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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: OASIS VR + Treatment as Usual (TAU)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Session adherence to the VR intervention

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.

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

Secondary outcomes

1

Recruitment and retention feasibility

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

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

EDE-Q Global Score

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.

Time frame
Baseline and end of Week 1
3

EFQ Total Score

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.

Time frame
Baseline and end of Week 1
4

FOFM Score

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.

Time frame
Baseline and end of Week 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: