Treating the Fear of Gaining Weight. A Randomized Controlled Clinical Trial for Patients With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary diagnosis of anorexia nervosa (DSM-V)
- •from the age of 14 years
- •with BMI <18.5
排除标准
- •visual deficits
- •epilepsy or neuroleptic medication
- •psychotic disorder
- •bipolar disorder
- •medical complications
- •pregnancy
- •clinical cardiac arrhythmia
结局指标
主要结局
Change in Eating Disorders Inventory-3 (EDI-3) drive for thinness (EDI-DT) scale
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in drive for thinness, with maximum possible score of 28, where higher scores indicate higher drive for thinness
Change in Body Mass Index
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of change in Body Mass Index
Change in Eating Disorders Inventory-3 (EDI-3) body dissatisfaction (EDI-BD) scale
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction, with maximum possible score of 40, where higher scores indicate higher body dissatisfaction
Change in Silhouette Test for Adolescents (TSA) body distortion scores
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body distortion in adolescents using the TSA body distortion scores, which can range from -3 to 3, with higher values indicating higher body distortion
Change in Silhouette Test for Adolescents (TSA) body dissatisfaction scores
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction in adolescents using the TSA body dissatisfaction scores, which can range from -3 to 3, with lower scores indicating higher body dissatisfaction
Figural Drawing Scale for Body Image Assessment (BIAS-BD) body distortion scores
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body distortion in adults 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 dissatisfaction scores
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of the change in body dissatisfaction in adults using the BIAS-BD body dissatisfaction scores, ranging from -80 to 80, with higher scores indicating higher body dissatisfaction
Change in Physical Appearance State Anxiety Scale (PASTAS)
时间窗: from pre-assessment to post-assessment after 6 weeks
Evaluation of body-related anxiety using the PASTAS, with a maximum score of 32, with higher scores indicating higher body-related anxiety
Change in Body Appreciation Scale (BAS)
时间窗: from pre-assessment to post-assessment after 6 weeks
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
- Change in complete fixation time of the gaze towards weight-related body parts(from pre-assessment to post-assessment after 6 weeks)
- Change in number of fixations of the gaze towards weight-related body parts(from pre-assessment to post-assessment after 6 weeks)
研究者
Jose Gutierrez Maldonado
Full Professor
University of Barcelona