Clinical trial NCT06345040: The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders
Official title: The Dialogue Study: A Randomized Clinical Trial Investigating the Effect of a Virtual-reality Based Treatment for Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
relational therapy
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
Secondary outcomes:
measure: Level of depressive symptoms post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Motivation for change post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of identification with the eating disorder and level of embodiment post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Experience of the eating disorder voice post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
Other outcomes:
measure: Total score of eating disorder voice characteristics post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of quality of life post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Perceived difference in power between eating disorder voice and eating disorder patient post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of acceptance of and action in relation to the eating disorder voice post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of self-compassion post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of body dissatisfaction post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of perceived self-efficacy post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Ability to regulate emotion post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of executive functioning post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Participant satisfaction
timeFrame: 12 weeks follow up.
measure: Presence of childhood traumas
timeFrame: Baseline.
measure: Level of simulator sickness
timeFrame: 2 weeks and 7 weeks post baseline.
measure: Level of dysfunctional cognitive beliefs post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Positive and negative aspects of eating disorders as perceived by the participant post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Personal recovery post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Presence of comorbidity
timeFrame: Baseline.
measure: Cost effectiveness of the intervention
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Level of cognitive (in)flexibility post treatment
timeFrame: Baseline, at 12 weeks, and at 24 weeks follow up.
measure: Monitoring and reporting of adverse and unwanted events
timeFrame: 12 weeks follow up.
measure: Level of immersion in virtual reality
timeFrame: 2 weeks and 7 weeks post baseline.
Locations:
city: Hellerup
country: Denmark
facility: Copenhagen Research Center for Mental Health - CORE
state: Copenhagen
Study officials:
References: