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.

项目总结/摘要 进食障碍（ED）是慢性和致残性的;大多数人从未达到完全缓解， 即使经过强化治疗，50%接受强化治疗的患者会复发 出院后6个月内。这些高复发率经常发生，并导致穷人 在ED中看到的结果。重要的是，现有治疗与对照治疗在以下方面没有差异： 改变认知艾德病理学的能力，这是主要的剩余病理学， 从重症监护室出院迫切需要艾德预防复发的治疗方法， 扰乱了入院和出院的持续循环， 明确针对核心认知情感病理。我们的科学前提， 我们过去的工作是，在线暴露协议的应用将使恐惧消失- 改善结果，促进完全康复，降低复发的可能性。我们 研究目标是（1）开发和测试的可接受性，可行性，和初步的疗效， 随机化的在线暴露复发预防协议，可以提供后， 急性治疗与书写控制治疗的比较，以及（2）测试这种治疗是否针对恐惧 消退，这是艾德认知情感病理学的核心方面。这些目标最终将 导致针对核心艾德机制高度可部署和可访问的在线治疗。 拟议的研究使用高度创新的方法;我们将使用一种全远程技术- 基于方法，将在线治疗与评估目标的移动的技术相结合 恐惧灭绝。在线治疗与移动的评估相结合， 第一次，创造一个参与和有针对性的治疗，这可以迅速 在护理的关键时期传播。具体目标是：（1）收集以下方面的初步数据： 出院后两种治疗条件随机化的可行性和可接受性 强化艾德治疗：一项预防复发的在线暴露方案（n=65; ROEP）， 对照治疗书写条件（n=65）（2）为了测试ROEP和 预防复发的控制治疗和临床艾德结局的初步改变 (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 和艾德结果，以及（3b）测试恐惧条件反射的基线差异是否与变化有关 艾德的治疗结果。这项研究具有临床意义。最终这 建议将直接导致创建和传播一个高度用户友好， 可获得和可部署的干预措施，可以防止ED复发，这将减少 死亡率、发病率以及与慢性治疗相关的高成本。

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.

• DOI: 10.1002/eat.23603
• 发表时间: 2021-11
• 期刊: INTERNATIONAL JOURNAL OF EATING DISORDERS
• 影响因子: 5.5
• 作者: Levinson, Cheri A.;Ralph-Nearman, Christina;Brown, Mackenzie L.;Gardner, Taylor;Cardi, Valentina;Treasure, Janet;Purves, Kirstin;Eley, Thalia C.
• 通讯作者: Eley, Thalia C.