CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled / 96 target
Drug / intervention
Virtual-reality intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06345040
NCT06345040N/ACompletedOn Track (3.4/mo)Completion was 9mo ago

The Dialogue Study: A Randomized Clinical Trial Investigating the Effect of a Virtual-reality Based Treatment for Eating Disorders

University Hospital Bispebjerg and Frederiksberg·interventional·Posted Apr 3, 2024·Updated Jun 25, 2026

In Brief

A clinical study evaluating Virtual-reality intervention and TAU - specialized treatment for Eating Disorders and 2 related conditions. Completed, enrolled 96 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedApr 3, 2024
Enrollment StartFeb 26, 2024
Primary CompletionSep 22, 2025
Study CompletionDec 20, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 2.2 years ago

Arms & Interventions

Virtual-reality assisted therapy + treatment as usualexperimental

Seven sessions

Behavioral: Virtual-reality intervention
Treatment as usual (TAU)active_comparator

Seven sessions

Behavioral: TAU - specialized treatment

Interventions

Virtual-reality interventionbehavioral

For the experimental condition, participants will receive seven individual sessions of Virtual Reality Therapy conducted by a therapist trained in both eating disorder psychotherapy and virtual reality-based therapy, including avatar therapy. In the initial stage of therapy participants create a virtual avatar embodying their eating disorder voice. This enables the person to engage in real time face to face dialogue with the eating disorder voice. The main goal of the intervention is to encourage participants to stand up to the negative comments and commands made by the eating disorder voice and hereby increase their power and agency in the context of the eating disorder voice.

TAU - specialized treatmentbehavioral

The control condition encompasses treatment as usual comprising seven sessions of specialized treatment, such as individual or group psychotherapy and dietary guidance, provided by interdisciplinary health professionals.