Influence of Stress on Encoding and Prediction

• Sponsor: Yale University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05920161
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stress; Learning, Spatial	Behavioral: Socially Evaluated Cold Pressor Test; Behavioral: Control	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Neural Mechanisms of Stress Effects Across Hippocampal Encoding and Prediction
• Actual Study Start Date: Mar 2, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: Socially Evaluated Cold Pressor Test; The SECPT is a brief validated laboratory-based stress induction containing both physical and social elements
Active Comparator: No Stress Participants complete a matched condition with no stress-related exposure involving submerging an arm in warm water	Behavioral: Control; This is matched to the SECPT but with warm instead of cold water

Outcome Measures

Primary Outcome Measures

1. Changes in fMRI signal [1-2 hours]

   fMRI signal during learning will be assessed using connectivity, multivariate, and univariate approaches over 1-2 hour long learning period

2. Statistical learning [1-2 hours]

   Online measures of statistical learning (reaction time) based on item predictability during task

3. Retention of statistical learning [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%)

4. Episodic memory [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)

Secondary Outcome Measures

1. Cortisol reactivity [1-2 hours]

   Change in salivary cortisol levels following the SECPT/control procedure

2. Alpha-amylase reactivity [1-2 hours]

   Change in salivary alpha-amylase levels following the SECPT/control procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18-45 years old

• Fluent in English

• BMI 18-35

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Yale University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Elizabeth V Goldfarb, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT05920161
• Other Study ID Numbers: 2000030825; 1R21MH128740-01A1
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 28, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yale University: memory

Study Results

No Results Posted as of Jun 28, 2023