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RecruitingNCT05595434REALISTUpdated Jul 24, 2025

Reality-monitoring & Stress

An interventional study of Acute Maastricht Stress Test (MAST), active condition. and Acute Maastricht Stress Test (MAST), placebo condition in Healthy Participants, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

Reality-monitoring is a crucial cognitive process in daily life to remember the source of an information. Deficits of reality-monitoring have been shown into the continuum of schizophrenia, suggesting a preexisting alteration in population at-risk for psychosis that will be exacerbated during psychotic transition. It is admitted that stress plays a crucial role in the psychotic transition and can alter cognitive performances. However, less is known about the effects of stress on reality-monitoring, even though this process appears to be central in psychotic disorders.

The aim of this project is to investigate the effect of stress on reality-monitoring, both on behavioral and neurophysiological aspects

Read the detailed description

Forty healthy subjects will be included in the study. Participants will be subject to a standardized stress protocol, half of them receiving an active stress and the other half receiving a placebo. All participants will also complete a reality-monitoring task, electrophysiological (EEG) recordings as well as socio-demographic and psychometric evaluations

02

Conditions studied

  • Healthy Participants

Keywords

  • reality-monitoring
  • stress
03

In context

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Right-handed Men and Women aged between 18 and 30
  • Having given their written informed consent
  • For women: oral contraceptive use
  • French speakers and readers

Exclusion criteria

Exclusion Criteria:

  • Do not consent to be included in the study
  • Smokers
  • Night workers
  • Having visual or hearing impairments that could prevent the successful completion of tasks involving reading or listening to sounds
  • Taking drug treatment (except oral contraceptive)
  • Having a somatic pathology in particular neurological, endocrinal or blood circulation diseases (e.g., Raynaud's disease)
  • Having personal or first-degree relatives' history of diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5)
  • Having psychotic prodomes measured by a score above 6 in the "prodomal questionnaire' - PQ-16 (Ising et al., 2012)
  • Having developed musical abilities (that is, regularly practicing a musical instrument)
  • Being pregnant or nursing
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    active stress group

    20 healthy subjects will be subject to the active condition of a standardized stress protocol

    Procedure: Acute Maastricht Stress Test (MAST), active condition.

  • Placebo comparator
    placebo stress group

    20 healthy subjects will be subject to the placebo condition of a standardized stress protocol.

    Procedure: Acute Maastricht Stress Test (MAST), placebo condition

Interventions

  • ProcedureAcute Maastricht Stress Test (MAST), active condition.

    The MAST is a standardized stress protocol combining a 5 min preparation phase and 10 min acute stress phase. The last phase is composed by an alternation of physical and psychosocial stressors. In the active condition, participants have to switch between immersion of the hand into cold water and complex mental arithmetic operations.

  • ProcedureAcute Maastricht Stress Test (MAST), placebo condition

    The MAST is a standardized stress protocol combining a 5 min preparation phase and 10 min acute stress phase. The last phase is composed by an alternation of physical and psychosocial stressors. In the placebo condition, participants have to switch between immersion of the hand into tempered water and simple mental arithmetic counts.

06

What researchers measure

Primary outcomes

  1. Reality-monitoring performances

    scores obtained at the reality-monitoring task (accuracy, range 0-100%)

    Time frame: within 1 hour after the stress procedure

Secondary outcomes

  1. electroencephalogram (EEG) activity

    EEG activity recorded at rest (spectral power) and during reality-monitoring task

    Time frame: 1time within 1 hour after the stress procedure

  2. Working memory

    scores at the n-back task (expressed as % of good responses)

    Time frame: 1 time within 1 hour after the stress procedure

  3. Basic auditory performances

    scores at the Tone Matching Task (expressed as % of good responses)

    Time frame: 1 time within 1 hour after the stress procedure

  4. Salivary cortisol

    Salivary cortisol (in µg/L)

    Time frame: throughout and within 1 hour after the stress procedure

  5. Blood pressure

    blood pressure (both systolic and diastolic, in mmHg)

    Time frame: throughout and within 1 hour after the stress procedure

  6. Heart rate

    Heart rate (in beats per minute)

    Time frame: throughout and within 1 hour after the stress procedure

  7. expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway

    The expression rate of genes of the glucocorticoid receptor signaling pathway (NR3C1, FKBP4, HSP90, HSP70, FKBP5, BAG1, PTGES3)

    Time frame: 1 time before and 1 time 1 hour after the stress procedure

  8. Subjective stress

    Subjective stress assessed with the STAI-YA (scores between 20 and 80)

    Time frame: 1 time before and 1 time 1 hour after the stress procedure

  9. Psychometric characteristics that may influence stress response (1)

    Scores at the 16-item Prodromal Questionnaire (PQ-16), ranging between 0 and 16 (higher scores indicate higher psychotic risks).

    Time frame: Basline, before the stress procedure

  10. Psychometric characteristics that may influence stress response (2)

    Scores at the Childhood Trauma Questionnaire (CTQ), between 28 and 140 (higher scores indicate higher trauma exposure)

    Time frame: Basline, before the stress procedure

  11. Psychometric characteristics that may influence stress response (3)

    State Trait Anxiety Inventory (form B) scores between 40 and 160 20 and 80 (STAI-YB) between 20 and 80 (higher scores indicate higher state anxiety)

    Time frame: Basline, before the stress procedure

  12. Psychometric characteristics that may influence stress response (4)

    Scores at the Schizotypal Personality Questionnaire (SPQ), between 0 and 74 (higher scores indicate higher schizotypal traits)

    Time frame: Basline, before the stress procedure

  13. Psychometric characteristics that may influence stress response (5)

    Scores at the Launay-Slade Hallucinations Scale (LSHS), between 0 and 64 (higher scores indicate a greater likelihood of experiencing hallucinations)

    Time frame: Basline, before the stress procedure

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05595434
Lead sponsor
Hôpital le Vinatier
Responsible party
Sponsor
First posted
Oct 27, 2022
Start date
Apr 25, 2024
Primary completion
Oct 25, 2025 (estimated)
Completion
Nov 16, 2025 (estimated)
Last update
Jul 24, 2025

Study contacts

SARTLET Lydie
Contact
lydie.sartelet@ch-le-vinatier.fr
0437915531 ext. +33
Mondino Marine, PhD
Contact
marine.mondino@ch-le-vinatier.fr
0437915565 ext. +33
Mondino Marine, PhD
principal investigator · hospital le vinatier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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