Reality-monitoring & Stress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acute Maastricht Stress Test (MAST), active condition., Acute Maastricht Stress Test (MAST), placebo condition.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Reality-monitoring Process and Influence of Stress Using an Electrophysiological Approach
Overview
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
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
Interventions
- 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. - 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.
Primary outcome measures
- Reality-monitoring performances [Time frame: within 1 hour after the stress procedure]
Secondary outcome measures (12)
- electroencephalogram (EEG) activity [Time frame: 1time within 1 hour after the stress procedure]
- Working memory [Time frame: 1 time within 1 hour after the stress procedure]
- Basic auditory performances [Time frame: 1 time within 1 hour after the stress procedure]
- Salivary cortisol [Time frame: throughout and within 1 hour after the stress procedure]
- Blood pressure [Time frame: throughout and within 1 hour after the stress procedure]
- Heart rate [Time frame: throughout and within 1 hour after the stress procedure]
- expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway [Time frame: 1 time before and 1 time 1 hour after the stress procedure]
- Subjective stress [Time frame: 1 time before and 1 time 1 hour after the stress procedure]
- Psychometric characteristics that may influence stress response (1) [Time frame: Basline, before the stress procedure]
- Psychometric characteristics that may influence stress response (2) [Time frame: Basline, before the stress procedure]
- Psychometric characteristics that may influence stress response (3) [Time frame: Basline, before the stress procedure]
- Psychometric characteristics that may influence stress response (4) [Time frame: Basline, before the stress procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
France · 1 center
- Centre Hospitalier le Vinatier — Bron
Identifiers
NCT: NCT05595434 · 2022-A01390-43