RecruitingNot ApplicableNCT06345040

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


Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Enrollment

96 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • ≥ Age 18 of years
  • Ability to give informed consent
  • A diagnosis of eating disorder (ICD-10 code: F50.0 - F.50.3)
  • Recognizing having an internal eating disorder voice

Exclusion Criteria7

  • Unable to identify an internal eating disorder voice
  • Organic brain disease
  • Comorbid psychosis
  • Psychotic depression
  • Active suicidal ideations
  • Risk of refeeding syndrome
  • A command of spoken Danish or English inadequate for engaging in therapy

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Interventions

BEHAVIORALVirtual-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.

BEHAVIORALTAU - 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

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NCT06345040


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