Enhancing Treatment for Adult Anorexia Nervosa with a Couple-Based Approach

描述(由申请人提供)：没有单一的传统治疗方法显示患有神经性厌食症(AN)的成年人显著受益，这是导致年轻女性残疾和过早死亡的主要原因之一。我们建议测试这一假设，即根据RFA-MH-07-090为成人AN(UCAN[联合夫妇(治疗)神经性厌食症])开发的一种新颖的、基于夫妇的干预措施与完全基于个人的治疗(社区标准治疗模式)相比，显著提高了治疗结果并降低了复发风险。这份申请是对PA-10-067研究项目资助(家长R01)的回应，将进一步确立UCAN的效力。UCAN使患者和伴侣相互参与，以减少AN的精神病理及其对关系功能的影响。我们试验的令人鼓舞的结果--显著的体重增加和前所未有的低治疗退出率--支持这一应用。为了确定UCAN是否优于单独治疗，我们提出了一项随机对照试验，比较：1)UCAN加个体化认知行为疗法(UCAN CBT)和2)个体化CBT。所有患者都接受常规AN治疗中使用的相同核心干预措施，特别是：1)医疗管理，2)营养咨询，3)个体化CBT。此外，参与者将被随机分配到：1)UCAN或2)更高剂量的单独CBT。该设计解决了一个迄今未被探索的临床、发育和概念重要性的问题：与社区标准的个体化治疗相比，当患者的伴侣积极参与时，成人的治疗是优化的吗？主要目的是比较UCAN CBT和单独CBT在以下方面的疗效：1)增加体重指数和改善整体临床改善；2)增加治疗的保留率和满意度。探索性目标将涉及：1)是否存在证据表明，主要结果变量的改善可能部分是由关系功能的改善和患者对变化的准备程度调节的；以及2)病程、亚型(限制与狂欢/清除)和情绪失调的基线水平是否应被视为后续试验中治疗结果的候选调节因素。我们将收集数据，以指导设计更全面的成本效益分析，如果随后的多个地点的试验是必要的。主要结果是体重指数的变化、整体改善、保留率和治疗满意度。我们将在3.75年内招募50对夫妇(40名完成者)，并对所有患者进行为期一年的跟踪调查。数据监测组(DMG)将监测招募、治疗保真度、评估和人类受试者保护。这项试验的结果将指导未来更具决定性的试验，并为指导成人AN的治疗提供信息。开发针对成人AN的创新、有效的治疗方法对于减少这种衰弱和顽固性疾病带来的慢性发病率、高死亡风险和巨大的个人、家庭和公共卫生负担至关重要。

DESCRIPTION (provided by applicant): No single, conventional treatment has been shown to significantly benefit adults with anorexia nervosa (AN), which ranks among the leading causes of disability and premature death in young women. We propose to test the hypothesis that a novel, couple-based intervention developed for adult AN (UCAN [Uniting Couples (in the treatment of) Anorexia Nervosa]) developed under RFA-MH-07-090 significantly enhances treatment outcome and reduces risk of relapse compared with treatment conducted entirely on an individual basis, the standard mode of treatment delivery in the community. This application, submitted in response to PA-10-067 Research Project Grant (Parent R01) will further establish the efficacy of UCAN. UCAN mutually engages patients and partners in reducing the psychopathology of AN and its impact on relationship functioning. Encouraging results from our pilot - significant weight gain and unprecedentedly low treatment drop out - support this application. In order to determine whether UCAN is superior to individual treatment alone, we propose a randomized controlled trial comparing: 1) UCAN plus individual cognitive-behavioral therapy (UCAN+CBT) to 2) Individual CBT. All patients receive the same core of interventions used in conventional AN treatment, specifically: 1) medical management, 2) nutrition counseling, and 3) individual CBT. Further, participants will be randomly assigned either to: 1) UCAN or 2) a higher "dose" of individual CBT. The design addresses a question of clinical, developmental, and conceptual importance heretofore unexplored: Is treatment of adult AN optimized when it includes active participation of the patient's partner, compared with the community standard of individual therapy only. The primary aims are to compare the efficacy of UCAN+CBT with Individual CBT in: 1) increasing BMI and improving global clinical improvement, and 2) increasing retention in and satisfaction with treatment. Exploratory aims will address whether: 1) evidence exists to suggest that improvement in primary outcome variables may be partially mediated by improvements in relationship functioning and patient readiness to change; and 2) illness duration, subtype (restricting vs. binge/purge), and baseline level of emotion dysregulation should be considered as candidate moderators of treatment outcome in subsequent trials. We will collect data to guide the design of a more comprehensive cost-effectiveness analysis if a subsequent multi-site trial is warranted. The primary outcomes are change in BMI, global improvement, retention, and treatment satisfaction. We will recruit 50 couples (40 completers) over 3.75 years and follow all patients for one year. The Data Monitoring Group (DMG) will monitor recruitment, treatment fidelity, assessments, and human subject protections. Results from this trial will guide future, more definitive trials and inform therapeutic perspectives guiding the treatment of adults with AN. The development of innovative, efficacious treatments for adult AN is essential to reducing the chronic morbidity, high risk of mortality, and substantial personal, familial, and public health burdens incurred by this debilitating and recalcitrant illness.