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

用于神经性厌食症急性后治疗的认知行为治疗引导自助移动应用程序的开发和试点测试

基本信息

批准号：
10653997
负责人：
Ellen E. Fitzsimmons-Craft
金额：
$ 27.31万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-01 至 2025-06-30
项目状态：
未结题

项目摘要

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.

项目摘要/摘要厌食症（AN）是一种昂贵且威胁生命的疾病。经常在急性设置，但是治疗后退休很普遍。此外，急性设置中的放电标准为通常是重量恢复。但是，研究表明，基于体重的恢复不是“完全”的，并且完全恢复涉及身体，行为和心理成分。认知行为疗法（CBT）在该人群中很有用，包括后期出院，可能有助于解决心理症状，实现完全恢复和减少继电器。但是，很少有患者可以使用提供了这些技术培训的提供商。 MHealth Technologies具有指数增长的巨大潜力通过解决治疗的障碍，可以获取高质量的服务，以供急性治疗。日期，对这些方法的研究非常有限。我们的团队成功地开发了基于自助CBT的指导性移动应用程序，学生源疾病（SB-ED），已证明具有暴饮暴及型的大学妇女的有效性。同时，我们已经证明了支持面对面的CBT，以预防成人后急性护理和救济。总体目标该R34是开发和测试一个基于CBT的教练移动应用程序，以解决急性后的护理和接力赛基于以下方面的预防AN：1）我们自己的应用程序，用于处理暴饮暴食/清除型型； 2）我们在 - 人使用CBT来急性护理AN； 3）研究具有很高理论的其他功能在急性后时期支持具有的个人的潜力，这是一项社交网络功能，可提供与具有共同经验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顾问委员会的指导下，我们将适应现有的SB-ED应用程序的工作人口并添加社交网络功能。然后，我们将通过三个进一步完善干预措施 n = 20的可用性测试回合。在AIM 2中，我们将进行一项飞行员随机对照试验（n = 90）移动干预与移动干预加上社交网络与治疗照照（tau）。我们将估计移动干预的初步可行性和有效性移动干预加上社交网络与tau在减少ED心理病理学方面（主要结果），减少ED行为，维持体重维持，减少抑郁和自杀想法，并减少临床障碍。我们还将检查移动干预是否改变了提议的目标以及目标的变化是否与临床益处相关，并进行探索性分析以识别APP内预测因子和结果的主持人。效应大小和属性估计将有助于在计划R01随机对照试验的计划中，我们将大规模测试该应用程序，从而带给我们更接近我们的目标是增加对AN和AN和最终阻止这种致命疾病可能造成的极端负面后果。