NCT07353151

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2026Aug 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

November 13, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

Anorexia nervosa (AN)Virtual reality (VR)Eating disordersFood exposureFeasibility studyFood-related anxietyExposure-based interventionSouth London and Maudsley (SLaM)King's College London (KCL)United Kingdom

Outcome Measures

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.

    Baseline to end of Week 1 (5 weekdays)

Secondary Outcomes (11)

  • Recruitment and retention feasibility

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

  • EDE-Q Global Score

    Baseline and end of Week 1

  • EFQ Total Score

    Baseline and end of Week 1

  • FOFM Score

    Baseline and end of Week 1

  • M3VAS Items

    Baseline and end of Week 1

  • +6 more secondary outcomes

Study Arms (1)

OASIS VR + Treatment as Usual (TAU)

EXPERIMENTAL

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

Interventions

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.

OASIS VR + Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 21932282BACKGROUND
  • 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: 37892518BACKGROUND
  • 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: 38366755BACKGROUND
  • 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: 32663934BACKGROUND

Related Links

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hubertus Himmerich, MD, PhD

    South London and Maudsley NHS Foundation Trust; King's College London

    PRINCIPAL INVESTIGATOR
  • Janet Treasure, MD, PhD

    South London and Maudsley NHS Foundation Trust; King's College London

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

January 20, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01