Health TrialsbyHealthPanel

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

ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 14
SponsorUniversity of Barcelona

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Visual deficits

Epilepsy or neuroleptic medication

Psychotic disorder

Bipolar disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Cognitive-behavioral therapy plus VR-based body exposure and Attentional Bias Modification Training.Experimental treatment 3 interventions
Group B: Cognitive-behavioral therapy for anorexia and VR-based body exposure:Experimental treatment 2 interventions
Group C: Cognitive behavioral therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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

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

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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

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

Other outcomes

1

Body-related anxiety

Visual analogue scale from 0 to 100, with higher scores indicating higher 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
2

Fear of gaining weight

Visual analogue scale from 0 to 100, with higher scores indicating higher 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
3

Full body ownership illusion

Visual analogue scale from 0 to 100, with higher scores indicating higher 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

Sponsors and contacts

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University of Barcelona

Lead sponsor

Hospital Sant Joan de Deu

Collaborator

Source ClinicalTrials.gov
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