Eating DisordersNCT06345040
The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders
A study testing Virtual-reality intervention and TAU - specialized treatment in people with Eating Disorders and Anorexia Nervosa, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Virtual-reality intervention and TAU - specialized treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Feb 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Research Center for Mental Health - CORE
Hellerup, Copenhagen, 2900
About this study
Official title: The Dialogue Study: A Randomized Clinical Trial Investigating the Effect of 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 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.
Read the detailed description
Eating disorders can be defined as pathological eating habits and a tendency to overestimate weight and body shape. It affects at least 7 % of the global population and has profound physical and psychological costs for the affected individual comprising a high risk of relapse and death. Additionally, eating disorders are associated with a significant economic burden in terms of health care costs and lower employment rates.
There is considerable interest in the development of novel psychological interventions for eating disorders which are more effective and which target characteristics that could potentially serve as maintaining factors in eating disorder pathology. The majority (94%) of patients with an eating disorder report experiencing a dominant critical internal voice commenting on weight and self-worth, often referred to as the eating disorder voice.
Within psychotic disorders, a virtual reality-based therapy termed avatar therapy has proven highly effective in reducing the power of the psychotic voice and consequently alleviating the associated distress. Building on this evidence we have developed a modified version of the avatar treatment protocol targeting patients with an eating disorder.
The objective of the Dialogue Study is to identify whether this virtual reality-based therapy can reduce symptoms, improve quality of life, and be cost-effective in treating patients with an eating disorder. Two feasibility studies have found the intervention to be feasible and acceptable for individuals with an eating disorder. Evidence on the efficacy of the intervention now needs to be tested in a large methodological rigorous trial. If the results of the randomized clinical trial are positive, it may motivate scalability and potential implementation in the clinics treating adults with an eating disorder.
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- Being tested
- Virtual-reality intervention, TAU - specialized treatment
- Keywords
- Virtual reality-assisted therapy, Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, eating disorder voice, anorexic voice, avatar therapy, externalization, relational therapy
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual-reality interventionBehavioural
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.
TAU - specialized treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual-reality assisted therapy + treatment as usual | Experimental | Seven sessions Receives: Behavioral: Virtual-reality intervention |
| Treatment as usual (TAU) | Active comparator | Seven sessions Receives: Behavioral: TAU - specialized treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, at 12 weeks, and at 24 weeks follow up.
Secondary outcomes (5)
Level of depressive symptoms post treatment
Level of depressive symptoms post treatment measured with The Hospital Anxiety and Depression Scale (HADS), subscale Depression. HADS is a self-reporting questionnaire consisting of 14 items measuring the level of anxiety and depression. Items for anxiety and depression are scored separately on a scale from 0-3 with a score range of 0-21 for both subscales. The higher the score the higher symptom load.
Measured: Baseline, at 12 weeks, and at 24 weeks follow up.
Motivation for change post treatment
Motivation for change as experienced by the participant post treatment measured with the Stages of Change in Eating Disorders Questionnaire (SOCQ-ED) The SOCQ-ED comprises 13 items measuring motivation to change. For each item, the participant selects among seven different response options which reflects the possible stage of change (i.e. precontemplation, contemplation, preparation, action, maintenance, and termination). Items are rated on a 6-point Likert scale ranging from 1-7, one being the possibility to exclude an irrelevant symptom domain. The higher score the more motivation to change.
Measured: Baseline, at 12 weeks, and at 24 weeks follow up.
Level of identification with the eating disorder and level of embodiment post treatment
Level of identification with the eating disorder and level of embodiment post treatment measured with the Identity and Eating Disorder Questionnaire (IDEA). IDEA is a 23 item self-report questionnaire assessing identification with the eating order and the experience of being (dis)embodied. Items are rated on a 5-point Likert scale ranging from 0 (do not agree) to 4 (strongly agree). The total score is the average of all item ratings. The higher score the more identification with the eating disorder and the less experienced embodiment.
Measured: Baseline, at 12 weeks, and at 24 weeks follow up.
