NCT05026333

Cognitive and Biological Responses in Stress

Completed NA Last updated 12 October 2022

What this trial tests

NA trial testing Cognitive Stress Testing in Stress, Psychological in 100 participants. Completed in 15 July 2022.

Timeline

25 June 2021

Primary endpoint
15 July 2022

15 July 2022

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	100
Start date	25 June 2021
Primary completion	15 July 2022
Estimated completion	15 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Stress Testing

Conditions studied

• Stress, Psychological — all drugs for Stress, Psychological →
• Anxiety — all drugs for Anxiety →

Sponsor

University of California, Los Angeles

Who can join

Adults 18 to 45, female only, with Stress, Psychological or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this pilot part of the study (Step 1) is to identify the optimal population of high and low anxiety and stress individuals who will differentially respond to a laboratory stress task as measured by changes in subjective stress response (affect), cognition, attention, and biological measures (autonomic and metabolite responses).

Based on experience with different study populations, the investigator's believe that a healthy, homogenous population (Caucasian, women, premenopausal) with higher levels of state anxiety and perceived stress, and with greater responsiveness to laboratory stress tasks (which can also be used in the probiotic intervention study in Step 2) will provide the highest likelihood of identifying the underlying central mechanisms of stress responsiveness in Step 1 and then for the probiotic intervention in Step 2.

For this pilot study, the investigator's will look at baseline measures to determine differences in responses to four subjective (affect/cognition/attention) stress tasks (primary endpoints) and biological (secondary endpoints) measures in a high stress group and a low stress group.

If for Step 1 of the study, the investigator's are able to verify the stratification of the participants into high and low stress groups based on questionnaire data and show differences between participants with high and low perceived stress in psychological characteristics, lab stress tasks and potentially in biological responses, this will help to determine the optimal cut off values, and the optimal stress tasks to be conducted in the planned probiotic intervention study of Step 2.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.