Reality-monitoring & Stress

Healthy Participants Clinical Trial

— REALIST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05595434
• Other study ID #: 2022-A01390-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: November 16, 2025

Study information

• Verified date: January 2024
• Source: Hôpital le Vinatier
• Contact: SARTLET Lydie
• Phone: 0437915531
• Email: lydie.sartelet[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 16, 2025
• Est. primary completion date: January 16, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reality-monitoring performances	scores obtained at the reality-monitoring task (accuracy, range 0-100%)	within 1 hour after the stress procedure
Secondary	electroencephalogram (EEG) activity	EEG activity recorded at rest (spectral power) and during reality-monitoring task	1time within 1 hour after the stress procedure
Secondary	Working memory	scores at the n-back task (expressed as % of good responses)	1 time within 1 hour after the stress procedure
Secondary	Basic auditory performances	scores at the Tone Matching Task (expressed as % of good responses)	1 time within 1 hour after the stress procedure
Secondary	Salivary cortisol	Salivary cortisol (in µg/L)	throughout and within 1 hour after the stress procedure
Secondary	Blood pressure	blood pressure (both systolic and diastolic, in mmHg)	throughout and within 1 hour after the stress procedure
Secondary	Heart rate	Heart rate (in beats per minute)	throughout and within 1 hour after the stress procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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