Reality-monitoring & Stress (REALIST)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Procedure: Acute Maastricht Stress Test (MAST), active condition.; Procedure: Acute Maastricht Stress Test (MAST), placebo condition

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SARTLET Lydie; Phone Number: +33 0437915531; Email: lydie.sartelet@ch-le-vinatier.fr
• Study Contact Backup: Name: Mondino Marine, PhD; Phone Number: +33 0437915565; Email: marine.mondino@ch-le-vinatier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electroencephalogram (EEG) activity	EEG activity recorded at rest (spectral power) and during reality-monitoring task	1time within 1 hour after the stress procedure
Working memory	scores at the n-back task (expressed as % of good responses)	1 time within 1 hour after the stress procedure
Basic auditory performances	scores at the Tone Matching Task (expressed as % of good responses)	1 time within 1 hour after the stress procedure
Salivary cortisol	Salivary cortisol (in µg/L)	throughout and within 1 hour after the stress procedure
Blood pressure	blood pressure (both systolic and diastolic, in mmHg)	throughout and within 1 hour after the stress procedure
Heart rate	Heart rate (in beats per minute)	throughout and within 1 hour after the stress procedure
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)	1 time before and 1 time 1 hour after the stress procedure
Subjective stress	Subjective stress assessed with the STAI-YA (scores between 20 and 80)	1 time before and 1 time 1 hour after the stress procedure
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).	Basline, before the stress procedure
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)	Basline, before the stress procedure
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)	Basline, before the stress procedure
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)	Basline, before the stress procedure
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)	Basline, before the stress procedure

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: Mondino Marine, PhD, hospital le Vinatier

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): January 16, 2025
• Study Completion (Estimated): November 16, 2025

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: stress; reality-monitoring
• Other Study ID Numbers: 2022-A01390-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No