Experience of the eating disorder voice post treatment
The experience of the eating disorder voice post treatment assessed with the Experience of An Anorexic Voice Questionnaire (EAVE-Q). The EAVE-Q is a self-report questionnaire containing 18 items covering the experience of the eating disorder voice. Each question is scored from 1 (strongly disagree) to 5 (strongly agree). Higher EAVE-Q score is associated with higher symptom load in terms of eating disorder symptoms, depression- and anxiety symptoms, and decreased quality of life.
Measured: 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
Level of engagement with the eating disorder voice post treatment measured with the Revised Beliefs About Voices questionnaire (BAVQR), subscale Engagement. BAVQR is a self-report questionnaire with 5 subscales assessing the individual's beliefs about the power and the benevolence/malevolence of the voice and the emotional, and behavioral ways of responding to it. Participants indicate responses on a 4-point Likert scale ranging from disagree (0) to strongly agree (3). The Engagement subscale is divided into emotional and behavioral ways of reacting. The higher score the more emotional and behavioral engagement.
Measured: Baseline, at 12 weeks, and at 24 weeks follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start26 Feb 2024
- Primary completion22 Sep 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Birkedal Glenthoej, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345040
- Sponsor's protocol ID
- H-22067692
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40720536
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dialogue Study: A Randomized Clinical Trial Investigating the Effect of a Virtual-reality Based Treatment for Eating Disorders
- ClinicalTrials.gov ID
- NCT06345040
- Acronym / sponsor ID
- H-22067692
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- Keywords
- Virtual reality-assisted therapy, Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, eating disorder voice, anorexic voice, avatar therapy, externalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eating disorders can be defined as pathological eating habits and a tendency to overestimate weight and body shape. It affects at least 7 % of the global population and has profound physical and psychological costs for the affected individual comprising a high risk of relapse and death. Additionally, eating disorders are associated with a significant economic burden in terms of health care costs and lower employment rates.
There is considerable interest in the development of novel psychological interventions for eating disorders which are more effective and which target characteristics that could potentially serve as maintaining factors in eating disorder pathology. The majority (94%) of patients with an eating disorder report experiencing a dominant critical internal voice commenting on weight and self-worth, often referred to as the eating disorder voice.
Within psychotic disorders, a virtual reality-based therapy termed avatar therapy has proven highly effective in reducing the power of the psychotic voice and consequently alleviating the associated distress. Building on this evidence we have developed a modified version of the avatar treatment protocol targeting patients with an eating disorder.
The objective of the Dialogue Study is to identify whether this virtual reality-based therapy can reduce symptoms, improve quality of life, and be cost-effective in treating patients with an eating disorder. Two feasibility studies have found the intervention to be feasible and acceptable for individuals with an eating disorder. Evidence on the efficacy of the intervention now needs to be tested in a large methodological rigorous trial. If the results of the randomized clinical trial are positive, it may motivate scalability and potential implementation in the clinics treating adults with an eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual-reality assisted therapy + treatment as usual | Experimental | Behavioral: Virtual-reality interventionSeven sessions |
| Treatment as usual (TAU) | Active comparator | Behavioral: TAU - specialized treatmentSeven sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (7 listed)
- Unable to identify an internal eating disorder voice
- Organic brain disease
- Comorbid psychosis
- Psychotic depression
- Active suicidal ideations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual-reality interventionFor 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. | Behavioural | Virtual-reality assisted therapy + treatment as usual |
| TAU - specialized treatmentThe 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. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire
Time frame: Baseline, at 12 weeks, and at 24 weeks follow up.
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.
5 secondary outcomes
Level of depressive symptoms post treatment
Time frame: Baseline, at 12 weeks, and at 24 weeks follow up.
Motivation for change post treatment
Time frame: Baseline, at 12 weeks, and at 24 weeks follow up.
Level of identification with the eating disorder and level of embodiment post treatment
Time frame: Baseline, at 12 weeks, and at 24 weeks follow up.
Experience of the eating disorder voice post treatment
Time frame: 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
Time frame: Baseline, at 12 weeks, and at 24 weeks follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 40720536Hansen 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.
Related trials for Eating Disorders
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual-reality intervention and TAU - specialized treatment in people with Eating Disorders and Anorexia Nervosa, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire (time frame: Baseline, at 12 weeks, and at 24 weeks follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.