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被证明对神经性厌食症（AN）的成年人有显著的益处，这是导致年轻女性残疾和过早死亡的主要原因之一。我们建议验证这样一个假设，即在RFA-MH-07-090下开发的一种针对成人厌食症的新型夫妇干预（UCAN[联合夫妇（治疗）神经性厌食症]），与完全以个人为基础的治疗（社区治疗的标准模式）相比，显著提高了治疗效果，降低了复发风险。本申请为回应PA-10-067研究计划拨款（家长R01）而提交，将进一步确立UCAN的效力。UCAN使患者和合作伙伴共同参与减少AN的精神病理及其对关系功能的影响。令人鼓舞的结果，从我们的试点-显著的体重增加和前所未有的低治疗退出-支持这一应用。为了确定UCAN是否优于单独的个体治疗，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。所有患者都接受与传统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，以及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。该设计解决了一个临床、发展和概念重要性的问题，迄今为止尚未被探索：当包括患者伴侣的积极参与时，与仅个体治疗的社区标准相比，成人a的治疗是否优化？主要目的是比较UCAN+CBT与单独CBT在以下方面的疗效：1)增加BMI和改善整体临床改善；2)增加治疗的保留率和满意度。探索性目标将解决以下问题：1)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意愿的改善介导；2)病程、亚型（限制与暴食/净化）和情绪失调基线水平应被视为后续试验中治疗结果的候选调节因子。我们将收集数据，以指导设计更全面的成本效益分析，如果后续的多地点试验是有必要的。主要结局是BMI的改变、整体改善、保留率和治疗满意度。我们将招募50对夫妇（40名完成者），随访时间超过3.75年，所有患者随访1年。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。该试验的结果将指导未来更明确的试验，并为指导成人AN的治疗提供治疗观点。开发创新的、有效的成人AN治疗方法对于减少慢性发病率、高死亡率以及这种使人衰弱和难以治愈的疾病给个人、家庭和公共卫生带来的沉重负担至关重要。

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.