Anorexia Nervosa, Bulimia Nervosa, Eating Disorders
Conditions
Keywords
Virtual reality-assisted therapy, Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, eating disorder voice, anorexic voice, avatar therapy, externalization, relational therapy
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.
Interventions
BEHAVIORALVirtual-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.
BEHAVIORALTAU - 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.
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of depressive symptoms post treatment | Baseline, at 12 weeks, and at 24 weeks follow up. | 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. |
| Motivation for change post treatment | Baseline, at 12 weeks, and at 24 weeks follow up. | 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. |
| Level of identification with the eating disorder and level of embodiment 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 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. |
| Experience of the eating disorder voice post treatment | Baseline, at 12 weeks, and at 24 weeks follow up. | 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. |
| 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. | 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. |
Countries
Denmark
Outcome results
None listed