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Assessing the Repeatability of a Psychological Stress Test

NCT04714450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-06

No results posted yet for this study

Summary

To establish the efficacy and repeatability of a suitable psychological stress test. The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. Despite the test increasing self-reported levels of stress, meaningful changes in saliva cortisol are typically observed in only half of all participants. In addition, the MMST is susceptible to habituation of the cortisol response upon repeated exposures, limiting its current usefulness for repeated measures. Given the multicomponent nature of the MMST, there is potential for components of the test to be manipulated to overcome these limitations i.e., increase the magnitude of the saliva cortisol response and mitigate against habituation effects. In addition, a supplementary topic of interest is to what extent cortisol responses to acute laboratory stress tests, like the MMST, relate to the well described rise in morning cortisol \~30 minutes after awakening. This may be of clinical relevance given that blunted cortisol response upon awakening and in response to acute psychological stress tests have been associated with poor health outcomes.

The primary objective of the current study is to investigate if the MMST elicits a meaningful increase in saliva cortisol.

The secondary objective is to investigate the efficacy of mitigation strategies to overcome habituation to the MMST.

A supplementary objective is to to investigate the relationship between the saliva cortisol response upon awakening and the saliva cortisol response to the MMST.

Conditions

  • Stress, Physiological
  • Stress, Psychological

Interventions

BEHAVIORAL

Experimental: MMST+

The format of the MMST will remain the same; however, the white noise, images and math task will be modified to mitigate habituation effects.

Sponsors & Collaborators

  • Danone Nutricia Research

    collaborator INDUSTRY

  • Liverpool John Moores University

    lead OTHER

Principal Investigators

  • Neil P Walsh, PHD · Liverpool John Moores University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2023-07-19
Completion
2023-07-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714450 on ClinicalTrials.gov