Work

Virtual reality-based avatar intervention plus treatment as usual versus treatment as usual for anorexia nervosa and bulimia nervosa: a randomized clinical trial

Year: 2026

Type: preprint

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Interventions for eating disorders increasingly aim to target maintaining psychological mechanisms. One hypothesized mechanism is the internal “eating disorder voice.” In this randomized, parallel-group superiority trial, we evaluated a brief virtual reality (VR)-based psychotherapy enabling interaction with a therapist-operated avatar representing this voice, delivered as an adjunct to treatment as usual (TAU), in adults with anorexia nervosa or bulimia nervosa. Ninety-six participants were randomized 1:1, stratified by TAU recruitment site, with concealed block size, to seven sessions of VR-based avatar intervention + TAU (n=48) or TAU (n=48). Outcomes were assessed at baseline, treatment cessation (12 weeks post baseline), and 24 weeks follow-up. The primary outcome was change in eating disorder symptoms, at treatment cessation measured with the Eating Disorder Examination Questionnaire. The primary analysis showed no statistically significant difference in treatment effect at treatment cessation (adjusted mean difference −0.28 points; 95% CI −0.67 to 0.11; Cohen’s d = −0.33; P = 0.15). However, the intervention showed significant improvement on several prespecified secondary outcomes related to the eating disorder voice and motivation for change, as well as exploratory measures of psychological recovery and quality of life. No serious adverse events related to the intervention were observed. In conclusion, virtual reality-based avatar therapy did not reduce overall eating disorder symptom severity beyond treatment as usual but engaged hypothesized psychological mechanisms of change, supporting its potential role as an adjunctive intervention. ClinicalTrials.gov registration: https://clinicaltrials.gov/study/NCT06345040?term=NCT06345040&rank=1, registration date: 14.03.2024. The study protocol was published in PLOS One (Hansen et al., 2025; https://doi.org/10.1371/journal.pone.0319875). The statistical analysis plan was preregistered on the Open Science Framework (https://osf.io/um638/overview). The study was funded by Independent Research Fund Denmark (reference 2096-00078B) and the Research Fund of the Mental Health Services, Capital Region of Denmark.

Source: Research Square

DOI: 10.21203/rs.3.rs-9856513/v1