Reality-monitoring & Stress

NCT05595434 | Recruiting

• 1 other identifier: 2022-A01390-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Participants

Keywords

reality-monitoring; stress

Outcome Measures

Primary Outcomes (1)

• Reality-monitoring performances

  scores obtained at the reality-monitoring task (accuracy, range 0-100%)

  within 1 hour after the stress procedure

Secondary Outcomes (13)

• electroencephalogram (EEG) activity

  1time within 1 hour after the stress procedure

• Working memory

  1 time within 1 hour after the stress procedure

• Basic auditory performances

  1 time within 1 hour after the stress procedure

• Salivary cortisol

  throughout and within 1 hour after the stress procedure

• Blood pressure

  throughout and within 1 hour after the stress procedure

Study Arms (2)

active stress group

EXPERIMENTAL

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

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

placebo stress group

PLACEBO COMPARATOR

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

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

Interventions

Acute Maastricht Stress Test (MAST), active condition. PROCEDURE

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.

active stress group

Acute Maastricht Stress Test (MAST), placebo condition PROCEDURE

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.

placebo stress group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier le Vinatier

Bron, 69678, France

RECRUITING

Study Officials

• Mondino Marine, PhD

  hospital le vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SARTLET Lydie

CONTACT

0437915531; lydie.sartelet@ch-le-vinatier.fr

Mondino Marine, PhD

CONTACT

0437915565; marine.mondino@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed about the nature (active or placebo) of the stress test they will perform.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, single-blind study including 40 healthy subjects who will be randomly divided into 2 groups.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 27, 2022
• Study Start: April 25, 2024
• Primary Completion: October 25, 2025
• Study Completion: November 16, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

FR (1)