StressNCT05920161

Influence of Stress on Encoding and Prediction

A study testing Socially Evaluated Cold Pressor Test in people with Stress and Learning, Spatial, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Stress, Learning, Spatial
What is being tested?: Socially Evaluated Cold Pressor Test
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2023to 4 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18-45 years old
Fluent in English
BMI 18-35

Who cannot join

Meeting current DSM-V criteria for any substance use disorder (except caffeine)
Having current significant medical conditions or psychiatric symptoms requiring medication
Current use of medications/drugs that interfere with physiological stress responses
Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
Metal in body (for MRI safety) history will be assessed for female participants.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Neural Mechanisms of Stress Effects Across Hippocampal Encoding and Prediction

The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.

Read the detailed description

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.

Conditions: Stress, Learning, Spatial
Being tested: Socially Evaluated Cold Pressor Test, Control
Keywords: memory
Medical subject headings: Spatial Learning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Socially Evaluated Cold Pressor TestBehavioural
The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements
ControlBehavioural
This is matched to the SECPT but with warm instead of cold water

Study groups in NCT05920161
Study group	Role	What they receive
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 Receives: Behavioral: Socially Evaluated Cold Pressor Test
No Stress	Active comparator	Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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%)
Measured: 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.
Measured: 1 hour

Secondary outcomes (2)

Cortisol Reactivity
Change in salivary cortisol levels following the SECPT/control procedure
Measured: 1-2 hours
Alpha-amylase Reactivity
Change in salivary alpha-amylase levels following the SECPT/control procedure
Measured: 1-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20234 Oct 2024

First posted27 Jun 2023
Study start2 Mar 2023
Primary completion4 Oct 2024
Study completion4 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StressStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05920161
Sponsor's protocol ID: 2000030825
Other IDs: 1R21MH128740-01A1
Status last verified: Sep 2025
First submitted: 15 Jun 2023
Last updated: 15 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Aggregate data will be shared on NIMH Data Archives

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neural Mechanisms of Stress Effects Across Hippocampal Encoding and Prediction
ClinicalTrials.gov ID: NCT05920161
Acronym / sponsor ID: 2000030825
Conditions: Stress, Learning, Spatial
Keywords: memory
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 2 Mar 2023 (actual)
Primary completion: 4 Oct 2024 (actual)
Study completion: 4 Oct 2024 (actual)
First posted: 27 Jun 2023 (actual)
Results: Posted 15 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acute Stress	Experimental	Behavioral: Socially Evaluated Cold Pressor TestParticipants 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	Behavioral: ControlParticipants complete a matched condition with no stress-related exposure involving submerging an arm in warm water

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

18-45 years old
Fluent in English
BMI 18-35

Key exclusion criteria (5 listed)

Meeting current DSM-V criteria for any substance use disorder (except caffeine)
Having current significant medical conditions or psychiatric symptoms requiring medication
Current use of medications/drugs that interfere with physiological stress responses
Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
Metal in body (for MRI safety) history will be assessed for female participants.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Socially Evaluated Cold Pressor TestThe SECPT is a brief validated laboratory-based stress induction containing both physical and social elements	Behavioural	Acute Stress
ControlThis is matched to the SECPT but with warm instead of cold water	Behavioural	No Stress

Primary outcome

Changes in fMRI Signal
Time frame: 1-2 hours
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.
Statistical Learning
Time frame: 1-2 hours
Online measures of statistical learning ( mean reaction time) based on item predictability during task for condition A, B or x.
Retention of Statistical Learning
Time frame: 1 hour
Offline measure of statistical learning assessed through familiarity tests the next day (comparison of accurate recognition of previously-studied pairs to chance, 50%)
Episodic Memory
Time frame: 1 hour
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.

2 secondary outcomes

Cortisol Reactivity
Time frame: 1-2 hours
Alpha-amylase Reactivity
Time frame: 1-2 hours

Results and safety

Results posted to the registry on 15 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Stress	50	50
No Stress	47	47

Primary outcome: Changes in fMRI Signal

Time frame: 1-2 hours. Number. Unit: Pearson's rho

Measure	Acute Stress n = 45	No Stress n = 43
Value	0.261	-0.264

Acute Stress: p = 0.023, t-test, 1 sided
No Stress: p = 0.068, t-test, 1 sided

Primary outcome: Statistical Learning

Time frame: 1-2 hours. Mean (Standard Deviation). Unit: minutes

Measure	Acute Stress n = 49	No Stress n = 47
A condition	0.692 (0.092)	0.698 (0.078)
B condition	0.694 (0.094)	0.694 (0.074)
X condition	0.686 (0.087)	0.693 (0.070)

Acute Stress: p = 0.281, t-test, 1 sided
No Stress: p = 0.645, t-test, 1 sided
Acute Stress vs No Stress: p = 0.245, t-test, 2 sided

Primary outcome: Retention of Statistical Learning

Time frame: 1 hour. Mean (Standard Deviation). Unit: correct pairs

Measure	Acute Stress n = 49	No Stress n = 47
Value	0.537 (0.247)	0.477 (0.188)

Acute Stress: p = 0.143, t-test, 1 sided
No Stress: p = 0.797, t-test, 1 sided
Acute Stress vs No Stress: p = 0.087, t-test, 2 sided

Primary outcome: Episodic Memory

Time frame: 1 hour. Mean (Standard Deviation). Unit: proportion of items

Measure	Acute Stress n = 49	No Stress n = 47
A condition	0.067 (0.076)	0.639 (0.072)
B condition	0.590 (0.079)	0.619 (0.094)
X condition	0.615 (0.071)	0.611 (0.073)

Acute Stress vs No Stress: p <0.0001, t-test, 2 sided
Acute Stress vs No Stress: p <0.0001, t-test, 2 sided
Acute Stress vs No Stress: p <0.0001, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Stress	0 of 50 (0%)	0 of 50 (0%)	0 of 50
No Stress	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Aggregate data will be shared on NIMH Data Archives

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth V Goldfarb, PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Socially Evaluated Cold Pressor Test in people with Stress and Learning, Spatial, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in fMRI Signal (time frame: 1-2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05920161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.