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

项目摘要/摘要 神经性厌食症(AN)是一种代价高昂且危及生命的疾病。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，急性情况下的出院标准为 典型的体重恢复。然而，研究表明，基于体重的恢复是不够的，而且 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)对这类人群很有用，包括出院后，可能有助于解决心理问题 症状，实现完全康复，减少复发。然而，很少有患者能够接触到 供应商接受了这些技术的培训。移动健康技术具有指数级增长的巨大潜力 通过解决治疗障碍，为AN的急性后治疗提供高质量的服务，但 迄今为止，对这些方法的研究极为有限。我们的团队成功地开发了一种 基于CBT的指导式自助移动应用程序，学生身体进食障碍(SB-ED)，已经演示 患有狂欢/净化类型ED的大学女生的有效性。与此同时，我们已经展示了 为成人ANN的急性后护理和复发预防提供面对面的CBT支持。的首要目标是 这款R34是开发和测试基于CBT的、经过培训的移动应用程序，以解决急性后护理和复发 预防AN，基于：1)我们自己的应用程序，用于治疗暴饮型/清除型ED；2)我们在- 个人将CBT用于AN的急性后护理；以及3)对具有高度理论性的附加特征的研究 在急性后时期支持患有AN的个人的潜力-这是一种社交网络功能，可提供 与有共同经历的个人进行积极互动的机会。建议的目标1 在相关利益攸关方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 并增加了社交网络功能。然后，我们将通过三个方面进一步细化干预 总计N=20的几轮可用性测试。在目标2中，我们将进行一项试点随机对照试验(N=90) 移动干预与移动干预+社交网络与常规治疗的对比 (Tau)。我们将评估移动干预相对于移动干预的初步可行性和有效性 移动干预加社交网络与TAU在减少ED精神病理方面的比较(主要 结果)，减少勃起功能障碍行为，实现体重保持，减少抑郁和自杀念头， 减少临床损害。我们还将研究移动干预是否会改变拟议的 目标以及目标的变化是否与临床益处相关，以及进行探索性研究 分析以确定应用程序内部的结果预测者和调节者。影响的规模和自然减员的估计将有助于 在R01随机对照试验的规划中，我们将在更大范围内测试这款应用程序，为我们带来 更接近于实现我们的目标，即为患有AND的患者增加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.