Reality-monitoring & Stress

Not Applicable

Recruiting

• Conditions: Healthy Participants

• Registration Number: NCT05595434
• Lead Sponsor: Hôpital le Vinatier

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

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Study Start: 2024-04-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-24
• Primary Completion: 2025-10-25
• Study Completion: 2025-11-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reality-monitoring performances	within 1 hour after the stress procedure	scores obtained at the reality-monitoring task (accuracy, range 0-100%)

Secondary Outcome Measures

Name	Time	Method
Subjective stress	1 time before and 1 time 1 hour after the stress procedure	Subjective stress assessed with the STAI-YA (scores between 20 and 80)
electroencephalogram (EEG) activity	1time within 1 hour after the stress procedure	EEG activity recorded at rest (spectral power) and during reality-monitoring task
Working memory	1 time within 1 hour after the stress procedure	scores at the n-back task (expressed as % of good responses)
Heart rate	throughout and within 1 hour after the stress procedure	Heart rate (in beats per minute)
Blood pressure	throughout and within 1 hour after the stress procedure	blood pressure (both systolic and diastolic, in mmHg)
Salivary cortisol	throughout and within 1 hour after the stress procedure	Salivary cortisol (in µg/L)
Psychometric characteristics that may influence stress response (1)	Basline, before the stress procedure	Scores at the 16-item Prodromal Questionnaire (PQ-16), ranging between 0 and 16 (higher scores indicate higher psychotic risks).
expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway	1 time before and 1 time 1 hour after the stress procedure	The expression rate of genes of the glucocorticoid receptor signaling pathway (NR3C1, FKBP4, HSP90, HSP70, FKBP5, BAG1, PTGES3)
Basic auditory performances	1 time within 1 hour after the stress procedure	scores at the Tone Matching Task (expressed as % of good responses)
Psychometric characteristics that may influence stress response (3)	Basline, before the stress procedure	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)
Psychometric characteristics that may influence stress response (2)	Basline, before the stress procedure	Scores at the Childhood Trauma Questionnaire (CTQ), between 28 and 140 (higher scores indicate higher trauma exposure)
Psychometric characteristics that may influence stress response (4)	Basline, before the stress procedure	Scores 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 procedure	Scores at the Launay-Slade Hallucinations Scale (LSHS), between 0 and 64 (higher scores indicate a greater likelihood of experiencing hallucinations)

Trial Locations

Locations (1)

Centre Hospitalier le Vinatier; 🇫🇷 Bron, France