Artificial Intelligence-based, Virtual Reality Application to Provide Data- Driven, Patient-centred Treatment for People With Eating Disorders

Обзор

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.

Подробное описание

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.

Participants complete brief assessments at baseline and after the one-week intervention. These include validated self-report measures of eating-disorder symptoms, food-related fear, mood/anxiety, and motivation, plus very short ratings around sessions to track immediate experience (for example, anxiety or relaxation). A subset may take part in a short interview or focus group to describe what felt helpful or difficult and suggest refinements.

There is no randomization or control arm in this feasibility phase. Findings will be used to decide whether and how to run a larger randomized controlled trial, including practical procedures (for example, session dose and outcome burden), expected adherence, safety monitoring steps, and willingness to be randomized.

Вмешательства

• Поведенческое OASIS virtual reality (VR) program
  Immersive VR sessions including (a) food-related exposure scenes, (b) relaxing music, and (c) motivational prompts and goal-setting. Delivered once daily on weekdays for one week (five sessions; ≈20-30 minutes each), supervised by a clinician or trained researcher. Sessions may be paused or stopped at any time.

Первичные конечные точки

• Session adherence to the VR intervention [Срок оценки: Baseline to end of Week 1 (5 weekdays)]

Вторичные конечные точки (11)

• Recruitment and retention feasibility [Срок оценки: Months 2-10 (recruitment) and Baseline to end of Week 1 (retention)]
• EDE-Q Global Score [Срок оценки: Baseline and end of Week 1]
• EFQ Total Score [Срок оценки: Baseline and end of Week 1]
• FOFM Score [Срок оценки: Baseline and end of Week 1]
• M3VAS Items [Срок оценки: Baseline and end of Week 1]
• DASS-42 Total Score [Срок оценки: Baseline and end of Week 1]
• Acceptability/usability of VR [Срок оценки: End of Week 1]
• Willingness outcomes [Срок оценки: End of Week 1]
• Feasibility of assessment battery [Срок оценки: Baseline and end of Week 1]
• Safety (adverse events and VR-related symptoms) [Срок оценки: During sessions through end of Week 1]
• Body Mass Index (BMI) [Срок оценки: Baseline and end of Week 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 < 10.
• Current participation in another research study or clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Cardi V, Krug I, Perpina C, Mataix-Cols D, Roncero M, Treasure J. The use of a nonimmersive virtual reality programme in anorexia nervosa: a single case-report. Eur Eat Disord Rev. 2012 May;20(3):240-5. doi: 10.1002/erv.1155. Epub 2011 Sep 20. PMID 21932282
• Bektas S, Natali L, Rowlands K, Valmaggia L, Di Pietro J, Mutwalli H, Himmerich H, Treasure J, Cardi V. Exploring Correlations of Food-Specific Disgust with Eating Disorder Psychopathology and Food Interaction: A Preliminary Study Using Virtual Reality. Nutrients. 2023 Oct 19;15(20):4443. doi: 10.3390/nu15204443. PMID 37892518
• Natali L, Meregalli V, Rowlands K, Di Pietro J, Treasure J, Collantoni E, Meneguzzo P, Tenconi E, Favaro A, Fontana F, Ceccato E, Sala A, Valmaggia L, Cardi V. Virtual food exposure with positive mood induction or social support to reduce food anxiety in anorexia nervosa: A feasibility study. Int J Eat Disord. 2024 Mar;57(3):703-715. doi: 10.1002/eat.24155. Epub 2024 Feb 17. PMID 38366755
• Young KS, Rennalls SJ, Leppanen J, Mataix-Cols D, Simmons A, Suda M, Campbell IC, O'Daly O, Cardi V. Exposure to food in anorexia nervosa and brain correlates of food-related anxiety: findings from a pilot study. J Affect Disord. 2020 Sep 1;274:1068-1075. doi: 10.1016/j.jad.2020.05.077. Epub 2020 May 25. PMID 32663934

Идентификаторы

NCT: NCT07353151 · IRAS: 359405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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