Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Eating Disorder Inventory 3
研究概览
简要总结
Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients.
Methods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities.
Primary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone.
Significance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be randomly divided into a control group (Treatment as usual - TAU) and experimental group ( TAU + Virtual Reality intervention).
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: between 16-
- •Primary diagnosis of Anorexia Nervosa
- •BMI > 14.5
- •No current diagnosis or previous diagnosis for neurological disorders
- •Fluency in Italian
- •Ability to provide informed consent (and parental consent for minors)
排除标准
- •Anorexia Nervosa is not a primary diagnosis
- •Age < 16
- •BMI < 14.5
- •Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)
- •Substance abuse, active suicidal ideation, severe psychiatric comorbidities
- •Pregrancy
- •Ongoing participation in other clinical trials
- •Inability to commit to the full duration of the study
研究组 & 干预措施
VR-FME
The VR-FME protocol integrates multiple therapeutic approaches within an immersive virtual environment. Each 60-minute session begins with embodiment induction, where participants experience synchronized multisensory stimulation to create embodiment over their virtual body. Then, various therapeutic techniques - including cognitive dissonance mirror exposure, functionality-focused mirror exposure, and compassionate body scan exercises - will be used. Each of the 8 sessions will work on a specific aspect to address different levels of body image disturbance. The intervention structure begins with an initial assessment and familiarization phase in Week 1, followed by intensive body-focused work in Weeks 2-4.
干预措施: VR -FME (Other)
TAU
For the entire duration of the protocol, both the experimental group (VR-FME) and the control groups will carry out the standard intervention protocol proposed by the treatment center, which consists of an outpatient program that includes weekly internal-nutritional visits, psychotherapy and NPIA assessments to also monitor the pharmacological therapy. Therefore, if the experimental group carries out the standard procedure (Treatment As Usual - TAU) in addition to the VR body image protocol (VR-FME + TAU), the control group will be subjected to the standard treatment path (TAU).
干预措施: VR -FME (Other)
结局指标
主要结局
Eating Disorder Inventory 3
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Eating Disorder Inventory 3 (EDI-3): The EDI-3 is a widely used self-report and standardized measure to assess symptomatology and psychological features relevant to developing and maintaining EDs. The third version (EDI-3) includes 91 items classified into 12 scales, with a six-point Likert scale for each answer ranging from 0 (never) to 5 (always).
Physical Appearance State and Trait Anxiety Scale
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Physical Appearance State and Trait Anxiety Scale (PASTAS): The PASTAS is a reliable and valid measure for the assessment of trait and state body image anxiety. Patients had to rate, on a five-point scale ranging from 0 (never) to 5 (always), if they felt anxious or nervous about their physical appearance, including any tension, negative thoughts, and physiological responses. This tool has been previously used in research studies including Italian samples.
Body Mass Index
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Mass Index (BMI)
Body Image Assessment Scale - Body Dimensions
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
The Body Image Assessment Scale-Body Dimensions (BIAS-BD): The BIAS-BD is used to assess the perceptual and emotional components of BIDs. This test assesses the discrepancy between the perceived body size and the self-determined ideal body size (to measure body dissatisfaction). Furthermore, it also reveals the discrepancy between the perceived body size and the real body size (to measure body distortion). The scale presents a range of 17 silhouettes, with different versions for women and me
Body Appreciation Scale-2
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Appreciation Scale-2 (BAS-2): The BAS-2 is a 10-item measure assessing body appreciation. Participants rate statements on Likert-type scales from 1 (never) to 5 (always). Items are averaged; higher scores indicate greater body appreciation. Example items include: "I respect my body"; "I take a positive attitude towards my body"; and "I am comfortable in my body". This tool has been validated in Italian.
Body Uneasiness Test
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Uneasiness Test (BUT): The BUT is a 34-item self-report questionnaire focusing on body dissatisfaction and body-related emotions such as anxiety, alarm, and embarrassment. It is composed of five subscales - weight phobia, body image concern, avoidance, compulsive self-monitoring, depersonalization - and a general score. This tool has been validated in Italian.
Body Size Estimation Task
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Body Size Estimation Task (BES): it is a behavioral task in which participants are asked to estimate the measure of specific body parts (i.e., shoulders, hips, and waist).
Objectified Body Consciousness Scale
时间窗: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
Objectified Body Consciousness Scale (OBCS): The OBCS contains 24 items grouped into three subscales: body surveillance, body shame, and appearance control beliefs. Each subscale contains eight items, rated on a 7- 7-point Likert-type scale (1 =strongly disagree, 7 = strongly agree). Subscale items are averaged and higher scores indicate a greater manifestation of the particular variable measured. This tool has been validated in Italian.
次要结局
- Qualitative feedback survey(After the end of the intervention (week 4))
研究者
Giulia Brizzi
MSC
Catholic University of the Sacred Heart