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Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors

Not Applicable
Terminated
Conditions
Anorexia Nervosa
Interventions
Behavioral: Exposition Test
Registration Number
NCT04804358
Lead Sponsor
University Hospital, Montpellier
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
4
Inclusion Criteria

Not provided

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 cardiovascular system
  • Refusal of the patient
  • Be protected by law (tutorship or curatorship).
  • To be deprived of liberty by administrative decision.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Anorexic womenExposition TestAnorexic 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.
Primary Outcome Measures
NameTimeMethod
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)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

Secondary Outcome Measures
NameTimeMethod
Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)inclusion visit

We aim to investigate if AM-T patients present changes in VLF-HRV across exposition test compared to AM-C patients, measured by Biopac MP160

Changes in low frequency heart variability (LF-HRV) across the exposition test (before, during and after)inclusion visit

We aim to investigate if AM-T patients present changes in LF-HRV across exposition test compared to AM-C patients, measured by Biopac MP160

Score to the Beck depression inventory IIinclusion visit

We aim to assess the link between eating symptomatology and psychological trauma in AN. The BDI-II is a self-administered questionnaire assessing the severity of depressive symptoms in 21 items. Each item is rated on a 4-points Likert scale ranging from 0 to 3. The total score varies between 0 and 63. higher scores mean more depressive symptoms

Score to the Eating Disorder Questionnaireinclusion visit

We aim to assess the link betxeen eating symptomatology and psychological trauma in AN. self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6 are obtained.Higher scores mean higher eating concerns

Changes in the interval between R peaks (R-R across the exposition test (before, during and after)inclusion visit

We aim to investigate if AM-T patients present R-R changes across exposition test compared to AM-C patients, measured by Biopac MP160

Changes in the root mean successive squared differences of the R-R interval (RMSSD). across the exposition test (before, during and after)inclusion visit

We aim to investigate if AM-T patients present RMSSD changes across exposition test compared to AM-C patients, measured by Biopac MP160

Score to the Difficulties in Emotion Regulation Scaleinclusion visit

We aim to assess the link between emotional regulation and psychological trauma in AN. DERS is a self-assessment scale measuring emotion dysregulation. The original DERS includes 36 items scored 1-5 where 1 is almost never, 2 is sometimes, 3 is about half the time, 4 is most of the time, and 5 is almost always. Of the 36 items, 11 are reverse scored. The DERS-36 yields a total score as well as six subscales where higher scores indicate more difficulties.

Score to the Delay Discounting Testinclusion visit

We aim to assess the link between decision making and psychological trauma in AN

Changes in the highest peak of the high frequency (HFhz) across the exposition test (before, during and after)inclusion visit

We aim to investigate if AM-T patients present changes in HFhz across exposition test compared to AM-C patients, measured by Biopac MP160

Score to the Eating Disorder Inventoryinclusion visit

We aim to assess the link between eating symptomatology and psychological trauma in AN. The EDI-2 is a 91-item self-report questionnaire assessing cognitive, emotional, and behavioral symptoms of eating disorders. It rates from 0 to 273. Higher scores means severe symptoms

Score to the Childhood trauma questionnaireinclusion visit
Score to the Trail Making Testinclusion visit

We aim to assess the link between mental flexibility, visio-spatial attention, processing speed and psychological trauma in AN

Changes in salivary tryptophaninclusion visit

study changes in salivary tryptophan before and after exposition test

Changes in the R-R interval standard difference (STD-RR) across the exposition test (before, during and after)inclusion visit

We aim to investigate if AM-T patients present STD-RR changes across exposition test compared to AM-C patients, measured by Biopac MP160

Score to the PTSD Checklist for DSM-5inclusion visit
Changes in salivary kynurenineinclusion visit

study changes in salivary kynurenine before and after exposition test

Changes in salivary neurokinin-1inclusion visit

study changes in salivary neurokinin-1before and after exposition test

Score to the Wisconson Card Sorting Testinclusion visit

We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN

Score to the Stroop Testinclusion visit

We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN

Changes in salivary P substanceinclusion visit

study changes in salivary P substance before and after exposition test

Trial Locations

Locations (1)

University Hospital, Montpellier

🇫🇷

Montpellier, France

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