Clinical trial NCT06166355: Improving the Treatment of Anorexia Nervosa in Children Through Virtual Reality Body Exposure
Official title: Improving the Treatment of Anorexia Nervosa in Children Through Virtual Reality Body Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Attentional Bias
Virtual Reality
Eye-Tracking
Body exposure procedure
Attentional bias modification training
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
First posted: 2023-12-12
Enrollment: 108
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) drive for thinness (EDI-DT) scale
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
measure: Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) body dissatisfaction (EDI-BD) scale
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
measure: Change in body mass index values
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
Secondary outcomes:
measure: Change in Body Anxiety: Physical Appearance State Anxiety Scale (PASTAS)
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
measure: Change in Body image disturbance: Body Appreciation Scale (BAS)
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
measure: Change in Body image disturbance: Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
measure: Change in Body image disturbance: Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
timeFrame: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
measure: Change in complete fixation time of the gaze towards weight-related body parts
timeFrame: From pre-assessment to post-assessment after 6 weeks
measure: Change in number of fixations of the gaze towards weight-related body parts
timeFrame: From pre-assessment to post-assessment after 6 weeks
Other outcomes:
measure: Body-related anxiety
timeFrame: 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
measure: Fear of gaining weight
timeFrame: Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session
measure: Full body ownership illusion
timeFrame: Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
affiliation: University of Barcelona
name: José Gutiérrez-Maldonado
role: PRINCIPAL_INVESTIGATOR
References: