Reality-monitoring & Stress (REALIST)

Hôpital le Vinatier

Status: Enrolling

Conditions: Healthy Participants

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05595434

2022-A01390-43

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

active stress group

Experimental group

Description:

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

Treatment:

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

placebo stress group

Placebo Comparator group

Description:

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

Treatment:

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