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NCT Number: NCT07353151

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

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

OASIS virtual reality (VR) program

Behavioral

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.

Primary outcomes

  1. Session adherence to the VR intervention

    Time frame: Baseline to end of Week 1 (5 weekdays)

    Proportion of scheduled VR sessions completed per participant, recorded from session logs. A session counts as completed if ≥20 minutes are delivered. Primary endpoint = % of participants who complete ≥4 of 5 sessions; the investigators will also report mean (SD) sessions completed.

Secondary outcomes

  1. Recruitment and retention feasibility

    Time frame: Months 2-10 (recruitment) and Baseline to end of Week 1 (retention)

    Recruitment = % of eligible approached who consent. Retention = % of consented who complete the 1-week assessment.

  2. EDE-Q Global Score

    Time frame: Baseline and end of Week 1

    Change in global score on the Eating Disorder Examination Questionnaire (EDE-Q) from baseline to end of Week 1. Score (0-6); higher scores indicate greater severity of eating disorder symptoms.

  3. EFQ Total Score

    Time frame: Baseline and end of Week 1

    Change in total score on the Eating and Food Questionnaire (EFQ) from baseline to end of Week 1.

    Units: Score (0-50); higher scores indicate more maladaptive eating behaviors.

  4. FOFM Score

    Time frame: Baseline and end of Week 1

    Change in score on the Fear of Food Measure (FOFM) from baseline to end of Week 1.

    Units: Score (0-40); higher scores indicate greater food-related anxiety.

  5. M3VAS Items

    Time frame: Baseline and end of Week 1

    Change in visual analog scale ratings (M3VAS) for mood and anxiety from baseline to end of Week 1.

    Units: Score (0-100 mm); higher scores indicate greater symptom severity.

  6. DASS-42 Total Score

    Time frame: Baseline and end of Week 1

    Change in total score on the Depression Anxiety Stress Scales (DASS-42) from baseline to end of Week 1. Units: Score (0-126); higher scores indicate greater psychological distress.

  7. Acceptability/usability of VR

    Time frame: End of Week 1

    Study-specific 0-10 ratings of acceptability/helpfulness (higher = better); summarized as mean (SD).

  8. Willingness outcomes

    Time frame: End of Week 1

    (a) Willingness to try foods encountered in VR outside sessions (four 0-10 items: willingness, readiness, confidence, 1-week likelihood); (b) willingness to participate in a future randomized trial (Yes/No).

  9. Feasibility of assessment battery

    Time frame: Baseline and end of Week 1

    Completion rates across all planned questionnaires; instruments with >25% missing at either time point flagged as infeasible for a future trial.

  10. Safety (adverse events and VR-related symptoms)

    Time frame: During sessions through end of Week 1

    Counts/types of adverse events (including nausea, dizziness, headache); % of participants with ≥1 event.

  11. Body Mass Index (BMI)

    Time frame: Baseline and end of Week 1

    Change in body mass index (BMI) from baseline to end of Week 1. Units: kg/m²; higher values indicate higher body mass.

Study contacts

Contact information is provided by the study sponsor or research team.

Wafa A Alharbi

CONTACT

[email protected]

+447404450403

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Acronym: OASIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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