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

NCT ID: NCT06345040

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual-reality assisted therapy + treatment as usual

Seven sessions

Group Type: EXPERIMENTAL

Virtual-reality intervention

Intervention Type: BEHAVIORAL

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.

Treatment as usual (TAU)

Seven sessions

Group Type: ACTIVE_COMPARATOR

TAU - specialized treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Copenhagen Research Center for Mental Health - CORE

Hellerup, Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nina K Hansen, MSc (Psych.)

Role: CONTACT

nina.kappel.hansen@regionh.dk

21699487 ext. +45

Louise B Glenthøj, DMSc, PhD

Role: CONTACT

nina.kappel.hansen@regionh.dk

21452889 ext. +45

Facility Contacts

Nina K Hansen, MSc (Psych.)

Role: primary

nina.kappel.hansen@regionh.dk

21699487 ext. +45

Louise B Glenthøj, DMSc, PhD

Role: backup

louise.birkedal.glenthoej@regionh.dk

21452889 ext. +45

References

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.

Reference Type: DERIVED

PMID: 40720536 (View on PubMed)

Other Identifiers

H-22067692

Identifier Type: -

Identifier Source: org_study_id