Study of the Difference Between Anorexia Nervosa with a History (s) of Psychological Trauma (AM-T) and Classical Anorexia Nervosa (AM-C) on the Neurocognitive and Neurophysiological Factors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)
研究概览
简要总结
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.
详细描述
We will recruit a total of 100 patients with a diagnosis of anorexia nervosa in the university hospital of Montpellier : 50 patients with an history of psychological trauma and 50 patients without any history of psychological trauma
Participation consists of a half-day visit. Patients will perform clinical and neuropsychological assessments and an exposition test. During this test, participants will be exposed, for 7 minutes, to neutral, positive or negative emotional photos. Heart rate variability will be determined through a Biopac MP160 before, during and after this event. Saliva samples to measure kynurenin, tryptophan, substance P and neurokinin-1 will be collected before and directly after the test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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 cardiovascular system
- •Refusal of the patient
- •Be protected by law (tutorship or curatorship).
- •To be deprived of liberty by administrative decision.
研究组 & 干预措施
Anorexic women
Anorexic women with or without history of psychological trauma will perform study procedure : sociodemographic and clinical assessments, measurement of cardiac variability and salivary cortisol changes, before, during and after the exposition test.
干预措施: Exposition Test (Behavioral)
结局指标
主要结局
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)
时间窗: inclusion visit
We aim to investigate if AM-T patients present changes in HF-HRV across exposition test compared to AM-C patients, measured by Biopac MP160
次要结局
- Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)(inclusion visit)
- Changes in low frequency heart variability (LF-HRV) across the exposition test (before, during and after)(inclusion visit)
- Score to the Beck depression inventory II(inclusion visit)
- Score to the Eating Disorder Questionnaire(inclusion visit)
- Changes in the interval between R peaks (R-R across the exposition test (before, during and after)(inclusion visit)
- Changes in the root mean successive squared differences of the R-R interval (RMSSD). across the exposition test (before, during and after)(inclusion visit)
- Score to the Difficulties in Emotion Regulation Scale(inclusion visit)
- Score to the Delay Discounting Test(inclusion visit)
- Changes in the highest peak of the high frequency (HFhz) across the exposition test (before, during and after)(inclusion visit)
- Score to the Eating Disorder Inventory(inclusion visit)
- Score to the Childhood trauma questionnaire(inclusion visit)
- Score to the Trail Making Test(inclusion visit)
- Changes in salivary tryptophan(inclusion visit)
- Changes in the R-R interval standard difference (STD-RR) across the exposition test (before, during and after)(inclusion visit)
- Score to the PTSD Checklist for DSM-5(inclusion visit)
- Changes in salivary kynurenine(inclusion visit)
- Changes in salivary neurokinin-1(inclusion visit)
- Score to the Wisconson Card Sorting Test(inclusion visit)
- Score to the Stroop Test(inclusion visit)
- Changes in salivary P substance(inclusion visit)