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

• 批准号: 10452653
• 负责人: Ellen E. Fitzsimmons-Craft
• 金额: $ 24.42万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10452653
• 关键词: Acute; Address; Adult; Affect; Aftercare; Age; Ambulatory Care; Anorexia Nervosa; Behavior; Behavioral; COVID-19; Clinical; Cognitive Therapy; Continuity of Patient Care; Data; Development; Disease; Eating Disorders; Effectiveness; Employee; Ensure; Evidence based treatment; Feeling suicidal; Goals; Health; Health Technology; Impairment; Improve Access; Individual; Intervention; Life; Logistics; Mental Depression; Mental Health Services; Motivation; National Institute of Mental Health; Outcome; Outpatients; Participant; Patients; Persons; Population; Provider; Psychopathology; Randomized Controlled Trials; Recovery; Relapse; Research; Risk; Service delivery model; Services; Shapes; Social Network; Social support; Strategic Planning; Symptoms; Techniques; Technology; Testing; Time; Training; Weight; Woman; Work; acute care; barrier to care; base; college; cost; dietary; digital health; digital mental health; disorder later incidence prevention; experience; health care delivery; hospital readmission; illness length; improved; innovation; interest; mHealth; mobile application; pandemic disease; pilot test; prevent; primary outcome; psychologic; psychological symptom; purge; relapse patients; restraint; self help; service delivery; social media; treatment as usual; treatment center; usability; user centered design; weight maintenance; weight restoration

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，患有严重厌食症的患者通常需要在医院接受治疗。 急性情况，但治疗后复发很常见。此外，急性情况下的出院标准也很常见。 通常是体重恢复。然而，研究表明，基于体重的恢复是不够的，而且 完全康复涉及身体、行为和心理治疗。 （CBT）对于这一人群很有用，包括出院后，并且可能有助于解决心理问题 症状、实现完全康复并减少复发然而，很少有患者能够获得这种治疗。 经过这些技术培训的提供商具有呈指数级增长的巨大潜力。 通过解决治疗障碍，获得 AN 急性后治疗的高质量服务，但 迄今为止，对这些方法的研究极其有限，我们的团队已成功开发出一种方法。 基于 CBT 的引导式自助移动应用程序 StudentBodies-Eating Disorders (SB-ED)，已证明 同时，我们已经证明了对暴饮暴食型 ED 的大学女性的有效性。 支持成人 AN 的急性期后护理和复发预防的面对面 CBT 的总体目标。 R34 旨在开发和测试基于 CBT 的辅导移动应用程序，以解决急性后护理和复发问题 预防 AN，基于：1) 我们自己的应用程序用于治疗暴饮暴食/清除型 ED；2) 我们在以下方面的工作： 个人使用 CBT 进行 AN 急性期护理；以及 3) 对具有高理论性的附加功能的研究 在急性期后支持 AN 患者的潜力——一种社交网络功能，可提供 与具有共同经验的个人进行积极互动的机会。 在相关利益相关者的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 然后，我们将通过三个方面进一步细化干预。 总共 N=20 轮的可用性测试 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加社交与网络治疗的对比 （TAU）。我们将评估移动干预与传统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 精神病理学方面的比较（主要 结果），减少 ED 行为，实现体重维持，减少抑郁和自杀意念， 我们还将研究移动干预是否改变了拟议的方案。 目标以及目标的变化是否与临床获益相关，以及进行探索性研究 确定应用内结果预测因素和调节因素的分析将有助于确定效果大小和流失估计。 在 R01 随机对照试验的规划中，我们将更大规模地测试该应用程序，为我们带来 更接近实现我们的目标，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。