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

NCT06166355 | Recruiting

• 1 other identifier: 510/U/2022
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Attentional Bias; Virtual Reality; Eye-Tracking; Body exposure procedure; Attentional bias modification training

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• Change in body mass index values

  Evaluation of change in Body Mass Index values

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

Secondary Outcomes (6)

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

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

• Change in Body image disturbance: Body Appreciation Scale (BAS)

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

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

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

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

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

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

  From pre-assessment to post-assessment after 6 weeks

Other Outcomes (3)

• Body-related anxiety

  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

• Fear of gaining weight

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

• Full body ownership illusion

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

Study Arms (3)

Cognitive-behavioral therapy plus VR-based body exposure and Attentional Bias Modification Training.

EXPERIMENTAL

In 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.

Behavioral: Attentional Bias Modification Training; Behavioral: VR-based body exposure; Behavioral: Cognitive-behavioral therapy

Cognitive-behavioral therapy for anorexia and VR-based body exposure:

EXPERIMENTAL

Patients 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.

Behavioral: VR-based body exposure; Behavioral: Cognitive-behavioral therapy

Cognitive behavioral therapy

ACTIVE COMPARATOR

Patients 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.

Behavioral: Cognitive-behavioral therapy

Interventions

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.

Cognitive-behavioral therapy plus VR-based body exposure and 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 for anorexia and VR-based body exposure:; Cognitive-behavioral therapy plus VR-based body exposure and Attentional Bias Modification Training.

Cognitive-behavioral therapy BEHAVIORAL

Usual cognitive-behavioral treatment (CBT) sessions.

Cognitive behavioral therapy; Cognitive-behavioral therapy for anorexia and VR-based body exposure:; Cognitive-behavioral therapy plus VR-based body exposure and Attentional Bias Modification Training.

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sant Joan de Deu: collaborator
• University of Barcelona: lead

Study Sites (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• José Gutiérrez-Maldonado

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Gutiérrez-Maldonado

CONTACT

93 312 51 24; jgutierrezm@ub.edu

Marta Ferrer-Garcia

CONTACT

667287894; martaferrerg@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)