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

January 19, 2026 updated by: King's College London

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OASIS VR + Treatment as Usual (TAU)
Single-group, open-label feasibility arm. Participants receive a brief virtual reality (VR) program (OASIS) alongside treatment as usual. The VR program is delivered as five supervised sessions over one week (≈20-30 minutes per session) in inpatient, day service, or outpatient settings.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to end of Week 1 (5 weekdays)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months 2-10 (recruitment) and Baseline to end of Week 1 (retention)
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.
Baseline and end of Week 1
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.
Baseline and end of Week 1
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.
Baseline and end of Week 1
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.
Baseline and end of Week 1
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.
Baseline and end of Week 1
Acceptability/usability of VR
Time Frame: End of Week 1
Study-specific 0-10 ratings of acceptability/helpfulness (higher = better); summarized as mean (SD).
End of Week 1
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).
End of Week 1
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.
Baseline and end of Week 1
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.
During sessions through end of Week 1
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.
Baseline and end of Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Hubertus Himmerich, MD, PhD, South London and Maudsley NHS Foundation Trust; King's College London
  • Study Chair: Janet Treasure, MD, PhD, South London and Maudsley NHS Foundation Trust; King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS: 359405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing of de-identified individual participant data (IPD) is under consideration pending sponsor and NHS approvals, information governance review, and repository selection. Aggregate results will be published. An IPD sharing statement will be updated once approvals are in place.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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