NCT06166355 Improving the Treatment of Anorexia Nervosa in Children Through Virtual Reality Body Exposure
| NCT ID | NCT06166355 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Barcelona |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2024-07-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
José Gutiérrez-Maldonado
PRINCIPAL INVESTIGATOR
University of Barcelona
Frequently Asked Questions
Who can join the NCT06166355 clinical trial?
This trial is open to participants of all sexes, up to 14 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06166355 currently recruiting?
Yes, NCT06166355 is actively recruiting participants. Contact the research team at jgutierrezm@ub.edu for enrollment information.
Where is the NCT06166355 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06166355 clinical trial?
NCT06166355 is sponsored by University of Barcelona. The principal investigator is José Gutiérrez-Maldonado at University of Barcelona. The trial plans to enroll 108 participants.