Development and Pilot Testing of a Cognitive-Behavioral Therapy-Guided Self-Help Mobile App for the Post-Acute Treatment of Anorexia Nervosa

项目概要/摘要 神经性厌食症（AN）是一种昂贵且危及生命的疾病。患有严重AN的患者通常在 急性发作，但治疗后复发是常见的。此外，急性环境中的出院标准是 通常是体重恢复。然而，研究表明，基于体重的恢复是不够的， 完全康复包括身体行为和心理方面的因素认知行为疗法 (CBT)对这一人群有用，包括出院后，并可能有助于解决心理问题。 症状，实现完全恢复，并减少复发。然而，很少有患者能够获得 提供者在这些技术培训。移动医疗技术有很大的潜力， 通过解决治疗障碍，获得高质量的AN急性期后治疗服务，但 迄今为止，对这些方法的研究极为有限。我们的团队已经成功地开发了一种 引导自助基于CBT的移动的应用程序，学生身体饮食失调（SB-ED），它已经证明 在大学女性狂欢/净化型ED中的有效性。与此同时，我们已经证明， 为成人AN的急性期后护理和复发预防提供现场CBT支持。的首要目标 这个R34是开发和测试一个基于CBT的、有指导的移动的应用程序，以解决急性期后护理和复发问题 预防AN，基于：1）我们自己的治疗狂欢/净化型ED的应用程序; 2）我们在 个人使用CBT进行AN的急性期后护理;以及3）研究具有高理论价值的附加功能 支持急性期后AN患者的潜力-一种社交网络功能， 与有共同经历的个人进行积极互动的机会。在拟议的目标1中， 在相关利益相关者咨询委员会的指导下，我们将为此调整现有的SB-ED应用程序 人口和添加社交网络功能。然后，我们将通过三个方面进一步细化干预措施 总共N=20轮可用性测试。在目标2中，我们将进行一项初步随机对照试验（N=90） 移动的干预与移动的干预加社交网络与常规治疗的对比 （TAU）。我们将评估移动的干预与 移动的干预加社交网络与TAU在减少艾德精神病理学（主要 结果），减少艾德行为，实现体重维持，减少抑郁和自杀意念， 并减少临床损伤。我们还将研究移动的干预是否改变了拟议的 目标以及目标变化是否与临床获益相关，以及进行探索性研究 分析以确定应用程序内预测因素和结果调节因素。效应量和损耗估计将有助于 在R 01随机对照试验的规划中，我们将在更大范围内测试该应用程序， 更接近于实现我们的目标，即增加AN患者获得循证治疗的机会， 最终防止这种致命疾病可能导致的极端负面后果。

PROJECT SUMMARY/ABSTRACT Anorexia nervosa (AN) is a costly and life-threatening illness. Patients with severe AN are often treated in the acute setting, but relapse after treatment is common. Further, the discharge criterion in acute settings is typically weight restoration. However, research has indicated that weight-based recovery is not “enough” and that full recovery involves physical, behavioral, and psychological components. Cognitive-behavioral therapy (CBT) is useful with this population, including following discharge, and may aid in addressing psychological symptoms, achieving full recovery, and decreasing relapse. However, very few patients have access to providers trained in these techniques. mHealth technologies have great potential to exponentially increase access to high-quality services for the post-acute treatment of AN by addressing barriers to treatment, but to date, research on these approaches has been extremely limited. Our team has successfully developed a guided self-help CBT-based mobile app, StudentBodies-Eating Disorders (SB-ED), which has demonstrated effectiveness among college women with binge/purge-type EDs. At the same time, we have demonstrated support for in-person CBT for the post-acute care and relapse prevention of adult AN. The overarching goal of this R34 is to develop and test a CBT-based, coached mobile app to address the post-acute care and relapse prevention of AN, based on: 1) our own app for the treatment of binge/purge-type EDs; 2) our work on in- person use of CBT for post-acute care of AN; and 3) research on an additional feature that has high theoretical potential for supporting individuals with AN in the post-acute period—a social networking feature that provides the opportunity for positive interactions with individuals with shared experiences. In Aim 1 of the proposed work, guided by an Advisory Board of relevant stakeholders, we will adapt the existing SB-ED app for this population and add a social networking feature. Then, we will further refine the intervention through three rounds of usability testing with N=20 total. In Aim 2, we will conduct a pilot randomized controlled trial (N=90) of the mobile intervention versus the mobile intervention plus social networking versus treatment as usual (TAU). We will estimate the preliminary feasibility and effectiveness of the mobile intervention versus the mobile intervention plus social networking versus TAU in terms of reducing ED psychopathology (primary outcome), reducing ED behaviors, achieving weight maintenance, reducing depression and suicidal ideation, and reducing clinical impairment. We will also examine whether the mobile intervention changes the proposed targets and whether changes in targets are associated with clinical benefit, as well as conduct exploratory analyses to identify within-app predictors and moderators of outcome. Effect size and attrition estimates will aid in the planning of an R01 randomized controlled trial where we will test the app on a larger scale, bringing us closer to achieving our goal of increasing access to evidence-based treatment for individuals with AN and ultimately preventing the extreme negative consequences that can result from this deadly disorder.