Anorexia NervosaATACNCT04804358
Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors
A study testing Exposition Test in people with Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Exposition Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2021to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Refusal of the patient
- Be protected by law (tutorship or curatorship).
- To be deprived of liberty by administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Exposition Test
- Keywords
- anorexia nervosa, Psychological Trauma, Heart Rate Variability, Kynurenine, Substance P
- Medical subject headings
- Anorexia Nervosa, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposition TestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exposition Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: inclusion visit
Secondary outcomes (20)
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
Measured: inclusion visit
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
Measured: inclusion visit
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
Measured: inclusion visit
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
Measured: inclusion visit
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
Measured: inclusion visit
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
Measured: inclusion visit
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.
Measured: inclusion visit
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
Measured: inclusion visit
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
Measured: inclusion visit
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
Measured: inclusion visit
Score to the Childhood trauma questionnaire
Measured: inclusion visit
Score to the PTSD Checklist for DSM-5
Measured: inclusion visit
Score to the Wisconson Card Sorting Test
We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN
Measured: inclusion visit
Score to the Stroop Test
We aim to assess the link between mental flexibility, working memory, inhibition and psychological trauma in AN
Measured: inclusion visit
Score to the Delay Discounting Test
We aim to assess the link between decision making and psychological trauma in AN
Measured: inclusion visit
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
Measured: inclusion visit
Changes in salivary tryptophan
study changes in salivary tryptophan before and after exposition test
Measured: inclusion visit
Changes in salivary kynurenine
study changes in salivary kynurenine before and after exposition test
Measured: inclusion visit
Changes in salivary P substance
study changes in salivary P substance before and after exposition test
Measured: inclusion visit
Changes in salivary neurokinin-1
study changes in salivary neurokinin-1before and after exposition test
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start17 Sep 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Why it stopped: The person in charge of the clinical study had to leave the hospital prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804358
- Sponsor's protocol ID
- RECHMPL20_0186
- Acronym
- ATAC
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2021
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04804358
- Acronym / sponsor ID
- ATAC / RECHMPL20_0186
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, Psychological Trauma, Heart Rate Variability, Kynurenine, Substance P
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The person in charge of the clinical study had to leave the hospital prematurely.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anorexic women | Other | Behavioral: Exposition 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposition TestDuring 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. | Behavioural | Anorexic women |
Primary outcome
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)
Time frame: 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
20 secondary outcomes
Changes in low frequency heart variability (LF-HRV) across the exposition test (before, during and after)
Time frame: inclusion visit
Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)
Time frame: inclusion visit
Changes in the highest peak of the high frequency (HFhz) across the exposition test (before, during and after)
Time frame: inclusion visit
Changes in the interval between R peaks (R-R across the exposition test (before, during and after)
Time frame: inclusion visit
Changes in the R-R interval standard difference (STD-RR) across the exposition test (before, during and after)
Time frame: inclusion visit
Changes in the root mean successive squared differences of the R-R interval (RMSSD). across the exposition test (before, during and after)
Time frame: inclusion visit
Score to the Difficulties in Emotion Regulation Scale
Time frame: inclusion visit
Score to the Beck depression inventory II
Time frame: inclusion visit
Score to the Eating Disorder Questionnaire
Time frame: inclusion visit
Score to the Eating Disorder Inventory
Time frame: inclusion visit
Score to the Childhood trauma questionnaire
Time frame: inclusion visit
Score to the PTSD Checklist for DSM-5
Time frame: inclusion visit
Score to the Wisconson Card Sorting Test
Time frame: inclusion visit
Score to the Stroop Test
Time frame: inclusion visit
Score to the Delay Discounting Test
Time frame: inclusion visit
Score to the Trail Making Test
Time frame: inclusion visit
Changes in salivary tryptophan
Time frame: inclusion visit
Changes in salivary kynurenine
Time frame: inclusion visit
Changes in salivary P substance
Time frame: inclusion visit
Changes in salivary neurokinin-1
Time frame: inclusion visit
Results and safety
The study was stopped early (reason given: The person in charge of the clinical study had to leave the hospital prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposition Test in people with Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The person in charge of the clinical study had to leave the hospital prematurely.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after) (time frame: inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.