Anorexia Nervosa, Evaluation and MOdification of Attention (ANEMA)
Anorexia Nervosa, Evaluation and MOdification of Attention (Anorexie Mentale, évaluation et Modification de l'Attention ; le Titre Est dès le départ en Anglais, Mais voilà la Traduction au Cas où Ils Demandent)
Anorexia nervosa (AN), characterized by abnormally low weight, a significant fear of gaining weight, and impaired body perception, is a psychopathological disorder with a 1% prevalence. This disorder has particularly high relapse and mortality rates, highlighting the need for improved patient care. Indeed, patients are often hospitalized, which cuts them off from their environment and contributes to the high risk of post-hospitalization. It therefore seems essential to develop intervention tools that can be used in daily life, to continue treatment in a self-reliant way outside the hospital. Several factors contributing to the maintenance of AN were identified in the literature, including an attentional bias away from food cues. We can also mention a deficit of interoceptive awareness (i.e. low awareness of one's own bodily signals), as well as higher levels of anxiety than in the general population. Physiological dysfunction has also been observed, both at rest and when exposed to food stimuli. Acting on these aspects has led to clinical improvement in several disorders, including anxiety and alcohol use disorder. Given these elements, the investigators propose the implementation of attentional bias modification training in patients suffering from AN. Attentional bias modification training's first aim would be the reduction of food avoidance, while secondary hypotheses postulate that the intervention could have an effect on interoceptive abilities and physiological functioning. This intervention, which can be used by patients themselves, has also shown its effectiveness in reducing anxiety. A reduction in anorexic symptoms and prognosis improvement is expected.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Clinical criteria of anorexia nervosa (AN) include an abnormally low weight due to severe dietary restrictions, an intense fear of gaining weight, and an alteration of body perception, characterized by the tendency to see oneself as larger than they really are. Cognitive theories of psychopathology describe cognitive factors as potential factors influencing disorders' development and maintenance. Those factors include attentional alterations, with an impaired attentional processing of food stimuli on anorexia nervosa. The literature on the subject yields heterogeneous results, but most recent articles using eye-tracking methodologies suggest an attentional avoidance of food stimuli, especially when the presented stimuli are highly caloric. In contrast, individuals from the general population exhibit an attentional bias towards food. Authors postulate that as food is necessary for survival, it is viewed as a positive and motivational stimulus, which could explain this bias. However, in anorexia nervosa, authors suggest that food could be viewed as threatening, as it would participate to weight gain, therefore explaining the attentional avoidance of food found in patients with AN. Some researchers postulated that acting on this attentional bias could be beneficial for patients with AN, and that this could be achieved via attentional bias modification training using a dot-probe task. In this paradigm, participants are exposed to a pair of pictures consisting of a food and a non-food pictures, with one of them being replaced by a probe (letter E or F) that participants have to identify as quickly and as accurately as possible. In an intervention aiming to decrease attentional avoidance of food, the probe would appear at the location of the food picture in majority of the trials, in order to bring participants to orient their attention towards food pictures, therefore reducing its avoidance. In the present study, this intervention is completed at home, with two weekly sessions during four weeks. This choice was made in order to bring patients new therapeutic tools without making their hospital stay longer. Indeed, staying at the hospital longer can isolate patients from their daily environment and make the transition back to this environment more difficult, increasing the risk of relapse. Moreover, by completing their sessions at home and on their own, patients become more independent, which could result in higher self-efficiency feelings and perception.
The intervention is hypothesized to have secondary effects on interoceptive abilities, as some authors suggest a link between attentional biases and interoception. Effects on autonomic functioning are also postulated, as attentional bias modification training has been found to have an effect on electrodermal activity in the general population. As patients with AN have been found to have impaired autonomic functions and interoceptive abilities, these secondary effects would also be beneficial to patients.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Diagnosis of anorexia nervosa (diagnosis made according to DSM-5 criteria)
- Outpatient care as part of the management of anorexia nervosa
- Be female
- Be between the ages of 15 and 35
- Having normal or corrected vision
- Fluency in French
- Having a BMI between 14 and 18 kg/m²
- Having a computer and internet access at home
Exclusion Criteria:
- History of neurologic or cardiovascular disorders
- Medical treatment primarily targeting the cardiovascular system
- Presence of an element requiring specific care other than anorexia nervosa
- Diagnosis on an eating disorder other than anorexia nervosa
- Inability to give informed consent
- Pregnant or nursing woman
- Under guardianship
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Training group (TR group)
completion of ABMT sessions aiming to decrease attentional avoidance of food. In a modified dot-probe task with pairs of food and non-food stimuli, the probe appears at the location of the food stimulus in 90% of the trials, aiming to focus participants' attention on those stimuli. |
One group, labelled as "experimental group (TR group)", receives an attentional bias modification training (ABMT) which aims to decrease avoidance of food by focusing attention on food stimuli, while the other group, labelled as "control group (CT group)" receives a sham ABMT, which acts as a control and does not aim to modify attentional orientation. Both groups complete eight at-home sessions consisting of dot-probe task trials. In the TR group, the probe appears at the location of the food stimulus in 90% of trials (in order to orient participants' attention towards those stimuli), while in the CT group, the probe appears randomly and with equal probability behind the food or non-food stimulus in all trials (classic dot-probe task). |
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Pozorny komparator: Control group (CT group)
completion of ABMT sessions not aiming to modify attentional orientation. In a classic dot-probe task with pairs of food and non-food stimuli, the probe appears at the location of the food stimulus or the non-food stimulus randomly and with equal probability across trials. |
One group, labelled as "experimental group (TR group)", receives an attentional bias modification training (ABMT) which aims to decrease avoidance of food by focusing attention on food stimuli, while the other group, labelled as "control group (CT group)" receives a sham ABMT, which acts as a control and does not aim to modify attentional orientation. Both groups complete eight at-home sessions consisting of dot-probe task trials. In the TR group, the probe appears at the location of the food stimulus in 90% of trials (in order to orient participants' attention towards those stimuli), while in the CT group, the probe appears randomly and with equal probability behind the food or non-food stimulus in all trials (classic dot-probe task). |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Attentional bias towards food
Ramy czasowe: Measured before and after the ABMT intervention (Baseline and week 4).
|
Attentional bias towards food, measured with reaction times (measured in milliseconds) and accuracy of responses, during a dot-probe and an ARDPEI tasks. The combination of the two for each type of stimuli allow for the calculation of a Speed-Accuracy Composite Score (SACS, no unit of measure) for both food and non-food stimuli. An attentional bias towards food score is then obtained by subtracting the SACS obtained when the probe appears at the location of the non-food picture to the SACS obtained when the probe appears at the location of the food picture. |
Measured before and after the ABMT intervention (Baseline and week 4).
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Interoceptive abilities
Ramy czasowe: Measured before and after the ABMT intervention (Baseline and week 4).
|
Attentional bias towards food, measured with fixation time and saccade latency (measured in milliseconds), during a dot-probe and an ARDPEI tasks. An attentional bias towards food score is then calculated by subtracting fixation time and saccade latency when the probe appears at the location of the non-food picture to the fixation time and saccade latency when the probe appears at the location of the food picture. |
Measured before and after the ABMT intervention (Baseline and week 4).
|
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Cardiac activity
Ramy czasowe: Baseline and week 4
|
Cardiac activity, measured via an electrocardiogram, with two electrodes placed on the wrists. It is measured through heart rate (in beats per minute). |
Baseline and week 4
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Autonomic reactivity to food stimuli
Ramy czasowe: visits 1 and 2
|
Autonomic reactivity to food stimuli, measured via an EKG for cardiac reactivity, a respiratory belt for respiratory reactivity, and electrodes placed on participants' fingers for electrodermal reactivity. Measured before and after the ABMT interventions (visits 1 and 2). |
visits 1 and 2
|
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Psychometric outcomes
Ramy czasowe: visits 1 and 2
|
Psychometric outcomes, measured through validated questionnaires administered before and after the ABMT interventions (visits 1 and 2).
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visits 1 and 2
|
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Electrodermal activity
Ramy czasowe: Measured before and after the ABMT intervention (Baseline and week 4).
|
Electrodermal activity, measured via electrodes specifically designed to measure electrodermal activity, placed on the non-dominant hand's index and major. It is measured through amplitude of skin conductance response (μS). |
Measured before and after the ABMT intervention (Baseline and week 4).
|
|
Respiratory activity
Ramy czasowe: Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
3) Respiratory activity, measured via a respiratory belt placed on the sternum. It is measured through respiratory frequency (cycles per minute) |
Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
|
Cutaneous temperature
Ramy czasowe: Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
Cutaneous temperature, measured via an electrode specifically designed to measure cutaneous temperature places on the non-dominant hand's ring finger. It is measured through the finger's temperature (in Celsius degrees). |
Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
|
Eating disorders symptoms
Ramy czasowe: Measured before and after the ABMT intervention (Baseline and week 4)
|
Eating disorders symptoms, measured via the Eating Disorder Examination - Questionnaire (EDE-Q), which gives a score between 0 and 132, with a higher score meaning more severe eating disorders symptoms (worse outcome). The score is calculated by summing the items' score together. |
Measured before and after the ABMT intervention (Baseline and week 4)
|
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Depression, Anxiety, and Stress levels
Ramy czasowe: Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
Depression, Anxiety, and Stress levels, measured via the Depression, Anxiety, Stress scale - 42 items (DASS-42), which gives a score between 0 and 126, with a higher score meaning higher levels of depression, anxiety, and stress (worse outcome). The score is calculated by summing the items' score together. |
Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
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Body image and body shape concerns
Ramy czasowe: Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
Body image and body shape concerns, measured via the Body Shape Questionnaire (BSQ), which gives a score between 34 and 204, with a higher score meaning more body image and body shape concerns (worse outcome). The score is calculated by summing the items' score together. |
Time Frame: Measured before and after the ABMT intervention (Baseline and week 4)
|
|
Emotional regulation difficulties
Ramy czasowe: Measured before and after the ABMT intervention (Baseline and week 4)
|
Emotional regulation difficulties, measured via the Difficulties with Emotional Regulation Scale - Short Form (DERS-SF) which gives a score between 18 and 90, with a higher score meaning greater emotional regulation difficulties (worse outcome). The score is calculated by summing the items' score together. |
Measured before and after the ABMT intervention (Baseline and week 4)
|
|
Interoceptive sensibility
Ramy czasowe: Measured before and after the ABMT intervention (Baseline and week 4)
|
Interoceptive sensibility, measured via the Multidimensional Assessment of Interoceptive Awareness (MAIA), which gives a score between 0 and 160, with a higher score meaning greater interoceptive sensibility (better outcome). The score is calculated by summing the items' score together. |
Measured before and after the ABMT intervention (Baseline and week 4)
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- D2025-8
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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