Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Class… (NCT04804358) | Clinical Trial Compass
TerminatedNot Applicable
Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors
Stopped: The person in charge of the clinical study had to leave the hospital prematurely.
France4 participantsStarted 2021-09-17
Plain-language summary
Recent studies suggest that patients with an history of trauma may represent a specific subtype of anorexia nervosa (AM) underlined by specific neurobiological and psychopathological mechanisms. Thus, AM-T subjects would manifest cognitive (specific difficulties in executive functions), emotional (emotional disruption, impulsivity, etc.) and neurobiological (secretion of kynurenine and neurokinins in the face of stress) caracteristics different from those of AM subjects.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria common to the 2 groups AM-T and AM-C :
* Women Patient
* Present a diagnosis of anorexia nervosa according to the DSM-5 criteria
* Between 18 and 65 years old
* Present a BMI\> 14
* Do not present a sight problem or be corrected appropriately by wearing glasses or contact lenses.
* Be affiliated to a social security scheme, or beneficiary of such a scheme
* Be able to understand the nature, purpose and methodology of the study
Inclusion criteria specific to patients in the AM-T group:
\- To have answered at least one of the grayed out items of the LEC-5, that is to say to have answered "it happened to me" to at least one of the items 1 to 13 or to item 16 "and / or having answered" I witnessed it "to at least one of items 14 and 15.
Inclusion criteria specific to patients in the AM-C group:
\- Not having answered "it happened to me" or "I witnessed it" to one of the items of LEC-5
Exclusion Criteria:
* Present a severe unstable mental pathology in the opinion of the investigator
* Present active suicidal ideation
* Have consumed psychoactive substances in the last 24 hours before the assessment
* Present a severe major depressive episode incompatible with the assessment, in the opinion of the investigator.
* Present in the opinion of the investigator an unstable somatic state (eg severe metabolic disorder making it impossible or likely to impair the reliability of neuropsychological and cardiac evaluations).
* Take a drug treatment acting on the card…
What they're measuring
1
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)