Reality-monitoring & Stress

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Reality-monitoring performances [Срок оценки: within 1 hour after the stress procedure]

Вторичные конечные точки (12)

• electroencephalogram (EEG) activity [Срок оценки: 1time within 1 hour after the stress procedure]
• Working memory [Срок оценки: 1 time within 1 hour after the stress procedure]
• Basic auditory performances [Срок оценки: 1 time within 1 hour after the stress procedure]
• Salivary cortisol [Срок оценки: throughout and within 1 hour after the stress procedure]
• Blood pressure [Срок оценки: throughout and within 1 hour after the stress procedure]
• Heart rate [Срок оценки: throughout and within 1 hour after the stress procedure]
• expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway [Срок оценки: 1 time before and 1 time 1 hour after the stress procedure]
• Subjective stress [Срок оценки: 1 time before and 1 time 1 hour after the stress procedure]
• Psychometric characteristics that may influence stress response (1) [Срок оценки: Basline, before the stress procedure]
• Psychometric characteristics that may influence stress response (2) [Срок оценки: Basline, before the stress procedure]
• Psychometric characteristics that may influence stress response (3) [Срок оценки: Basline, before the stress procedure]
• Psychometric characteristics that may influence stress response (4) [Срок оценки: Basline, before the stress procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Centre Hospitalier le Vinatier — Bron

Идентификаторы

NCT: NCT05595434 · 2022-A01390-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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