Human mental performance under acute stress
| ISRCTN | ISRCTN65723653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65723653 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 493122017 |
| Sponsor | TU Dresden |
| Funder | Deutsche Forschungsgemeinschaft |
- Submission date
- 03/02/2022
- Registration date
- 05/04/2022
- Last edited
- 05/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The SMART study investigates the fundamental question of how acute stress affects different aspects of mental abilities (cognitive processing) in humans. To explain such stress effects on cognitive processing, many different stress effect models have been developed to date. These models primarily differ in their assumptions about (1) the processes that are most strongly affected by acute stress and (2) the neurophysiological mediators of these stress effects, with the stress hormones (nor)epinephrine and cortisol being among the most promising candidates.
Who can participate?
Healthy right-handed males aged between 18 and 30 years without a history of psychiatric disorders, chronic medication use, current nicotine dependence, and current drug consumption
What does the study involve?
To investigate cognitive processing under acute stress, the study randomly administers a standardized stress-induction protocol (i.e., Maastricht Acute Stress Test) after pharmacological manipulations of exposure to stress hormones. The latter is achieved by double-blinded oral administration of a combination of 10 mg Hydrocortisone and 40 mg Atomoxetine (or corresponding pharmaceutical placebos). By manipulating both the treatment (stress) and its neurophysiological effect mediators, the study aims to identify the cognitive stress effect model that can best explain how acute stress unfolds its impact on performance change in a rapid-serial-visual-presentation (RSVP) task, a stop-signal task, a switch task, and dual task that are repeatedly completed by the participants over a prolonged period of time (i.e., 180 min before and after intervention).
What are the possible benefits and risks of participating?
All participants receive financial compensation. The individual risks associated with the study interventions are detailed in the participant information sheet. To minimize the overall participant burden due to adverse drug reactions, the maximum sample size of 328 participants will be adjusted based on the results of an internal pilot study.
Where is the study run from?
The study is run at the cognitive laboratory of the Faculty of Psychology, Technische Universität Dresden, Chemnitzer Straße 46a, 01187 Dresden, Germany.
When is the study starting and how long is it expected to run for?
January 2018 to December 2023
Who is funding the study?
The study is funded by the German Research Foundation (DFG).
Who is the main contact?
Dr. Lisa Weckesser, lisa.weckesser@tu-dresden.de
Dr. Robert Miller, robert.miller@tu-dresden.de
Contact information
Principal investigator
Institut für Klinische Psychologie und Psychotherapie, TU Dresden
Chemnitzer Straße 46a
Dresden
01187
Germany
| Phone | +49 351 46332343 |
|---|---|
| lisa.weckesser@tu-dresden.de |
Principal investigator
Institut für Klinische Psychologie und Psychotherapie, TU Dresden
Chemnitzer Straße 46a
Dresden
01187
Germany
 ORCID ID |
0000-0002-8665-5248 |
|---|---|
| Phone | +49 351 46332343 |
| robert.miller@tu-dresden.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The temporal dynamics of acute stress effects on cognitive processing in humans: An empirical evaluation of three cognitive stress effect models |
| Study acronym | SMART |
| Study objectives | Only one out of three competing models about how acute stress affects human mental performance - that is, by (1) narrowing of attention, (2) resource depletion, or (3) network shifting - can provide valid predictions about the effects of acute stress (and its physiological mediators (nor-)epinephrine and cortisol) on performance in a rapid-serial-visual-presentation task, a stop-signal task, a switch task, and dual task. The following effect patterns are predicted for these tasks by the respective model: (1) increase/increase/decrease/decrease, (2) none/decrease/decrease/decrease, (3) decrease/increase/increase/increase. The study hypothesizes that one of these effect patterns is supported by data. |
| Ethics approval(s) | Approved 17/08/2018, TU Dresden Ethics Committee, (IRB00001473/IORG0001076, Ethikkommission an der TU DresdenFetscherstrasse 74, 01307 Dresden, Germany; no telephone number provided; ethikkommission@mailbox.tu-dresden.de), ref: EK 493122017 |
| Health condition(s) or problem(s) studied | Acute stress in healthy young males |
| Intervention | Randomized, blinded oral administration of 40 mg Atomoxetine + Hydrocortisone-Placebo, Atomoxetine-Placebo + 10 mg Hydrocortisone, 40 mg Atomoxetine + 10 mg Hydrocortisone, or Atomoxetine-Placebo + Hydrocortisone-Placebo before randomized exposure to Maastricht Acute Stress Test (MAST) or Psychophysiological Non-Stress Comparator (C-MAST). Exposure to MAST and C-MAST is crossed over two study visits. |
| Intervention type | Mixed |
| Primary outcome measure(s) | Performance (response time and accuracy) is measured using a rapid-serial-visual-presentation task, a stop-signal task, a switch task, and a dual task over 90 minutes |
| Key secondary outcome measure(s) | 1. Cortisol exposure measured using Salivary Cortisone Levels over 90 minutes 2. (Nor-)epinephrine exposure measured using Blood Pressure and Heart Rate over 90 minutes 3. Mood, Awakeness, and Calmness measured using the Multidimensional Mood State Questionnaire (MDBF) over 90 minutes |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target sample size at registration | 328 |
| Key inclusion criteria | 1. Male sex 2. Right-handed 3. Age 18-30 years 4. Normal or corrected-to-normal vision |
| Key exclusion criteria | 1. History of psychiatric disorders 2. Chronic medication use 3. Current nicotine dependence 4. Current drug consumption |
| Date of first enrolment | 16/06/2020 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Chemnitzer Straße 46a
Dresden
01187
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/02/2022: Trial's existence confirmed by Technische Universität Dresden.
