nctId: NCT06345040 id: H-22067692 briefTitle: The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders overallStatus: RECRUITING date: 2024-02-26 date: 2025-12 date: 2026-06 date: 2024-04-03 date: 2024-04-03 name: Mental Health Services in the Capital Region, Denmark class: OTHER briefSummary: The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles. conditions: Eating Disorders conditions: Anorexia Nervosa conditions: Bulimia Nervosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Virtual-reality intervention name: TAU - specialized treatment measure: Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire measure: Level of depressive symptoms post treatment measure: Motivation for change post treatment measure: Level of identification with the eating disorder and level of embodiment post treatment measure: Experience of the eating disorder voice post treatment measure: Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale measure: Total score of eating disorder voice characteristics post treatment measure: Level of quality of life post treatment measure: Perceived difference in power between eating disorder voice and eating disorder patient post treatment measure: Level of acceptance of and action in relation to the eating disorder voice post treatment measure: Level of self-compassion post treatment measure: Level of body dissatisfaction post treatment measure: Level of perceived self-efficacy post treatment measure: Ability to regulate emotion post treatment measure: Level of executive functioning post treatment measure: Participant satisfaction measure: Presence of childhood traumas measure: Level of simulator sickness measure: Level of dysfunctional cognitive beliefs post treatment measure: Positive and negative aspects of eating disorders as perceived by the participant post treatment measure: Personal recovery post treatment measure: Presence of comorbidity measure: Cost effectiveness of the intervention measure: Level of cognitive (in)flexibility post treatment measure: Monitoring and reporting of adverse and unwanted events measure: Level of immersion in virtual reality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen Research Center for Mental Health - CORE status: RECRUITING city: Hellerup state: Copenhagen zip: 2900 country: Denmark name: Nina K Hansen, MSc (Psych.) role: CONTACT phone: 21699487 phoneExt: +45 email: nina.kappel.hansen@regionh.dk name: Louise B Glenthøj, DMSc, PhD role: CONTACT phone: 21452889 phoneExt: +45 email: louise.birkedal.glenthoej@regionh.dk name: Louise B Glenthøj, DMSc, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.73204 lon: 12.57093 hasResults: False