NCT Number: NCT05595434
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
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Bron, 69678, France
Location status: Recruiting
Jerome Brunelin
SUB_INVESTIGATOR
Jérôme Brunelin
CONTACT
0437915297 ext. +33
Marine Mondino
CONTACT
0437915565 ext. +33
Marine Mondino
PRINCIPAL_INVESTIGATOR
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: within 1 hour after the stress procedure
scores obtained at the reality-monitoring task (accuracy, range 0-100%)
Time frame: 1time within 1 hour after the stress procedure
EEG activity recorded at rest (spectral power) and during reality-monitoring task
Time frame: 1 time within 1 hour after the stress procedure
scores at the n-back task (expressed as % of good responses)
Time frame: 1 time within 1 hour after the stress procedure
scores at the Tone Matching Task (expressed as % of good responses)
Time frame: throughout and within 1 hour after the stress procedure
Salivary cortisol (in µg/L)
Time frame: throughout and within 1 hour after the stress procedure
blood pressure (both systolic and diastolic, in mmHg)
Time frame: throughout and within 1 hour after the stress procedure
Heart rate (in beats per minute)
Time frame: 1 time before and 1 time 1 hour after the stress procedure
The expression rate of genes of the glucocorticoid receptor signaling pathway (NR3C1, FKBP4, HSP90, HSP70, FKBP5, BAG1, PTGES3)
Time frame: 1 time before and 1 time 1 hour after the stress procedure
Subjective stress assessed with the STAI-YA (scores between 20 and 80)
Time frame: Basline, before the stress procedure
Scores at the 16-item Prodromal Questionnaire (PQ-16), ranging between 0 and 16 (higher scores indicate higher psychotic risks).
Time frame: Basline, before the stress procedure
Scores at the Childhood Trauma Questionnaire (CTQ), between 28 and 140 (higher scores indicate higher trauma exposure)
Time frame: Basline, before the stress procedure
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)
Time frame: Basline, before the stress procedure
Scores at the Schizotypal Personality Questionnaire (SPQ), between 0 and 74 (higher scores indicate higher schizotypal traits)
Time frame: Basline, before the stress procedure
Scores at the Launay-Slade Hallucinations Scale (LSHS), between 0 and 64 (higher scores indicate a greater likelihood of experiencing hallucinations)
Contact information is provided by the study sponsor or research team.
Hôpital le Vinatier
Other
Study of Reality-monitoring Process and Influence of Stress Using an Electrophysiological Approach
Acronym: REALIST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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