nmol/L | 1-2 hours |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | No Stress | Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water Control: This is matched to the SECPT but with warm instead of cold water | 0 | 47 | 0 | 47 | 0 | 47 |
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| X condition |
|
| 0.645 |
| Superiority |
| Between-group comparison | t-test, 2 sided | 0.245 | Superiority |
| Superiority |
| t-test, 2 sided | 0.087 | Superiority |
| X condition |
|
| <0.0001 |
| Superiority |
| X condition | t-test, 2 sided | <0.0001 | Superiority |
| Superiority |
| Superiority |