Artificial Intelligence-based, Virtual Reality Application to Provide Data- Driven, Patient-centred Treatment for People With Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
研究概览
简要总结
The goal of this clinical trial is to see if a short virtual reality (VR) program can be used safely and comfortably with people receiving care for anorexia nervosa. The study will also check if people are willing to take part and complete the full week of VR sessions.
The main questions the study will answer are:
Can the investigators recruit and keep participants in the study? Do participants complete most of the VR sessions? Do they find the experience helpful and acceptable? Are there any side effects, like nausea or dizziness?
Participants will:
- Take part in one VR session each weekday (about 20 to 30 minutes) for one week
- Continue their usual care during this time
- Answer questions before and after the VR sessions about their anxiety, mood, motivation, and experience
- Some participants may join a short interview or focus group to share feedback
The VR program includes scenes for food-related exposure, calming music, motivational phrases, and goal setting. The app was designed with help from people with lived experience of anorexia and based on psychological therapies used in treatment.
Who can take part:
- Adults aged 18 or older
- People receiving or waiting for care for anorexia nervosa at South London and Maudsley NHS Foundation Trust (SLaM)
- People who are medically stable and able to give informed consent
Why this matters:
This study will help researchers understand if using VR in eating disorder services is practical, safe, and acceptable. The results will help plan a larger trial in the future to see if this type of VR treatment can support recovery from anorexia nervosa. Taking part is voluntary, and participants can stop at any time.
详细描述
This single-site, open-label feasibility clinical trial will test a brief virtual reality (VR) program (OASIS) delivered alongside treatment as usual for adults with anorexia nervosa. OASIS was co-developed by South London and Maudsley NHS Foundation Trust (SLaM), King's College London, and SyncVR Medical UK with input from people with lived experience.
The VR sessions are designed to support recovery by providing:
- Food-related exposure scenes to practise approaching commonly avoided foods
- Relaxing environments with music
- Motivational prompts and goal-setting within the VR experience
Participants complete five supervised VR sessions over one week (about 20-30 minutes each) in inpatient, day service, or outpatient settings. A clinician or trained researcher is present for all sessions. Pacing can be adjusted, and sessions can be paused or stopped at any time.
Feasibility will be assessed using study process measures (for example, recruitment and retention, session completion, and brief usability/acceptability feedback) and session logs. Safety is monitored during every session and via routine clinical information already collected in care; no additional research blood tests are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years.
- •Anorexia nervosa receiving or awaiting treatment as usual (TAU) within South London and Maudsley NHS Foundation Trust (inpatient, day service, or outpatient).
- •Medically stable and clinically suitable to take part in brief VR sessions alongside TAU (as judged by the treating team).
- •Able to give informed consent.
排除标准
- •Current or recent (within 12 months) serious self-harm with suicidal intent, or behaviour that posed a risk to life (e.g., overdose, deep cutting, swallowing sharp objects), or self-harm likely to cause lasting impairment.
- •Active suicidality or high risk of suicide.
- •Untreated or unstable epilepsy.
- •Psychotic disorder.
- •Outpatient participants with BMI <
- •Current participation in another research study or clinical trial.