Anorexia Nervosa, Evaluation and MOdification of Attention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-35
SponsorLille University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Attentional Bias Modification Training
Other interventionOne 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).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Training group (TR group)Experimental treatment 1 intervention
Group B: Control group (CT group)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Attentional bias towards food
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.
Time frame
Measured before and after the ABMT intervention (Baseline and week 4).Secondary outcomes
1
Interoceptive abilities
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.
Time frame
Measured before and after the ABMT intervention (Baseline and week 4).2
Cardiac activity
Cardiac activity, measured via an electrocardiogram, with two electrodes placed on the wrists. It is measured through heart rate (in beats per minute).
Time frame
Baseline and week 43
Autonomic reactivity to food stimuli
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).
Time frame
visits 1 and 24
Psychometric outcomes
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.
Time frame
visits 1 and 2Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lille University
Lead sponsor
Groupement des Hôpitaux de l'Institut Catholique de Lille
Collaborator
Source ClinicalTrials.gov
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