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临床试验/NCT06795555
NCT06795555招募中不适用

Virtual Food for Real Thought: a Pilot Randomised Controlled Trial of Virtual Reality Exposure in Anorexia Nervosa

University of Padova1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change from baseline to end of intervention in meal related anxiety

研究概览

简要总结

Exposure to food stimuli often elicit aversive emotions in patients with anorexia nervosa, which can perpetuate eating-related avoidance. Exposure therapy has been shown to effectively reduce anxiety toward, and avoidance of, feared stimuli in several psychiatric disorders. Digital technologies, such as virtual reality (VR) have been employed to implement exposure therapy in situations where in vivo exposure is unfeasible, challenging, or perceived as threatening by patients. VR has also the potential to be used by individuals repeatedly in their own time and environment, to consolidate new learning. This pilot randomised controlled study evaluates the feasibility and clinical impact of repeated VR exposure to food stimuli in patients with anorexia nervosa attending intensive daycare treatment (treatment as usual, TAU). VR food exposure will be compared to the use of a relaxation-focused VR scenario (natural environment) and a control condition (no use of VR). Patients in all groups will receive TAU.

详细描述

Patients with anorexia nervosa are recruited from daycare services at Eating Disorder Units in Italy. Inclusion criteria are: (1) current diagnosis of anorexia nervosa according to DSM-5 criteria; (2) 14 years or older. Exclusion criteria are: (1) diagnosis of neurological disorders, (2) diagnosis of psychosis or substance abuse disorders, (3) visual/hearing impairments not corrected by glasses/ear implants; (4) non-tolerance of exposure to VR (i.e., cybersickness, dizziness).

Each patient is randomly assigned to one of three conditions: repeated food exposure in a VR kitchen environment + TAU, repeated exposure to a VR natural setting + TAU, or TAU alone .

VR Food Exposure: Patients in this condition undergo one session of VR exposure in a kitchen environment each day for 5 consecutive days (from Monday, day 1, to Friday, day 5). Each session lasts 5 minutes. The VR environment has been specifically developed by the study team and it was tested in a previous one-session study. The scenario consists of a kitchen with foods of different calorie contents either immediately visible in the environment (for example on a table) or stored in drawings, refrigerators, cabinets. Once in the kitchen, patients can freely move, open the cupboards and the fridge, and grab and hold the foods. Patients are invited to explore the environment and interact with the stimuli they feel most comfortable with. Based on their preference, in each session participants access one of three versions of the virtual kitchen: the virtual kitchen alone, a virtual kitchen + a pink elephant (designed to induce positive mood), or a virtual kitchen + a reassuring voice that encourages to interact with foods and face food-related fears.

VR Nature Exposure: Patients in this condition undergo one session of VR exposure to a natural scenario each day, for 5 consecutive days (from Monday to Friday), through the NatureTreks app. Each session lasts 5 minutes. Participants perform the exposure while seated, and are instructed to observe the environment and try to relax. Based on their preference, in each session participants are able to choose one of three different natural environments: a white sand beach ("Blue Ocean"), a snowy mountain ("White Winter"), or a forest in autumn foliage ("Red Fall")

TAU: It consists of a daycare program (attendance Monday to Friday) including individual psychological therapy (based on cognitive-behavioral principles), nutritional counseling, assisted meals, group activities (e.g., psychotherapy, art therapy, music therapy, relaxation protocols), and psychoeducation for family members. For ethical reasons, at the end of the follow-up assessment, participants in the control group are given the opportunity to engage in VR exposure.

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
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •current diagnosis of anorexia nervosa according to DSM-5 criteria
  • •14 years or older.

排除标准

  • •diagnosis of neurological disorders
  • •diagnosis of psychosis or substance abuse disorders
  • •visual/hearing impairments not corrected by glasses/ear implants
  • •non-tolerance of exposure to VR (i.e., cybersickness, dizziness)

研究组 & 干预措施

Virtual Reality Food Exposure

Experimental

Five sessions of exposure to a virtual kitchen (one session/day, over a week). Participants in this arm will continue receiving treatment as usual for their eating disorder at the treatment center

干预措施: Virtual reality food exposure (Behavioral)

Virtual Reality Nature Exposure

Active Comparator

Five sessions of exposure to a virtual natural environment (one session/day, over a week). Participants in this arm will continue receiving treatment as usual for their eating disorder at the treatment center

干预措施: Virtual Reality Nature Exposure (Behavioral)

Treatment as usual

No Intervention

Patients in this condition will receive treatment as usual only

结局指标

主要结局

Change from baseline to end of intervention in meal related anxiety

时间窗: Measurements at baseline and day 5

Meal related anxiety is assessed on a Likert scale from 0 (no anxiety) to 10 (extreme anxiety)

Feasibility of exposure to the virtual reality environments

时间窗: Following each of five exposure sessions, over a time period of five days

Percentage of participants who interrupt exposure to the virtual reality environment before completion. Discomfort associated to the virtual reality exposure session, rated at the end of each session on a visual analogue scale (0-100).

次要结局

  • Change from baseline to end of intervention in state anxiety(Measurements at baseline and day 5)
  • Change from baseline to end of treatment in positive and negative affect(Measurements at baseline and day 5)
  • Change from baseline to end of intervention in food pictures evaluation(Measurements at baseline and day 5)
  • Effect sizes of changes in anxiety and meal related anxiety from before to after virtual reality exposure(Measurements before and after each exposure session, over five days)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

CARDI VALENTINA

Associate Professor

University of Padova

研究点 (1)

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