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

NCT04804358 | Terminated

• 1 other identifier: RECHMPL20_0186
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; Psychological Trauma; Heart Rate Variability; Kynurenine; Substance P

Outcome Measures

Primary Outcomes (1)

• 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

  inclusion visit

Secondary Outcomes (20)

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

  inclusion visit

• Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)

  inclusion visit

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

  inclusion visit

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

  inclusion visit

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

  inclusion visit

Study Arms (1)

Anorexic women

OTHER

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.

Behavioral: Exposition Test

Interventions

Exposition Test BEHAVIORAL

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.

Anorexic women

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- 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.
• \- Not having answered "it happened to me" or "I witnessed it" to one of the items of LEC-5

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital, Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Anorexia Nervosa; Psychological Trauma

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 18, 2021
• Study Start: September 17, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)