The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders
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 diagno
| Condition(s) | Eating Disorders, Anorexia Nervosa, Bulimia Nervosa |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. ≥ Age 18 of years 2. Ability to give informed consent 3. A diagnosis of eating disorder (ICD-10 code: F50.0 - F.50.3) 4. Recognizing having an internal eating disorder voice Exclusion Criteria: 1. Unable to identify an internal eating disorder voice 2. Organic brain disease 3. Comorbid psychosis 4. Psychotic depression 5. Active suicidal ideations 6. Risk of refeeding syndrome 7. A command of spoken Danish or English inadequate for engaging in therapy |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
| Locations | Hellerup, Copenhagen, Denmark |
| Start date | 2024-02-26 |
| NCT ID | NCT06345040 |
| Official listing | https://clinicaltrials.gov/study/NCT06345040 |