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RECRUITINGINTERVENTIONAL

The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. ≥ Age 18 of years 2. Ability to give willing to sign a consent form 3. A diagnosis of eating disorder (ICD-10 code: F50.0 - F.50.3) 4. Recognizing having an internal eating disorder voice Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Virtual-reality intervention

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.

BEHAVIORAL

TAU - specialized treatment

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.

Locations (1)

Copenhagen Research Center for Mental Health - CORE
Hellerup, Copenhagen, Denmark