A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents with Low Weight Eating Disorders

内感受暴露对低体重饮食失调青少年的有效性研究

• 批准号: 10571565
• 负责人: THOMAS B HILDEBRANDT
• 金额: $ 78.62万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10571565
• 关键词: Abbreviations; Address; Adolescence; Adolescent; Aftercare; Age; Anorexia Nervosa; Attitude; Awareness; Behavioral; Blinded; Body Weight; Child; Child Rearing; Chronic; Clinical; Cost of Illness; Cues; Data; Data Analyses; Development; Distal; Eating; Eating Behavior; Eating Disorders; Electrophysiology (science); Eligibility Determination; Etiology; Evaluation; Exposure to; Extinction; Family; Family psychotherapy; Food; Foundations; Health Care Costs; Impairment; Intervention; Laboratories; Learning; Measures; Mediating; Mediation; Mediator; Meta-Analysis; Modeling; Occupations; Outcome; Participant; Pathology; Patients; Pharmaceutical Preparations; Protocols documentation; Public Health; Publishing; Randomized Controlled Clinical Trials; Self Efficacy; Shapes; Symptoms; Testing; Time; Treatment Efficacy; Weight; aged; comparative efficacy; conditioning; confirmatory trial; depressive symptoms; efficacy evaluation; efficacy study; efficacy testing; efficacy trial; experience; feeding; follow-up; food avoidance; improved; learning extinction; longitudinal dataset; novel; primary outcome; secondary outcome; severe psychiatric disorder; sex; standard care; success; systematic review; treatment adherence; treatment comparison; treatment effect; treatment response

Project Summary/Abstract Low weight eating disorders, such as anorexia nervosa/atypical anorexia nervosa, are severe psychiatric disorders that often develop in adolescence, have a chronic course, and evidence poor response to treatment at great public health cost. Two core features of LW-EDs are food avoidance and preoccupation with shape and weight. Preliminary data from our initial mechanism study indicate that family based interoceptive exposure (FBT-E) therapy reduces food avoidance, increases autonomous eating and nonjudgement body awareness, and enhances extinction learning to aversive food cues to a greater degree than existing family- based therapy (FBT). Feasibility data indicated high retention, treatment fidelity, and established reliable measures of treatment adherence despite similar short-term (6-week) within-treatment changes in expected body weight. Long-term (6-month) follow-up of these interventions in open trial indicate significantly higher expected body weight among those having received FBT-E. Short-term and long-term changes in weight were highly correlated with changes in expected body weight. Consequently, we will test the confirmatory efficacy of FBT-E vs FBT and 12-month follow-up in a parallel group randomized clinical controlled trial in 120 adolescents aged 12-18. We have three specific aims, including: (1) to determine short term and long term efficacy of FBT-E vs FBT in expected body weight, global eating disorder symptoms, and clinical impairment; (2) to determine efficacy of FBT-E vs. FBT on laboratory measures of autonomous eating, nonjudgmental body awareness, and extinction learning; and (3) estimate whether temporal precedence and mechanistic value (mediation) of early changes in autonomous eating, non-judgmental body awareness, and extinction learning on treatment effects and longitudinal outcomes. Assessments and data analyses will be blinded to treatment. With N=120 participants (n = 60 per group) we can detect moderate sized effects for primary and secondary outcomes. Results will provide data to support novel treatment for LW-EDs and provide theoretical robust model for understanding pathology for children and families that suffer with LW-EDs.

项目摘要/摘要 低体重进食障碍，如神经性厌食症/非典型神经性厌食症，是严重的精神疾病。 通常在青春期发展的疾病，具有慢性病程，并且有证据表明对治疗的反应很差 以巨大的公共卫生成本。LW-EDS的两个核心特征是避免食物和专注于形状 和体重。我们初步机制研究的初步数据表明，基于家庭的内感 暴露(FBT-E)疗法减少了对食物的回避，增加了自主进食和非判断性身体 意识，并在更大程度上增强对有害食物线索的灭绝学习-- 基础疗法(FBT)。可行性数据表明，高保留率、治疗保真度和建立的可靠性 尽管预期的治疗内短期(6周)变化，但治疗依从性的衡量标准 体重。在开放试验中，这些干预措施的长期(6个月)随访显示显著更高 接受FBT-E治疗的人的预期体重。体重的短期和长期变化是 与预期体重的变化高度相关。因此，我们将测试 120例平行组随机临床对照试验中FBT-E与FBT的比较及12个月的随访 12-18岁的青少年。我们有三个具体目标，包括：(1)确定短期和长期 FBT-E与FBT在预期体重、全球进食障碍症状和临床损害方面的疗效比较； (2)确定FBT-E与FBT对自主进食、非判断性身体实验室测量的有效性 意识和灭绝学习；以及(3)估计时间优先和机械价值 (调解)自主饮食、非判断性身体意识和消亡学习的早期变化 关于治疗效果和纵向结果。评估和数据分析将对治疗视而不见。 对于N=120名参与者(每组60名)，我们可以检测到主要和次要影响的中等大小 结果。研究结果将为LW-EDS的新治疗提供数据支持，并提供可靠的理论依据 为患有LW-EDS的儿童和家庭理解病理学的模型。