Reality-monitoring & Stress

NCT ID: NCT05595434

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2025-11-16

Brief Summary

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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

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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

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, single-blind study including 40 healthy subjects who will be randomly divided into 2 groups.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not be informed about the nature (active or placebo) of the stress test they will perform.

Study Groups

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active stress group

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

Group Type EXPERIMENTAL

Acute Maastricht Stress Test (MAST), active condition.

Intervention Type 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.

placebo stress group

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

Group Type PLACEBO_COMPARATOR

Acute Maastricht Stress Test (MAST), placebo condition

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mondino Marine, PhD

Role: PRINCIPAL_INVESTIGATOR

hospital le vinatier

Locations

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Centre Hospitalier le Vinatier

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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SARTLET Lydie

Role: CONTACT

0437915531 ext. +33

Mondino Marine, PhD

Role: CONTACT

0437915565 ext. +33

Facility Contacts

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Marine Mondino

Role: primary

0437915565 ext. +33

Jérôme Brunelin

Role: backup

0437915297 ext. +33

Other Identifiers

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2022-A01390-43

Identifier Type: -

Identifier Source: org_study_id

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