FlexED: A Digital, Gamified Early Intervention for Eating Disorders

FlexED：针对饮食失调的数字化、游戏化早期干预

• 批准号: 10704612
• 负责人: Rhonda M Merwin
• 金额: $ 42.3万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10704612
• 关键词: Adolescent and Young Adult; Affect; Behavior; Behavior Disorders; Behavioral; Body Image; Body Weight; Body measure procedure; Cessation of life; Clinical; Cognitive Therapy; Cyprus; Deterioration; Development; Distress; Dose; E-learning; Early Intervention; Eating Disorders; Ecological momentary assessment; Education; Elements; Environment; Exercise; Feeling; Friends; Future; Goals; Health Services Accessibility; Image; Impairment; Individual; Intervention; Interview; Investigation; Investigational Therapies; Learning; Life; Measures; Mental disorders; Morbidity - disease rate; Onset of illness; Outcome; Participant; Patient Self-Report; Pattern; Persons; Phase; Physiological; Process; Prognosis; Questionnaires; Randomized; Risk; Signal Transduction; Signs and Symptoms; Symptoms; Testing; Therapeutic; Therapeutic Intervention; Thinking; Training; United States National Institutes of Health; acceptability and feasibility; aged; cohort; cost effective; digital; digital intervention; effective intervention; experience; experimental study; flexibility; follow-up; functional outcomes; girls; high risk; improved; improved outcome; indexing; innovation; intervention effect; meetings; mortality; multimodality; novel; post intervention; premature; programs; psychologic; recruit; screening; treatment effect; user centered design; virtual; willingness; young woman

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.

进食障碍（ED）是严重的精神疾病，不成比例地影响年轻女性1，2。早期 干预，当个人表现出一些迹象和症状，但在行为变得更 自动和固定的方法可以显著降低发病率和死亡率3 -6。然而， 早期艾德干预和艾德治疗广泛地受到有限的获取和实施7 -10。数字 干预措施很有可能克服获得服务的障碍，最大限度地吸引年轻人 艾德发作的风险2，11，尚未开发。许多数字干预措施只是将信息或亲自 活动改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（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，这可能会增加参与和学习，通过操作 学习原则。在最初的概念验证研究中，我们试行了一种基于数字化、游戏化干预的新方法， 接受和承诺疗法（ACT）而不是典型的体重方法 关注ED的基础，干预使用游戏化来经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，没有不必要的尝试， 避免或逃避这些经历，追求其他对个人有意义的价值或目标）。这是一个新 这将是早期艾德干预的范式转变， 改变或消除身体形象困扰的方法。R61/R33阶段（NIH Stage 1A-B）需要用户- 中心设计和实验治疗方法，以进一步开发和优化干预措施 有艾德症状的年轻女性。在研究的R61阶段， 精简的内容，增强的图形和交互功能，我们进行迭代的用户测试， 最大化可接受性和对BIF的影响（目标1）。然后，我们使用多个基线实验， 参与者测试干预（“FlexED”）对BIF的影响，我们的目标变化机制，以及 确定治疗剂量（目标2）。在R33阶段，我们进行了一项试点RCT，将FlexED与 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， 评估干预是否导致身体形象困扰和行为脱钩，作为额外的测试 我们的变革机制（目标1）。我们还测试了虚拟身体行为方法任务作为评估 在个人有意义或有价值的背景下使用BIF，可用于未来的调查（目标2）。最后， 我们评估最终FlexED干预的可接受性，如保留所示（目标3）。这项建议 准备进行更大规模的试验，并进行长期随访，最终目标是建立一个具有成本效益的， 广泛提供早期干预，以减少ED的社会影响1。