NCT05920161

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 15, 2025

Completed
Last Updated

October 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

June 15, 2023

Results QC Date

September 26, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

memory

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (2)

  • Cortisol Reactivity

    1-2 hours

  • Alpha-amylase Reactivity

    1-2 hours

Study Arms (2)

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

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

Behavioral: Control

Interventions

The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements

Acute Stress
ControlBEHAVIORAL

This is matched to the SECPT but with warm instead of cold water

No Stress

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Spatial Learning

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Results Point of Contact

Title
Elizabeth Goldfarb, PhD
Organization
Yale School of Medicine

Study Officials

  • Elizabeth V Goldfarb, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 27, 2023

Study Start

March 2, 2023

Primary Completion

October 4, 2024

Study Completion

October 4, 2024

Last Updated

October 15, 2025

Results First Posted

October 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Aggregate data will be shared on NIMH Data Archives

Locations