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.

项目概要/摘要 低体重饮食失调，例如神经性厌食症/非典型神经性厌食症，是严重的精神疾病 通常在青春期出现的疾病，有慢性病程，并且对治疗的反应不佳 以巨大的公共卫生成本为代价。 LW-ED 的两个核心特征是回避食物和关注形状 和重量。我们初步机制研究的初步数据表明，基于家庭的内感受 暴露（FBT-E）疗法减少食物回避，增强自主进食和不评判身体 意识，并比现有家庭更大程度地增强对厌恶食物线索的灭绝学习 基于治疗（FBT）。可行性数据表明高保留率、治疗保真度，并建立了可靠的 尽管预期的短期（6周）治疗内变化相似，但治疗依从性的衡量标准 体重。开放试验中这些干预措施的长期（6 个月）随访表明， 接受 FBT-E 的人的预期体重。体重的短期和长期变化 与预期体重的变化高度相关。因此，我们将测试验证功效 FBT-E 与 FBT 对比以及 120 名受试者参加的平行组随机临床对照试验中的 12 个月随访 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、整体饮食失调症状和临床损伤方面的疗效； (2) 确定 FBT-E 与 FBT 对自主饮食、非评判性身体实验室测量的功效 意识和灭绝学习； (3) 估计时间优先级和机械价值是否 （调解）自主饮食、非评判性身体意识和灭绝学习的早期变化 关于治疗效果和纵向结果。评估和数据分析将对治疗不知情。 对于 N=120 名参与者（每组 60 名），我们可以检测到主要和次要的中等程度的影响 结果。结果将为支持 LW-ED 的新治疗方法提供数据，并提供稳健的理论 理解患有 LW-ED 的儿童和家庭的病理学模型。