A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change

针对饮食失调和变化机制的复发预防在线暴露协议的试点随机对照试验

• 批准号: 10579874
• 负责人: Cheri Alicia Levinson
• 金额: $ 22.95万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10579874
• 关键词: Acute; Address; Admission activity; Adult; Affective; Aftercare; Anorexia Nervosa; Anxiety; Behavior; Behavioral; Bulimia; Caring; Cellular Phone; Chronic; Clinical; Cognition; Cognition Disorders; Cognitive; Communities; Data; Diagnosis; Diagnostic; Dimensions; Disease remission; Eating Disorders; Exhibits; Extinction; Food; Fright; Goals; Hospitalization; Hospitals; Individual; Inpatients; Intensive Care; Intervention; Lead; Learning; Literature; Measures; Medical; Mental disorders; Methods; Morbidity - disease rate; Outcome; Participant; Pathology; Prevention Protocols; Prevention program; Protocols documentation; Randomized; Randomized, Controlled Trials; Recovery; Relapse; Research; Self-Examination; Service delivery model; Severities; Shapes; Symptoms; Technology; Technology Assessment; Testing; Time; Treatment Efficacy; Treatment outcome; United States National Institutes of Health; Validation; Variant; Weight; Weight Gain; Work; Writing; acceptability and feasibility; conditioned fear; cost; cost outcomes; critical period; dietary restriction; efficacy validation; evidence base; hospital readmission; improved outcome; individual variation; innovation; medical complication; mobile computing; mortality; prevent; public health relevance; recruit; relapse prediction; relapse prevention; remote therapy; severe mental illness; smartphone application; smartphone based assessment; symptomatology; targeted treatment; therapy design; user-friendly; weight loss intervention

PROJECT SUMMARY/ABSTRACT Eating disorders (EDs) are chronic and disabling; most individuals never achieve full remission, even after intensive treatment, and 50% of those who access intensive treatment will relapse within 6-months of discharge. These high relapse rates occur often and contribute to the poor outcomes seen in EDs. Importantly, existing treatments to not differ from control treatments in the ability to alter cognitive ED pathology, which is the primary remaining symptomatology at discharge from intensive care. ED relapse-prevention treatments are urgently needed that can disrupt the persistent cycle of admission and discharge from intensive treatment and that are explicitly targeted at core cognitive-affective pathology. Our scientific premise, developed from our past work, is that the application of an online exposure protocol will engage fear extinction - improving outcomes, enhancing full recovery, and decreasing the likelihood of relapse. Our study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of an online exposure relapse-prevention protocol that can be delivered post- acute treatment versus a writing control treatment and (2) to test if this treatment targets fear extinction, which is a core aspect of ED cognitive-affective pathology. These goals will ultimately lead to a highly deployable and accessible online treatment targeted at core ED mechanisms. The proposed research uses highly innovative methods; we will use an all remote technology- based approach, combining an online treatment with mobile technology that assesses the target of fear extinction. The combination of an online treatment with mobile assessment allows, for the first time, the creation of an engaged and targeted treatment, which can rapidly be disseminated during a critical period of care. Specific aims are to (1) collect preliminary data on the feasibility and acceptability of the randomization of two treatment conditions after discharge from intensive ED treatment: a relapse-prevention online exposure protocol (n=65; ROEP) and a control treatment writing condition (n=65) (2) To test for differences between ROEP and control treatment for the prevention of relapse and preliminary change on clinical ED outcomes (3) To examine if ROEP targets fear extinction and if fear extinction is associated with relapse and ED outcomes, and (3b) To test if baseline differences in fear conditioning relate to change in ED outcomes across treatment. The proposed research has clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of a highly user-friendly, easily accessible and deployable intervention that can prevent relapse in the EDs, which will decrease mortality, morbidity, and the high costs associated with chronic treatment.

项目概要/摘要 饮食失调 (ED) 是慢性且致残的；大多数人从未达到完全缓解， 即使经过强化治疗，50%接受强化治疗的人也会复发 出院后 6 个月内。这些高复发率经常发生，并导致穷人 急诊室中看到的结果。重要的是，现有的治疗方法与对照治疗方法没有什么不同 改变认知 ED 病理学的能力，这是 ED 的主要剩余症状 从重症监护室出院。迫切需要预防 ED 复发的治疗方法 扰乱重症治疗入院和出院的持续循环， 明确针对核心认知情感病理学。我们的科学前提源自 我们过去的工作是，应用在线暴露协议将消除恐惧 - 改善结果、促进完全康复并降低复发的可能性。我们的 研究目标是（1）开发并测试一个方案的可接受性、可行性和初步有效性。 可以在事后交付的在线暴露复发预防方案的随机化 急性治疗与写作控制治疗，以及（2）测试这种治疗是否针对恐惧 消退，这是 ED 认知情感病理学的核心方面。这些目标最终将 导致针对核心 ED 机制的高度可部署和可访问的在线治疗。 拟议的研究采用了高度创新的方法；我们将使用全远程技术- 基于方法，将在线治疗与评估目标的移动技术相结合 的恐惧灭绝。在线治疗与移动评估相结合， 第一次创建一种参与性的、有针对性的治疗方法，可以迅速得到治疗 在关键护理时期传播。具体目标是 (1) 收集初步数据 出院后两种治疗条件随机化的可行性和可接受性 强化 ED 治疗：预防复发在线暴露方案（n=65；ROEP）和 对照治疗写作条件 (n=65) (2) 测试 ROEP 和 ROEP 之间的差异 预防复发和初步改变临床 ED 结果的控制治疗 (3) 检查ROEP是否针对恐惧消退以及恐惧消退是否与复发相关 和 ED 结果，以及 (3b) 测试恐惧调节的基线差异是否与变化相关 整个治疗过程中 ED 的结果。拟议的研究具有临床影响。最终，这 提案将直接导致创建和传播高度用户友好、易于使用的 可利用且可部署的干预措施可以防止急诊科复发，从而减少 死亡率、发病率以及与长期治疗相关的高费用。

项目成果

A pilot randomized control trial of online exposure for eating disorders and mechanisms of change delivered after discharge from intensive eating disorder care: A registered report.

一项针对饮食失调在线暴露以及从强化饮食失调护理出院后提供的变化机制的试点随机对照试验：一份注册报告。

• 发表时间: 2021-11
• 作者: Levinson, Cheri A;Ralph;Brown, Mackenzie L;Gardner, Taylor;Cardi, Valentina;Treasure, Janet;Purves, Kirstin;Eley, Thalia C
• 通讯作者: Eley, Thalia C