The Dialogue Study: A randomized clinical trial evaluating the effectiveness of a virtual reality-based intervention plus treatment as usual versus treatment as usual for eating disorders

BackgroundThere is considerable interest in developing novel psychological interventions for eating disorders targeting characteristics potentially serving as maintaining factors in eating disorder pathology. An estimated 94% of patients with an eating disorder report a dominant internal voice commenting on weight and self-worth, often referred to as the eating disorder voice . The experience of a more dominating eating disorder voice has been linked to longer illness duration. Within psychotic disorders, an intervention termed AVATAR therapy, using computerized avatars, has proven effective in reducing the severity of the psychotic voice and the associated distress. Building on this evidence and the proof-of-concept for AVATAR therapy adapted to eating disorders, this study investigates a modified version of this treatment approach. In this version participants engage with an avatar representing their inner eating disorder voice in immersive virtual reality. MethodsThe study is a randomized parallel-group superiority clinical trial. A total of 96 patients with an eating disorder will be allocated to either seven sessions of virtual reality-based avatar intervention plus treatment as usual (TAU) or TAU. All participants will be assessed at baseline, at treatment cessation (12 weeks), and at 24 weeks post baseline. A stratified block-randomization with concealed randomization sequence will be conducted. DiscussionA case-series study has demonstrated that a non-immersive (2D) application of avatar-based therapy is feasible and acceptable for patients with an eating disorder. While this preliminary evidence is promising, further research is needed to evaluate its efficacy. This current study will be the first investigating this by testing a 3D immersive version of the intervention in a large-scale, methodological rigorous trial. Should the efficacy of this intervention be confirmed, it could open new avenues for research into psychological treatments for eating disorders. Trial registrationClinicalTrials.gov Identifier: NCT06345040 Administrative informationO_ST_ABSTrial registration {2a and 2b}C_ST_ABSH-22067692 and NCT06345040 Protocol version {3}02.04.24, version 1.0. Funding {4}Independent Research Fund Denmark (reference-number: 2096-00078B) Research Fund of the Mental Health services - Capital Region of Denmark. Name and contact information for the trial sponsor {5b}-Independent Research Fund Denmark, Asylgade 7, 5000 Odense C, Denmark, Phone +45 35446800, dff@ufm.dk -Research Fund of the Mental Health Services - Capital Region of Denmark, Kongens Vaenge 2, 3400 Hillerod, Denmark, Phone +45 38665000, pure@regionh.dk Role of sponsor {5c}The sponsors played no part in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.