Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06345040

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

Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2024-04-03

96

Participants Needed

1

Research Sites

118 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to give informed consent
  • Diagnosed with an eating disorder (ICD-10 codes F50.0 to F50.3)
  • Recognizes having an internal eating disorder voice
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Copenhagen Research Center for Mental Health - CORE

Hellerup, Copenhagen, Denmark, 2900

Actively Recruiting

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Research Team

N

Nina K Hansen, MSc (Psych.)

CONTACT

L

Louise B Glenthøj, DMSc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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