Clinical trial NCT04028635: Treating the Fear of Gaining Weight in Anorexia Nervosa
Official title: Treating the Fear of Gaining Weight. A Randomized Controlled Clinical Trial for Patients With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
name: Hospital Clinic of Barcelona
name: Hospital San Carlos, Madrid
name: Hospital Universitari de Bellvitge
name: Istituto Auxologico Italiano
First posted: 2019-07-22
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to develop a virtual reality (VR) embodiment-based exposure technique to improve the treatment of anorexia nervosa (AN). A systematic and hierarchical body exposure intervention in which the patient owns a virtual avatar is proposed. At first, the virtual body matches with the real measurements of the patient, then the experimenter will progressively increase Body Mass Index (BMI) values of the virtual body during the exposure sessions until a healthy BMI value is reached (e.g. BMI score of 20). In this study a VR embodiment-based technique that combines visuo-motor and a visuo-tactile stimulation procedures is proposed in order to increase illusory feelings of ownership over the virtual body. It is hypothesised that adding a VR-based body exposure intervention to the classical cognitive behavioral therapy (CBT) will significantly reduce symptomatology in AN patients.

Detailed description: In order to evaluate the efficacy of the addition of a VR body exposure component to the usual treatment, a randomized controlled clinical trial will be conducted. 54 patients with a primary diagnosis of anorexia nervosa and a BMI \> 18.5 will be randomly assigned to the experimental group receiving VR body exposure in addition to cognitive behavioral therapy or control group, which receives cognitive behavioral therapy only. Data regarding eating disorder symptomatology and body related attention will be collected before and at the end of the intervention, as well as after six months of follow-up. In the systematic and hierarchical VR body exposure intervention, which consists of 5 weekly exposure sessions, patients will gradually be exposed to increases in the BMI of their virtual avatar. Each session starts by inducing illusory feelings of ownership over the virtual body by the means of visuo-tactile and visuo-motor stimulation. Then patients are exposed to their virtual bodies in order to achieve the habituation or extinction of the anxiety response to their body image and, consequently, reduce the fear of gaining weight. During exposure, patients will be asked to focus on different parts of the virtual body, by asking what they think and feel about them. Body ownership illusion, body-related anxiety and fear of gaining weight will be assessed within each session by means of visual analogue scales.

Eligibility criteria: Inclusion Criteria:

* patients with primary diagnosis of anorexia nervosa (DSM-V)
* from the age of 14 years
* with BMI \<18.5

Exclusion Criteria:

* visual deficits
* epilepsy or neuroleptic medication
* psychotic disorder
* bipolar disorder
* medical complications
* pregnancy
* clinical cardiac arrhythmia

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Change in Silhouette Test for Adolescents (TSA) body distortion scores
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Change in Physical Appearance State Anxiety Scale (PASTAS)
timeFrame: from pre-assessment to post-assessment after 6 weeks
measure: Change in Body Appreciation Scale (BAS)
timeFrame: from pre-assessment to post-assessment after 6 weeks
Secondary outcomes:
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: Body ownership illusion
timeFrame: Baseline (prior to beginning the body exposure session)
Locations:
city: Barcelona
country: Spain
facility: Universitat de Barcelona
Study officials:
affiliation: University of Barcelona
name: José Gutiérrez-Maldonado, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: