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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 (ATAC)

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposition Test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring anorexia nervosa, Psychological Trauma, Heart Rate Variability, Kynurenine, Substance P

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Anorexic women

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)
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

Changes in low frequency heart variability (LF-HRV) across the exposition test (before, during and after)
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
Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)
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 the highest peak of the high frequency (HFhz) across the exposition test (before, during and after)
We aim to investigate if AM-T patients present changes in HFhz across exposition test compared to AM-C patients, measured by Biopac MP160
Changes in the interval between R peaks (R-R across the exposition test (before, during and after)
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 R-R interval standard difference (STD-RR) across the exposition test (before, during and after)
We aim to investigate if AM-T patients present STD-RR 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)
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 Scale
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 Beck depression inventory II
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 Questionnaire
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
Score to the Eating Disorder Inventory
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 questionnaire
Score to the PTSD Checklist for DSM-5
Score to the Wisconson Card Sorting Test
We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN
Score to the Stroop Test
We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN
Score to the Delay Discounting Test
We aim to assess the link between decision making and psychological trauma in AN
Score to the Trail Making Test
We aim to assess the link between mental flexibility, visio-spatial attention, processing speed and psychological trauma in AN
Changes in salivary tryptophan
study changes in salivary tryptophan before and after exposition test
Changes in salivary kynurenine
study changes in salivary kynurenine before and after exposition test
Changes in salivary P substance
study changes in salivary P substance before and after exposition test
Changes in salivary neurokinin-1
study changes in salivary neurokinin-1before and after exposition test

Full Information

First Posted
March 10, 2021
Last Updated
December 31, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04804358
Brief Title
Study of the Difference Between Anorexia Nervosa With a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors
Acronym
ATAC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, Psychological Trauma, Heart Rate Variability, Kynurenine, Substance P

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anorexic women
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposition Test
Intervention Description
During this test (7 minutes) participants will be exposed to photos evoking positive or negative emotions (anger, disgust, sadness and fear) interspersed with emotionally neutral photos. The test sequence is composed of 3 blocks as follows: 12 photos evoking positive emotions (2 min) Pause of 30 seconds (white screen) 12 photos presenting a neutral emotional valence (2 min) Pause of 30 seconds (white screen) 12 photos evoking negative emotions (2min) In each block, photos will be selected and presented to the participant in a randomized and sequential manner. In total, 30 photos will be presented in 7 minutes to each participant (10 seconds per photo). The participant must be at rest in front of the computer screen during these 7 minutes with optimal visibility. The photos will be presented sequentially using software (E-Prime or Visual Basic 6.0). During this exposure test, a heart rate recording will be made using a BIOPAC MP160 recording system.
Primary Outcome Measure Information:
Title
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)
Description
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
Time Frame
inclusion visit
Secondary Outcome Measure Information:
Title
Changes in low frequency heart variability (LF-HRV) across the exposition test (before, during and after)
Description
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
Time Frame
inclusion visit
Title
Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)
Description
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
Time Frame
inclusion visit
Title
Changes in the highest peak of the high frequency (HFhz) across the exposition test (before, during and after)
Description
We aim to investigate if AM-T patients present changes in HFhz across exposition test compared to AM-C patients, measured by Biopac MP160
Time Frame
inclusion visit
Title
Changes in the interval between R peaks (R-R across the exposition test (before, during and after)
Description
We aim to investigate if AM-T patients present R-R changes across exposition test compared to AM-C patients, measured by Biopac MP160
Time Frame
inclusion visit
Title
Changes in the R-R interval standard difference (STD-RR) across the exposition test (before, during and after)
Description
We aim to investigate if AM-T patients present STD-RR changes across exposition test compared to AM-C patients, measured by Biopac MP160
Time Frame
inclusion visit
Title
Changes in the root mean successive squared differences of the R-R interval (RMSSD). across the exposition test (before, during and after)
Description
We aim to investigate if AM-T patients present RMSSD changes across exposition test compared to AM-C patients, measured by Biopac MP160
Time Frame
inclusion visit
Title
Score to the Difficulties in Emotion Regulation Scale
Description
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.
Time Frame
inclusion visit
Title
Score to the Beck depression inventory II
Description
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
Time Frame
inclusion visit
Title
Score to the Eating Disorder Questionnaire
Description
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
Time Frame
inclusion visit
Title
Score to the Eating Disorder Inventory
Description
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
Time Frame
inclusion visit
Title
Score to the Childhood trauma questionnaire
Time Frame
inclusion visit
Title
Score to the PTSD Checklist for DSM-5
Time Frame
inclusion visit
Title
Score to the Wisconson Card Sorting Test
Description
We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN
Time Frame
inclusion visit
Title
Score to the Stroop Test
Description
We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN
Time Frame
inclusion visit
Title
Score to the Delay Discounting Test
Description
We aim to assess the link between decision making and psychological trauma in AN
Time Frame
inclusion visit
Title
Score to the Trail Making Test
Description
We aim to assess the link between mental flexibility, visio-spatial attention, processing speed and psychological trauma in AN
Time Frame
inclusion visit
Title
Changes in salivary tryptophan
Description
study changes in salivary tryptophan before and after exposition test
Time Frame
inclusion visit
Title
Changes in salivary kynurenine
Description
study changes in salivary kynurenine before and after exposition test
Time Frame
inclusion visit
Title
Changes in salivary P substance
Description
study changes in salivary P substance before and after exposition test
Time Frame
inclusion visit
Title
Changes in salivary neurokinin-1
Description
study changes in salivary neurokinin-1before and after exposition test
Time Frame
inclusion visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 cardiovascular system Refusal of the patient Be protected by law (tutorship or curatorship). To be deprived of liberty by administrative decision.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastien GUILLAUME, PhD
Phone
+33 4 67 33 82 89
Email
s-guillaume@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maude SENEQUE, MD
Phone
+33 4 67 33 56 63
Email
m-senequehaize@chu-montpellier.fr
Facility Information:
Facility Name
University Hospital, Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien GUILLAUME, PhD

12. IPD Sharing Statement

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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

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