Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07353151

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
45 (estimated)
Sponsor
King's College London · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALOASIS virtual reality (VR) programImmersive 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.

Timeline

Start date
2026-01-01
Primary completion
2027-08-01
Completion
2027-08-01
First posted
2026-01-20
Last updated
2026-01-21

Source: ClinicalTrials.gov record NCT07353151. Inclusion in this directory is not an endorsement.