Clinical trial NCT05595434: Reality-monitoring & Stress
Official title: Study of Reality-monitoring Process and Influence of Stress Using an Electrophysiological Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Participants
Keywords: reality-monitoring
stress
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blind study including 40 healthy subjects who will be randomly divided into 2 groups.
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Reality-monitoring performances
timeFrame: within 1 hour after the stress procedure
Secondary outcomes:
measure: electroencephalogram (EEG) activity
timeFrame: 1time within 1 hour after the stress procedure
measure: Working memory
timeFrame: 1 time within 1 hour after the stress procedure
measure: Basic auditory performances
timeFrame: 1 time within 1 hour after the stress procedure
measure: Salivary cortisol
timeFrame: throughout and within 1 hour after the stress procedure
measure: Blood pressure
timeFrame: throughout and within 1 hour after the stress procedure
measure: Heart rate
timeFrame: throughout and within 1 hour after the stress procedure
measure: expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway
timeFrame: 1 time before and 1 time 1 hour after the stress procedure
measure: Subjective stress
timeFrame: 1 time before and 1 time 1 hour after the stress procedure
measure: Psychometric characteristics that may influence stress response (1)
timeFrame: Basline, before the stress procedure
measure: Psychometric characteristics that may influence stress response (2)
timeFrame: Basline, before the stress procedure
measure: Psychometric characteristics that may influence stress response (3)
timeFrame: Basline, before the stress procedure
measure: Psychometric characteristics that may influence stress response (4)
timeFrame: Basline, before the stress procedure
measure: Psychometric characteristics that may influence stress response (5)
timeFrame: Basline, before the stress procedure
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier le Vinatier
Study officials:
affiliation: hospital le vinatier
name: Mondino Marine, PhD
role: PRINCIPAL_INVESTIGATOR
References: