Trial Outcomes & Findings for Influence of Stress on Encoding and Prediction (NCT NCT05920161)
NCT ID: NCT05920161
Last Updated: 2025-10-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
1-2 hours
Results posted on
2025-10-15
Participant Flow
106 participants were randomized, 9 participants withdrew prior to receiving any intervention therefore 97 started
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
47
|
|
Overall Study
Analyzed for Behavior
|
49
|
47
|
|
Overall Study
Analyzed for fMRI
|
45
|
43
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Stress on Encoding and Prediction
Baseline characteristics by cohort
| Measure |
Acute Stress
n=49 Participants
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
|
No Stress
n=47 Participants
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
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
n=5 Participants
|
24 years
n=7 Participants
|
24 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
47 participants
n=7 Participants
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 hoursfMRI 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.
Outcome measures
| Measure |
Acute Stress
n=45 Participants
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
|
No Stress
n=43 Participants
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
|
|---|---|---|
|
Changes in fMRI Signal
|
0.261 Pearson's rho
|
-0.264 Pearson's rho
|
PRIMARY outcome
Timeframe: 1-2 hoursOnline measures of statistical learning ( mean reaction time) based on item predictability during task for condition A, B or x.
Outcome measures
| Measure |
Acute Stress
n=49 Participants
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
|
No Stress
n=47 Participants
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
|
|---|---|---|
|
Statistical Learning
A condition
|
0.692 minutes
Standard Deviation 0.092
|
0.698 minutes
Standard Deviation 0.078
|
|
Statistical Learning
B condition
|
0.694 minutes
Standard Deviation 0.094
|
0.694 minutes
Standard Deviation 0.074
|
|
Statistical Learning
X condition
|
0.686 minutes
Standard Deviation 0.087
|
0.693 minutes
Standard Deviation 0.070
|
PRIMARY outcome
Timeframe: 1 hourOffline measure of statistical learning assessed through familiarity tests the next day (comparison of accurate recognition of previously-studied pairs to chance, 50%)
Outcome measures
| Measure |
Acute Stress
n=49 Participants
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
|
No Stress
n=47 Participants
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
|
|---|---|---|
|
Retention of Statistical Learning
|
0.537 correct pairs
Standard Deviation 0.247
|
0.477 correct pairs
Standard Deviation 0.188
|
PRIMARY outcome
Timeframe: 1 hourMemory 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.
Outcome measures
| Measure |
Acute Stress
n=49 Participants
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
|
No Stress
n=47 Participants
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
|
|---|---|---|
|
Episodic Memory
A condition
|
0.067 proportion of items
Standard Deviation 0.076
|
0.639 proportion of items
Standard Deviation 0.072
|
|
Episodic Memory
B condition
|
0.590 proportion of items
Standard Deviation 0.079
|
0.619 proportion of items
Standard Deviation 0.094
|
|
Episodic Memory
X condition
|
0.615 proportion of items
Standard Deviation 0.071
|
0.611 proportion of items
Standard Deviation 0.073
|
SECONDARY outcome
Timeframe: 1-2 hoursChange in salivary cortisol levels following the SECPT/control procedure
Outcome measures
| Measure |
Acute Stress
n=49 Participants
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
|
No Stress
n=47 Participants
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
|
|---|---|---|
|
Cortisol Reactivity
|
0.636 log nmol/L
Standard Deviation 0.655
|
-0.252 log nmol/L
Standard Deviation 0.475
|
SECONDARY outcome
Timeframe: 1-2 hoursChange in salivary alpha-amylase levels following the SECPT/control procedure
Outcome measures
| Measure |
Acute Stress
n=49 Participants
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
|
No Stress
n=47 Participants
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
|
|---|---|---|
|
Alpha-amylase Reactivity
|
-0.286 log nmol/L
Standard Deviation 1.270
|
-0.281 log nmol/L
Standard Deviation 1.199
|
Adverse Events
Acute Stress
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Stress
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place