AzTrials
AzTrials

Anorexia NervosaEOAN-VR-ABMNCT06166355

Improving the Treatment of Anorexia Nervosa in Children Through Virtual Reality Body Exposure

A study testing Attentional Bias Modification Training, VR-based body exposure and Cognitive-behavioral therapy in people with Anorexia Nervosa, run by University of Barcelona at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The age of onset of anorexia nervosa has been progressively decreasing in recent years. Also, the prevalence rates of childhood anorexia in many countries have grown significantly. Read more about this study

Who is it for?
Ages Up to 14 years
Conditions the study is for
Anorexia Nervosa
What is being tested?
Attentional Bias Modification Training, VR-based body exposure and Cognitive-behavioral therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteSpain
Study dates
1 Jul 2024to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Up to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients with a primary diagnosis of anorexia nervosa (DSM-V)
  • Patients below 14 years old
  • Patients with BMI <18.5
  • Subsyndromal patients will also be included

Who cannot join

  • Visual deficits
  • Epilepsy or neuroleptic medication
  • Psychotic disorder
  • Bipolar disorder
  • Medical complications
  • Pregnancy
  • Clinical cardiac arrhythmia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

José Gutiérrez-Maldonado contact

93 312 51 24 ext. +34

jgutierrezm@ub.edu

Marta Ferrer-Garcia contact

667287894 ext. +34

martaferrerg@ub.edu

Spain1 site, 1 recruiting
  • Hospital Sant Joan de Déu

    Barcelona, Barcelona, 08950

    Eduardo Serrano-Troncoso, eduardo.serrano@sjd.es

    Recruiting

Other trials in Spain

About this study

The age of onset of anorexia nervosa has been progressively decreasing in recent years. Also, the prevalence rates of childhood anorexia in many countries have grown significantly. This increase was already observed before the COVID-19 pandemic, but the confinements and the stress derived from them have caused this increase to accelerate. As in adolescent and adult patients, in childhood anorexia some of the core signs and symptoms are an extreme fear of gaining weight and avoidance of food. The consequences of the early-onset of anorexia can be very important since the maturation of the organism is more incomplete in children than in adolescents. Weight loss can have very severe consequences, since in children the percentage of body fat is lower. On the other hand, hormonal disorders derived from food deprivation also have very severe consequences for the development of different organs. General physical development and growth can be affected, with consequences such as not being able to reach normal height. The research carried out to date on the efficacy of treatments for childhood anorexia is very scarce. There are no specific treatment strategies or settings for children with anorexia, and little research has been done to tailor treatment for younger patients. Given the need to explore new treatments for anorexia nervosa specifically aimed at children, the objective of this project is to develop a program to carry out exposure to one's own body through virtual reality, gradually, with progressive increases in size until achieving a healthy weight. In the virtual exposure, patients will observe the image of an avatar in a mirror for the time necessary in each session to produce the reduction of the anxiety response. The avatars that will be developed for this purpose will have a physical constitution corresponding to children under 14 years of age, and physical proportions equivalent to those of each patient. The positive results obtained with a previous version of this treatment originally developed for adolescents and adults suggest that its adaptation to children can open new ways for exploring effective treatments for childhood anorexia.

Read the detailed description

The age of onset of anorexia nervosa (AN) has been progressively decreasing in recent years, and the prevalence of childhood AN has grown significantly. This increase was already observed before the COVID-19 pandemic, but the confinements have caused this increase to accelerate. The incidence of eating disorders (ED) was 15.3% higher in 2020 compared with previous years. The relative risk increased steadily from March 2020 onwards, exceeding 1.5 by the end of the year. The increase was primarily related to teenagers and AN. A higher proportion of patients in 2020 had suicidal ideation or attempted suicide. Although the diagnostic criteria of AN are applied equally regardless of age, there are differential characteristics between child patients and adolescents or adults in the form of presentation, epidemiology, comorbidity and, also, in outcomes. In most studies, an age of less than 14 has been used as a criterion to define the childhood presentation of this disorder, since it coincides with the legal criterion in many countries. The somatic and mental consequences of early-onset anorexia have a strong negative effect on later adult life. Regardless of the treatment applied, only about half of patients maintain their restored weight in the long term. Little research has been done to tailor treatment for younger patients. Therefore, there is an urgent need for studies on new strategies to treat this serious disorder in children. The objective of this project is to develop a program to carry out exposure to one's own body through virtual reality, with progressive increases in the body mass index (BMI). Patients will observe an avatar in a mirror for the time necessary in each session to produce habituation, extinguishing the anxiety response. The avatars will have a physical constitution corresponding to children under 14 years old, and physical proportions equivalent to those of each patient. The results obtained with the version of this treatment originally developed for adolescents and adults by the investigation group suggest that its adaptation to children can open new ways for exploring effective treatments for children AN. It will also be analyzed whether the addition of a component aimed at modifying attentional biases towards the body increases the efficacy of the exposure. The hypothesis is: if a component of virtual-reality body exposure is added to the usual treatment for AN in children, then the treatment will be more effective. Furthermore, if a component designed to reduce body attention bias is also added, then the efficacy of the treatment will be even greater. The efficacy of this treatment, aimed at reducing the fear of gaining weight, will be analyzed in a randomized controlled study in which a group of patients under 14 years of age will receive treatment as usual, another group will receive treatment as usual plus five booster sessions of virtual body exposure, and a third group will receive treatment as usual, plus five booster sessions of virtual body exposure plus modification of attentional biases towards the body.

Being tested
Attentional Bias Modification Training, VR-based body exposure, Cognitive-behavioral therapy
Keywords
Attentional Bias, Virtual Reality, Eye-Tracking, Body exposure procedure, Attentional bias modification training
Medical subject headings
Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attentional Bias Modification TrainingBehavioural

    Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions and five sessions of Attentional Bias Modification Training.

  • VR-based body exposureBehavioural

    Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions

  • Cognitive-behavioral therapyBehavioural

    Usual cognitive-behavioral treatment (CBT) sessions.

Study groups in NCT06166355
Study groupRoleWhat they receive
Cognitive-behavioral therapy plus VR-based body exposure and Attentional Bias Modification Training.ExperimentalIn this group, five sessions of VRE will be added to the usual CBT, as in the other experimental group, but, in addition, at the beginning of each of the exposure sessions, the training aimed at reducing the attentional bias will be carried out. The training will be developed through the visual selection of geometric figures that fit approximately with specific parts of the body. Each of these figures can have different colors. Specifically, the patient must detect and identify the figures that will appear in different parts of the avatar's body. In half of the trials, the shape of the figure must be discriminated and in the remaining 50%, the discrimination will be based on color. Throughout the training, the geometric figures will appear on weight-related body parts in 45% of the trials, and in another 45% of the trials, it will appear on non-weight-related body parts. In the remaining trials (10%), the test will appear on one of three neutral stimuli located next to the avatar.
Receives: Behavioral: Attentional Bias Modification Training; Behavioral: VR-based body exposure; Behavioral: Cognitive-behavioral therapy
Cognitive-behavioral therapy for anorexia and VR-based body exposure:ExperimentalPatients assigned to this group will receive the usual CBT from the clinical unit or the hospital where they are, and additionally, five sessions of VR-based body exposure intervention. In these weekly sessions patients will go through a body exposure intervention in which they will own a virtual avatar with their real measurements, that will progressively increase its BMI values throughout the following exposure sessions until a healthy BMI value is reached.
Receives: Behavioral: VR-based body exposure; Behavioral: Cognitive-behavioral therapy
Cognitive behavioral therapyActive comparatorPatients assigned to this group will receive the usual treatment from the center in which they are recruited for the study (CBT), and will have to complete the evaluations following the same schedule as the experimental group.
Receives: Behavioral: Cognitive-behavioral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) drive for thinness (EDI-DT) scale

    Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness.

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

  2. Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) body dissatisfaction (EDI-BD) scale

    Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction.

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

  3. Change in body mass index values

    Evaluation of change in Body Mass Index values

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

Secondary outcomes (6)
  1. Change in Body Anxiety: Physical Appearance State Anxiety Scale (PASTAS)

    Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

  2. Change in Body image disturbance: Body Appreciation Scale (BAS)

    Evaluation of the change in body appreciation using the BAS, with a scale of possible scores ranging from 13-65, where higher scores indicate higher body appreciation

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

  3. Change in Body image disturbance: Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores

    Evaluation of the change in body distortion using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

  4. Change in Body image disturbance: Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores

    Evaluation of the change in body dissatisfaction using the BIAS-BD body dissatisfaction scores, ranging from -80 to 80, with higher scores indicating higher body dissatisfaction

    Measured: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up

  5. Change in complete fixation time of the gaze towards weight-related body parts

    Evaluation of the attentional bias towards the body using complete fixation time (evaluated in milliseconds) of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias.

    Measured: From pre-assessment to post-assessment after 6 weeks

  6. Change in number of fixations of the gaze towards weight-related body parts

    Evaluation of the attentional bias towards the body using number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias

    Measured: From pre-assessment to post-assessment after 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start1 Jul 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06166355
Sponsor's protocol ID
510/U/2022
Acronym
EOAN-VR-ABM
Status last verified
Apr 2026
First submitted
4 Dec 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including demographic characteristics, clinical variables, and outcome measures, will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Attentional Bias Modification Training, VR-based body exposure and Cognitive-behavioral therapy in people with Anorexia Nervosa, run by University of Barcelona at 1 site in Spain.

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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 Spain. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact José Gutiérrez-Maldonado (93 312 51 24 ext. +34, jgutierrezm@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) drive for thinness (EDI-DT) scale (time frame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up). The study lists 3 primary outcomes in all. 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 8 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in