NCT06345040

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

March 14, 2024

Last Update Submit

April 2, 2024

Conditions

Eating DisordersAnorexia NervosaBulimia Nervosa

Keywords

Virtual reality-assisted therapyEating DisordersAnorexia NervosaBulimia Nervosaeating disorder voiceanorexic voiceavatar therapyexternalizationrelational therapy

Outcome Measures

Primary Outcomes (1)

  • Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire

    The primary outcome of the study is eating disorder symptoms measured with the Eating Disorder Examination Questionnaire (EDE-Q) post treatment (12 weeks follow up). The EDE-Q is a widely used and validated self-report questionnaire to assess eating disorder psychopathology and behaviors . It comprises 22 items, rated according to a seven-point forced-choice format (0-6). The questionnaire provides information about eating disorders' central behavioral features (e.g., binge eating, vomiting, laxative misuse), with higher scores reflecting greater symptom severity or frequency. There are four subscales: restraint, eating, shape, and weight concern. Cronbach's α = 0.860.

    Baseline, at 12 weeks, and at 24 weeks follow up.

Secondary Outcomes (5)

  • Level of depressive symptoms post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • Motivation for change post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • Level of identification with the eating disorder and level of embodiment post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • Experience of the eating disorder voice post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale

    Baseline, at 12 weeks, and at 24 weeks follow up.

Other Outcomes (20)

  • Total score of eating disorder voice characteristics post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • Level of quality of life post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • Perceived difference in power between eating disorder voice and eating disorder patient post treatment

    Baseline, at 12 weeks, and at 24 weeks follow up.

  • +17 more other outcomes

Study Arms (2)

Virtual-reality assisted therapy + treatment as usual

EXPERIMENTAL

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.

Virtual-reality assisted therapy + treatment as usual
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.

Treatment as usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Research Center for Mental Health - CORE

Hellerup, Copenhagen, 2900, Denmark

RECRUITING

Related Publications (1)

  • Hansen NK, Ries ES, Ward T, Cardi V, Christensen AB, Hjorthoj C, Nordentoft M, Micali N, Glenthoj LB. The Dialogue study: Protocol for a randomized clinical trial evaluating the efficacy of virtual reality-based psychotherapy plus treatment as usual versus treatment as usual for eating disorders. PLoS One. 2025 Jul 28;20(7):e0319875. doi: 10.1371/journal.pone.0319875. eCollection 2025.

    PMID: 40720536DERIVED

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Nina K Hansen, MSc (Psych.)

CONTACT

21699487nina.kappel.hansen@regionh.dk

Louise B Glenthøj, DMSc, PhD

CONTACT

21452889nina.kappel.hansen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2024

First Posted

April 3, 2024

Study Start

February 26, 2024

Primary Completion

December 1, 2025

Study Completion

June 1, 2026

Last Updated

April 3, 2024

Record last verified: 2024-03

Locations

DK(1)