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Reality-monitoring & Stress

Study of Reality-monitoring Process and Influence of Stress Using an Electrophysiological Approach

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05595434
Acronym
REALIST
Enrollment
40
Registered
2022-10-27
Start date
2024-04-25
Completion date
2025-11-16
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

reality-monitoring, stress

Brief 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

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

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.

Sponsors

Hôpital le Vinatier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants will not be informed about the nature (active or placebo) of the stress test they will perform.

Intervention model description

Randomized, controlled, single-blind study including 40 healthy subjects who will be randomly divided into 2 groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Reality-monitoring performanceswithin 1 hour after the stress procedurescores obtained at the reality-monitoring task (accuracy, range 0-100%)

Secondary

MeasureTime frameDescription
Working memory1 time within 1 hour after the stress procedurescores at the n-back task (expressed as % of good responses)
Basic auditory performances1 time within 1 hour after the stress procedurescores at the Tone Matching Task (expressed as % of good responses)
Salivary cortisolthroughout and within 1 hour after the stress procedureSalivary cortisol (in µg/L)
Blood pressurethroughout and within 1 hour after the stress procedureblood pressure (both systolic and diastolic, in mmHg)
Heart ratethroughout and within 1 hour after the stress procedureHeart rate (in beats per minute)
expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway1 time before and 1 time 1 hour after the stress procedureThe expression rate of genes of the glucocorticoid receptor signaling pathway (NR3C1, FKBP4, HSP90, HSP70, FKBP5, BAG1, PTGES3)
electroencephalogram (EEG) activity1time within 1 hour after the stress procedureEEG activity recorded at rest (spectral power) and during reality-monitoring task
Psychometric characteristics that may influence stress response (1)Basline, before the stress procedureScores at the 16-item Prodromal Questionnaire (PQ-16), ranging between 0 and 16 (higher scores indicate higher psychotic risks).
Psychometric characteristics that may influence stress response (2)Basline, before the stress procedureScores at the Childhood Trauma Questionnaire (CTQ), between 28 and 140 (higher scores indicate higher trauma exposure)
Psychometric characteristics that may influence stress response (3)Basline, before the stress procedureState 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)
Psychometric characteristics that may influence stress response (4)Basline, before the stress procedureScores at the Schizotypal Personality Questionnaire (SPQ), between 0 and 74 (higher scores indicate higher schizotypal traits)
Psychometric characteristics that may influence stress response (5)Basline, before the stress procedureScores at the Launay-Slade Hallucinations Scale (LSHS), between 0 and 64 (higher scores indicate a greater likelihood of experiencing hallucinations)
Subjective stress1 time before and 1 time 1 hour after the stress procedureSubjective stress assessed with the STAI-YA (scores between 20 and 80)

Countries

France

Contacts

Primary ContactSARTLET Lydie
lydie.sartelet@ch-le-vinatier.fr0437915531
Backup ContactMondino Marine, PhD
marine.mondino@ch-le-vinatier.fr0437915565

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026