Anorexia Nervosa, Feeding and Eating Disorders
Conditions
Keywords
Anorexia nervosa (AN), Virtual reality (VR), Eating disorders, Food exposure, Feasibility study, Food-related anxiety, Exposure-based intervention, South London and Maudsley (SLaM), King's College London (KCL), United Kingdom
Brief summary
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.
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.
Interventions
BEHAVIORALOASIS 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.
Sponsors
King's College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-group, open-label feasibility design. All participants receive the OASIS VR add-on alongside treatment as usual across inpatient, day service, or outpatient settings. The intervention consists of five supervised sessions over one week (≈20-30 minutes each). No randomization or control arm in this phase; focus is on feasibility, acceptability, adherence, and safety.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Session adherence to the VR intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Recruitment and retention feasibility | 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. |
| EDE-Q Global Score | 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. |
| EFQ Total Score | 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. |
| FOFM Score | 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. |
| M3VAS Items | 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. |
| DASS-42 Total Score | 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. |
| Acceptability/usability of VR | End of Week 1 | Study-specific 0-10 ratings of acceptability/helpfulness (higher = better); summarized as mean (SD). |
| Willingness outcomes | 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). |
| Feasibility of assessment battery | 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. |
| Safety (adverse events and VR-related symptoms) | During sessions through end of Week 1 | Counts/types of adverse events (including nausea, dizziness, headache); % of participants with ≥1 event. |
| Body Mass Index (BMI) | 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. |
Contacts
CONTACTWafa A Alharbi
PRINCIPAL_INVESTIGATORHubertus Himmerich, MD, PhD
South London and Maudsley NHS Foundation Trust; King's College London
STUDY_CHAIRJanet Treasure, MD, PhD
South London and Maudsley NHS Foundation Trust; King's College London
Outcome results
None listed