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

描述（由申请人提供）：没有单一的常规治疗已被证明对患有神经性厌食症（AN）的成年人有显著的益处，这是年轻女性残疾和过早死亡的主要原因之一。我们建议检验以下假设：根据RFA-MH-07-090开发的针对成人AN的新型、基于夫妇的干预（UCAN [联合夫妇（治疗）神经性厌食症]）与完全基于个体的治疗（社区治疗的标准模式）相比，显著增强了治疗结果并降低了复发风险。本申请是为了响应PA-10-067研究项目资助（父R 01）而提交的，将进一步确定UCAN的疗效。UCAN使患者和合作伙伴相互参与，以减少AN的精神病理学及其对关系功能的影响。我们的试验结果令人鼓舞-体重显著增加和前所未有的低治疗脱落-支持这一应用。为了确定UCAN是否上级单独的个体治疗，我们提出了一项随机对照试验，比较：1）UCAN+个体认知行为治疗（UCAN+CBT）和2）个体CBT。所有患者都接受与常规AN治疗相同的核心干预措施，具体而言：1）医疗管理，2）营养咨询，3）个体CBT。此外，参与者将被随机分配到：1）UCAN或2）更高“剂量”的个体CBT。该设计解决了一个问题的临床，发展和概念的重要性，迄今尚未探讨：是治疗成人AN优化时，它包括积极参与患者的合作伙伴，与社区标准的个人治疗。主要目的是比较UCAN+CBT与个体CBT在以下方面的疗效：1）增加BMI并改善总体临床改善，2）增加治疗保留率和满意度。探索性目的将解决以下问题：1）是否存在证据表明，主要结局变量的改善可能部分由关系功能和患者改变准备程度的改善介导; 2）在后续试验中，应将疾病持续时间、亚型（限制与狂欢/净化）和情绪失调的基线水平视为治疗结局的候选调节因素。我们将收集数据，以指导设计更全面的成本效益分析，如果随后的多中心试验是必要的。主要结局是BMI的变化、总体改善、保留和治疗满意度。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随访。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明确的试验，并为指导成人AN治疗的治疗观点提供信息。成人AN的创新，有效的治疗方法的发展是必不可少的，以减少慢性发病率，死亡率高的风险，以及大量的个人，家庭和公共卫生负担所造成的这种衰弱和顽固的疾病。

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.