protocolSection identificationModule nctId: NCT06345040, orgStudyIdInfo id: H-22067692, briefTitle: The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mental Health Services in the Capital Region, Denmark, class: OTHER, descriptionModule 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., conditionsModule conditions: Eating Disorders, conditions: Anorexia Nervosa, conditions: Bulimia Nervosa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Virtual-reality intervention, interventions name: TAU - specialized treatment, outcomesModule primaryOutcomes measure: Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire, secondaryOutcomes measure: Level of depressive symptoms post treatment, secondaryOutcomes measure: Motivation for change post treatment, secondaryOutcomes measure: Level of identification with the eating disorder and level of embodiment post treatment, secondaryOutcomes measure: Experience of the eating disorder voice post treatment, secondaryOutcomes measure: Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale, otherOutcomes measure: Total score of eating disorder voice characteristics post treatment, otherOutcomes measure: Level of quality of life post treatment, otherOutcomes measure: Perceived difference in power between eating disorder voice and eating disorder patient post treatment, otherOutcomes measure: Level of acceptance of and action in relation to the eating disorder voice post treatment, otherOutcomes measure: Level of self-compassion post treatment, otherOutcomes measure: Level of body dissatisfaction post treatment, otherOutcomes measure: Level of perceived self-efficacy post treatment, otherOutcomes measure: Ability to regulate emotion post treatment, otherOutcomes measure: Level of executive functioning post treatment, otherOutcomes measure: Participant satisfaction, otherOutcomes measure: Presence of childhood traumas, otherOutcomes measure: Level of simulator sickness, otherOutcomes measure: Level of dysfunctional cognitive beliefs post treatment, otherOutcomes measure: Positive and negative aspects of eating disorders as perceived by the participant post treatment, otherOutcomes measure: Personal recovery post treatment, otherOutcomes measure: Presence of comorbidity, otherOutcomes measure: Cost effectiveness of the intervention, otherOutcomes measure: Level of cognitive (in)flexibility post treatment, otherOutcomes measure: Monitoring and reporting of adverse and unwanted events, otherOutcomes measure: Level of immersion in virtual reality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen Research Center for Mental Health - CORE, status: RECRUITING, city: Hellerup, state: Copenhagen, zip: 2900, country: Denmark, contacts name: Nina K Hansen, MSc (Psych.), role: CONTACT, phone: 21699487, phoneExt: +45, email: nina.kappel.hansen@regionh.dk, contacts name: Louise B Glenthøj, DMSc, PhD, role: CONTACT, phone: 21452889, phoneExt: +45, email: louise.birkedal.glenthoej@regionh.dk, contacts name: Louise B Glenthøj, DMSc, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False