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

NCT ID: NCT04804358

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2021-10-29

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Exposition Test

Intervention Type: 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.

Interventions

Exposition Test

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0186

Identifier Type: -

Identifier Source: org_study_id