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

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Bulimia Nervosa; Eating Disorders; Anorexia Nervosa

Treatments: Behavioral: TAU - specialized treatment; Behavioral: Virtual-reality intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06345040

H-22067692

Details and patient eligibility

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Virtual-reality assisted therapy + treatment as usual

Experimental group

Description:

Seven sessions

Treatment:

Behavioral: Virtual-reality intervention

Treatment as usual (TAU)

Active Comparator group

Description:

Seven sessions

Treatment:

Behavioral: TAU - specialized treatment