AN-VR-ABM: Attentional Bias Modification and Body Exposure Using Virtual Reality and Eye-Tracking to Enhance Treatment for Adolescents With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) body dissatisfaction (EDI-BD) scale.
研究概览
简要总结
Anorexia Nervosa (AN) is considered one of the most severe subtypes of eating disorders (EDs), characterized by significant medical complications, high mortality rates, and high comorbidity with other disorders, such as anxiety disorders. Similarly to what occurs in anxiety disorders, several studies have suggested the presence of dysfunctional body-related attentional bias (AB) in patients with EDs, and specifically in patients with AN. Individuals with AN tend to focus their attention on their body in a dysfunctional manner, engaging in body-checking behaviors and excessively scrutinizing their general appearance and weight-related body parts. This body-related AB has been associated with higher levels of body dissatisfaction, which represents one of the most important risk factors for the development and maintenance of EDs.
Moreover, body-related AB may contribute to reducing the effectiveness of body exposure-based treatments used in patients with AN. For this reason, it is necessary to develop new treatment techniques by incorporating specific components aimed at reducing body-related AB. It has been proposed that attentional bias modification techniques could be integrated into body exposure therapy as an effective approach to reduce body-related AB, body dissatisfaction, and body anxiety.
To date, our research group has been the first to use a combination of virtual reality (VR) and eye-tracking (ET) technologies to assess the presence of body-related AB in non-clinical samples. In order to improve treatments for AN, the present project aims to develop a novel attentional bias modification procedure using ET and VR technologies. In addition, this project seeks to integrate this AB modification procedure into a body exposure-based treatment designed to reduce the fear of weight gain experienced by patients with AN.
Finally, the project aims to evaluate whether combining two distinct components-body exposure-based therapy and attentional bias modification training-results in a more effective intervention. It is expected that the inclusion of a VR-based body exposure procedure in standard AN treatment, enhanced through the illusion of ownership over a virtual body, will lead to improved treatment outcomes. Furthermore, it is anticipated that the addition of attentional bias modification training to the body exposure-based procedure will further enhance treatment effectiveness.
详细描述
Attentional bias (AB) refers to the tendency to allocate greater attention to certain types of stimuli or information (e.g., disorder-relevant information) over other types of information. Adolescent patients with Anorexia Nervosa (AN) have been shown to focus more on self-perceived unattractive body parts than on other body parts. Dysfunctional body-related AB is thought to maintain body image disturbances commonly reported by adolescents with AN by selectively processing body-related information that is consistent with dysfunctional cognitive schemas (e.g., "I am getting a fatter belly"), while schema-inconsistent information (e.g., "I am getting thinner") receives less attention and is often visually neglected.
Dysfunctional body-related AB may also contribute to the reduced effectiveness of body exposure-based treatments for adolescents with AN. Therefore, there is a need to develop novel treatment approaches by incorporating specific components aimed at reducing body-related AB in this population. In a previous project conducted by our group, preliminary evidence supported the effectiveness of body-related AB modification in adolescent patients with AN following a virtual reality (VR)-based mirror exposure intervention. A key factor underlying these results may lie in the structure of the procedure, in which patients were required to sequentially focus on different parts of a virtual body (from head to feet) and verbally express their thoughts and emotions related to each body area.
Building on these findings, the present project aims to further advance this line of research by integrating attentional bias modification techniques into body exposure therapy as an effective approach to reducing body-related AB, body dissatisfaction, and body anxiety in adolescents with AN. To date, our research group has been among the first to combine virtual reality (VR) and eye-tracking (ET) technologies to assess body-related AB in both clinical and non-clinical samples. Specifically, this project seeks to determine whether the addition of attentional bias modification training to body exposure-based therapy results in a more effective intervention for adolescents diagnosed with AN.
It is hypothesized that incorporating AB modification training into the body exposure-based procedure (experimental group) will lead to greater treatment efficacy compared with treatment as usual (control group). Specifically, adolescents in the experimental group are expected to show a significant increase in body mass index (BMI) and a significant reduction in core AN symptomatology (e.g., fear of weight gain, body image disturbances), as well as a reduction in body-related AB, from pre- to post-treatment, compared with the control group. These improvements are also expected to be maintained at the six-month follow-up.
The project will be conducted at the Eating Disorders Units of Hospital Sant Joan de Déu (Barcelona, Spain), which specializes in the treatment of adolescents with eating disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adolescents aged 12-17 years.
- •Primary diagnosis of anorexia nervosa according to DSM-5 criteria.
- •Body weight below the expected range for height, age, and sex.
- •Ability to understand and communicate in Spanish.
排除标准
- •Presence of severe mental disorders other than anorexia nervosa.
- •Significant cognitive impairment that would interfere with participation.
- •Visual or auditory deficits that could interfere with VR-based body exposure therapy.
- •Epilepsy.
- •Pregnancy.
- •Cardiac arrhythmia.
结局指标
主要结局
Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) body dissatisfaction (EDI-BD) scale.
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction.
Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) drive for thinness (EDI-DT) scale
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness.
Change in complete fixation time of the gaze towards weight-related body parts
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
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
Change in number of fixations of the gaze towards weight-related body parts
时间窗: From pre-assessment to post-assessment after 6 weeks
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.
Change in Physical Appearance State Anxiety Scale (PASTAS)
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
Fear of gaining weight
时间窗: Up to 40 minutes. Baseline (prior to beginning the body exposure session) and at the end of the body exposure session ]
Visual analogue scale from 0 to 100, with higher scores indicating higher fear of gaining weight
Change in Eating Disorder symptomatology: Eating Disorders Inventory-3 (EDI-3; Garner, 2004) body dissatisfaction (EDI-BD) scale.
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction.
Body-related anxiety
时间窗: 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
Visual analogue scale from 0 to 100, with higher scores indicating higher body-related anxiety
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body dissatisfaction scores
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
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
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
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
Change in body mass index values
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
Evaluation of change in Body Mass Index values
Change in Body Appreciation Scale (BAS)
时间窗: From pre-assessment to post-assessment after 6 weeks , and at the six-month follow-up
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
次要结局
未报告次要终点
研究者
Jose Gutierrez Maldonado
Prof. Dr.
University of Barcelona