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NCT Number: NCT06166355

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

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.

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Key information

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu

Barcelona, 08950, Spain

Location status: Recruiting

Location contact

Eduardo Serrano-Troncoso

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Attentional Bias Modification Training

Behavioral

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 exposure

Behavioral

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

Cognitive-Behavioral Therapy

Behavioral

Usual cognitive-behavioral treatment (CBT) sessions.

Primary outcomes

  1. 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

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

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

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

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

  3. Change in body mass index values

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

    Evaluation of change in Body Mass Index values

Secondary outcomes

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

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

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

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

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

    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

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

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

    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

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

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

    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

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

    Time frame: From pre-assessment to post-assessment after 6 weeks

    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.

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

    Time frame: From pre-assessment to post-assessment after 6 weeks

    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

Other outcomes

  1. Body-related anxiety

    Time frame: Up to 40 minutes. Baseline (prior to beginning the body exposure session), every two minutes during the exposure, and at the end of the body exposure session

    Visual analogue scale from 0 to 100, with higher scores indicating higher body-related anxiety

  2. Fear of gaining weight

    Time frame: Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session

    Visual analogue scale from 0 to 100, with higher scores indicating higher fear of gaining weight

  3. Full body ownership illusion

    Time frame: Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session

    Visual analogue scale from 0 to 100, with higher scores indicating higher full body ownership illusion

Study contacts

Contact information is provided by the study sponsor or research team.

José Gutiérrez-Maldonado

CONTACT

[email protected]

93 312 51 24 ext. +34

Marta Ferrer-Garcia

CONTACT

[email protected]

667287894 ext. +34

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • Hospital Sant Joan de Deu

Registry information

Acronym: EOAN-VR-ABM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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