Anorexia Nervosa Clinical Trial
Official title:
Virtual Reality-Based Attention Bias Modification Training for Anorexia Nervosa (AN-VR-ABM)
Anorexia Nervosa (AN) is considered as one of the most severe subtypes of eating disorders (ED), with important medical complications, high mortality rates, and high comorbidity with other disorders, such as anxiety disorders. Likewise, to what happens in anxiety disorders, several studies have suggested the presence of dysfunctional body-related Attentional Bias (AB) in patients with ED and, specifically, in AN patients. Patients with AN tend to focus their attention on their body, in a dysfunctional way, by showing body checking behaviors, and scrutinizing their general appearance and weight-related body parts. This body-related AB has been associated with higher levels of body dissatisfaction, one of the most important risk factors for the development and maintenance of ED. In addition, body-related AB may be responsible for decreasing the effectiveness of body exposure-based treatments used in patients with AN. For this reason, it is necessary to develop new treatment techniques by adding specific components that aim to reduce body-related AB. It has been proposed to include AB modification techniques within the body exposure therapy, as an effective treatment to reduce body-related AB, body dissatisfaction, and body anxiety. To date, our group has been the first, to use a combination of virtual reality (VR) and eye-tracking (ET) techniques to assess the presence of a body-related AB in non-clinical samples. In order to improve AN-based treatments, this project aims to develop a new AB modification procedure, using ET and VR technologies. In addition, this project aims to integrate this AB modification procedure as a part of a body exposure-based treatment that aims to reduce the fear of weight gain experienced by patients with AN. Finally, this project aims to assess whether adding two separate components of body exposure-based therapy and AB modification training would result in a more effective intervention. It is expected that adding a specific component of VR body exposure procedure in the usual treatment for AN, enhanced through the illusion of ownership toward the virtual body, will result in more effective treatment. In addition, it is expected that adding an AB modification training in the body-exposure-based procedure, will result in a further increase the effectiveness of the treatment.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | February 29, 2024 |
Est. primary completion date | February 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Patients with a primary diagnosis of anorexia nervosa (DSM-V) - from the age of 14 years - with BMI <18.5 - subsyndromal patients will also be included, understood as those patients who fulfill all the criteria of anorexia nervosa with the exception of two at most Exclusion Criteria: - visual deficits - epilepsy or neuroleptic medication - psychotic disorder - bipolar disorder - medical complications - pregnancy - clinical cardiac arrhythmia |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Sant Joan de Déu | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona | Hospital San Carlos, Madrid, Hospital Sant Joan de Deu, Hospital Universitari de Bellvitge |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body-related anxiety | Visual analogue scale from 0 to 100, with higher scores indicating higher 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 | |
Other | Fear of gaining weight | Visual analogue scale from 0 to 100, with higher scores indicating higher 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 ] | |
Other | Full body illusion | Visual analogue scale from 0 to 100, with higher scores indicating higher body ownership illusion | Up to 40 minutes. Baseline (prior to beginning the body exposure session) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in number of fixations of the gaze towards weight-related body parts | Evaluation of the attentional bias towards the body using complete fixation time (evaluated in milliseconds) of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias. | From pre-assessment to post-assessment after 6 weeks | |
Secondary | Change in complete fixation time of the gaze towards weight-related body parts | Evaluation of the attentional bias towards the body using number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias | From pre-assessment to post-assessment after 6 weeks . | |
Secondary | Change in complete fixation time of the gaze towards weight-related body parts | Evaluation of the attentional bias towards the body using number of fixations of the gaze towards weight-related body parts, with higher values indicating a greater attentional bias | From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up | |
Secondary | 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 | From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up | |
Secondary | Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores | Evaluation of the change in body dissatisfaction using the BIAS-BD body distortion scores, ranging from -80 to 80, with higher scores indicating higher body distortion | From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up | |
Secondary | Change in 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 | From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up | |
Secondary | Change in 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 | From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up |
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