The Dialogue Study: A Randomized Clinical Trial Investigating the Effect of a Virtual-reality Based Treatment for Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Virtual-reality assisted therapy + treatment as usual
Seven sessions
干预措施: Virtual-reality intervention (Behavioral)
Treatment as usual (TAU)
Seven sessions
干预措施: TAU - specialized treatment (Behavioral)
结局指标
主要结局
Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire
时间窗: 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.
次要结局
- Experience of the eating disorder voice post treatment(Baseline, at 12 weeks, and at 24 weeks follow up.)
- Level of depressive symptoms post treatment(Baseline, at 12 weeks, and at 24 weeks follow up.)
- Motivation for change 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(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(Baseline, at 12 weeks, and at 24 weeks follow up.)
研究者
Louise Birkedal Glenthoej
Associate professor, Department of Psychology, University of Copenhagen Head of VIRTU Research Group, DMSc, PhD
University Hospital Bispebjerg and Frederiksberg