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Anorexia Nervosa, Evaluation and MOdification of Attention (ANEMA)

1. Oktober 2026 aktualisiert von: Lille University

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

15 Jahre bis 35 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).

Schein-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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Attentional bias towards food
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Interoceptive abilities
Zeitfenster: 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).
Cardiac activity
Zeitfenster: 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
Autonomic reactivity to food stimuli
Zeitfenster: 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
Psychometric outcomes
Zeitfenster: visits 1 and 2

Psychometric outcomes, measured through validated questionnaires administered before and after the ABMT interventions (visits 1 and 2).

  • Eating disorders symptoms, EDE-Q (Eating Disorder Examination Questionnaire). EDE-Q score is calculated by adding the score of each of the items.
  • Depression, Anxiety, and Stress levels, DASS-42 (Depression, Anxiety, Stress, Scale - 42 items). DASS-42 score is calculated by adding the score of each of the items.
  • Body image and body shape concerns, BSQ (Body Shape Questionnaire). BSQ score is calculated by adding the score of each of the items.
  • Emotional regulation difficulties, DERS-SF (Difficulties in Emotional Regulation - Short Form). DERS-SF score is calculated by adding the score of each of the items.
visits 1 and 2
Electrodermal activity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Depression, Anxiety, and Stress levels
Zeitfenster: 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)
Body image and body shape concerns
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Oktober 2026

Zuerst gepostet (Tatsächlich)

6. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • D2025-8

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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