FlexED: A Digital, Gamified Early Intervention for Eating Disorders

饮食失调(EDs)是一种严重的精神疾病，对年轻女性的影响不成比例1，2。 干预，当个体表现出一些体征和症状时，但在行为变得更多之前 自动和根深蒂固的可以减少显著的发病率和死亡率3-6。然而，有有限的 早期勃起功能障碍干预和勃起功能障碍治疗普遍受到机会和参与的限制7-10。数位 干预措施有很高的潜力克服获得障碍并最大限度地吸引年轻人 对于ED onset2、11的风险，尚未开发。许多数字干预只是将信息或面对面 将活动转变为在线形式或侧重于筛查和转诊，干预措施主要基于 传统认知行为疗法(CBT)10、12。很少有人(如果有的话)采用以用户为中心的设计方法 开发或使用游戏化，这可能会通过操作者增加参与度和学习 学习原则。在最初的概念验证研究中，我们试用了一种新的数字化、游戏化的干预方法 关于接受和承诺疗法(ACT)13.不是典型的体重测量方法 出于对ED的担忧，干预使用游戏化来体验性地训练身体形象的灵活性 (BIF)(即，对身体有痛苦的想法/感觉的能力，而不需要不必要的尝试 避免或逃避这些经历，追求其他对个人有意义的价值观或目标)。这是一种新的 在初步支持下的方向，并将是早期ED干预的范式转变，其重点是 关于改变或消除身体形象困扰。这一分阶段的R61/R33(NIH阶段1A-B)需要用户- 以中心设计和实验治疗学方法进一步发展和优化干预 适用于美国有勃起功能障碍症状的年轻女性。在R61阶段的研究中，使用 精简的内容、增强的图形和交互功能，我们进行迭代用户测试以 最大限度地提高BIF的可接受性和影响力(目标1)。然后，我们使用多基线实验 参与者测试干预措施对BIF(我们的目标改变机制)的影响，以及 确定治疗剂量(目标2)。在R33阶段，我们进行了试点RCT比较Flexed到 在线教育控制。我们测试了干预对BIF的影响和相关的临床益处，并 作为另一项测试，评估干预是否导致身体形象困扰和行为脱钩 我们的变革机制(目标1)。我们还测试了一个虚拟身体-行为方法任务作为评估 在对个人有意义或有价值的背景下对生物多样性框架进行评估，以便在今后的调查中使用(目标2)。最后， 我们评估最终屈曲干预的可接受性，如保留(目标3)所示。这项建议 准备进行更大规模的试验，并进行更长期的跟踪，最终目的是建立一种成本效益高、 广泛可用的早期干预措施，以减少EDS的社会影响1。

Eating disorders (EDs) are serious psychiatric illnesses that disproportionately affect young women1, 2. Early intervention, when individuals show some signs and symptoms, but before behaviors become more automatic and entrenched can mitigate significant morbidity and mortality3-6. However, there are limited early ED interventions and ED treatment broadly suffers limited access and engagement7-10. Digital interventions have high potential to overcome access barriers and appeal to young people at greatest risk for ED onset2, 11, yet are undeveloped. Many digital interventions simply convert information or in-person activities to an online format or focus on screening and referral, and interventions are primarily based in traditional cognitive-behavioral therapy (CBT)10, 12. Few (if any) have taken a user-centered design approach to development or used gamification, which may increase engagement and learning through operant learning principles. In an initial proof of concept study, we piloted a novel digital, gamified intervention based on Acceptance and Commitment Therapy (ACT)13. Rather than the typical approach to the body weight concerns that underlie EDs, the intervention used gamification to experientially train body-image flexibility (BIF) (i.e., the ability to have distressing thoughts/feelings about the body, without unnecessary attempts to avoid or escape these experiences, and pursue other personally meaningful values or goals). This is a new direction with preliminary support, and would be a paradigm shift in early ED intervention, which has focused on changing or eliminating body-image distress. This Phased R61/R33 (NIH Stage 1A-B) takes a user- centered design and experimental therapeutics approach to further develop and optimize the intervention for young women in the US with ED symptoms. In the R61 Phase of the study, draft sessions are built with streamlined content, and enhanced graphics and interactive features, and we conduct iterative user testing to maximize acceptability and impact on BIF (Aim 1). We then use a multiple baseline experiment across participants to test the effect of the intervention (“FlexED”) on BIF, our targeted mechanism of change, and establish treatment dose (Aim 2). During the R33 Phase, we conduct a pilot RCT comparing FlexED to an online educational control. We test the effect of the intervention on BIF and the associated clinical benefit, and assess whether the intervention results in decoupling of body-image distress and behavior as an additional test of our mechanism of change (Aim 1). We also test a virtual body-Behavioral Approach task as an assessment of BIF in a personally meaningful or valued context that may be used in future investigations (Aim 2). Finally, we assess the acceptability of the final FlexED intervention, as indicated by retention (Aim 3). This proposal prepares for a larger trial with longer-term follow up, with the ultimate aim of establishing a cost-effective, widely available early intervention to decrease the societal impact of EDs1.