2/2-Adaptive Family Treatment for Adolescent Anorexia Nervosa

描述（由申请方提供）：神经性厌食症（AN）是一种严重疾病，与显著的精神和医学发病率和死亡率以及由于使用强化治疗而导致的高治疗成本相关。有证据表明，FBT对青少年AN是一种有效的门诊治疗，无论是在治疗结束时还是4-5年的随访。使用FBT，约50%的参与者在治疗后缓解（%IBW>95 + EDE >平均值的1 SD），90%的参与者在治疗后完全缓解，在12个月随访时保持不变。相比之下，在治疗后未完全缓解的患者中，有75%在随访时仍未缓解。由于成人AN没有已知的有效治疗方法，而青少年AN似乎对治疗更敏感，因此改善该年龄组结局的努力对于预防慢性和持续病程的发展至关重要。然而，当对FBT的反应不充分时，通常建议进行更密集的程序化治疗（例如日间治疗，住院治疗或精神病住院治疗）。尽管这些方案的普遍使用，现有数据并不表明这些干预措施比青少年门诊干预措施更有效。改善那些对FBT没有反应的人的结果的另一种策略是直接向家庭本身提供额外的和有针对性的门诊帮助。数据表明，不太可能在FBT中成功的家庭可以在治疗后一个月内被识别出来。因此，在治疗过程的早期提供替代疗法可能会改善总体结局。为了开发一种新的治疗-强化家庭集中治疗（IFT），以改善对FBT没有早期反应的患者的结局，我们提出了一项2期治疗开发研究，其目的是（1）确定干扰实现体重恢复的可改变的家庭因素/行为，（2）发展一种新的家庭治疗（IFT），针对无益行为，促进有益行为（1期-迭代病例系列（n=40））和（3）初步IFT（对于那些对FBT没有早期反应的人）与FBT单独在一个小型RCT中，（4）探索家族和个体因素作为预测因子，调节因子，和治疗介质（2期-小型RCT（n=50））。为了实现这些目标，本研究将在两个研究中心招募90名AN（DSM-IV，不包括闭经）青少年及其家人（45名参与者来自芝加哥大学，45名来自斯坦福大学）。主要结局将是AN的完全缓解（%IBW>95 + EDE >平均值的1 SD）。将在基线和治疗结束时评估主要结局以及潜在预测因子、调节因子和介导因子，包括父母和子女的进食相关精神病理学（进食障碍检查）、耶鲁-布朗-康奈尔-进食障碍、身高/体重、父母和子女的一般精神病理学、家庭状况和家庭功能。 公共卫生相关性：与任何其他精神疾病相比，神经性厌食症（AN）的死亡率最高。最有希望的治疗青少年与AN是家庭为基础的治疗（FBT）。然而，只有50%接受FBT的患者在12个月随访时完全缓解。因此，在治疗过程的早期为那些对FBT无反应的患者提供替代疗法可能会改善总体结局。本研究旨在开发一种新的治疗方法-强化家庭集中治疗（IFT）-以改善12-18岁青少年的结局，这些青少年对FBT没有早期反应。

DESCRIPTION (provided by applicant): Anorexia Nervosa (AN) is a serious disorder associated with significant psychiatric and medical morbidity and mortality and high treatment costs due to the use of intensive treatment. Evidence suggests that FBT for adolescent AN is an effective outpatient treatment both at the end of treatment and 4-5 year follow-up. Using FBT, about 50% of participants remit (%IBW>95 + EDE >1SD of the mean) and 90% of those fully remitted at post-treatment, remain so at 12-month follow-up. In contrast, 75% of those not fully remitted at post-treatment are still not remitted at follow-up. Because there are no known effective treatments for adults with AN, and adolescents with AN appear to be more responsive to treatment, efforts to improve outcomes in this age group are critical to prevent the development of a chronic and unremitting course. However, when response to FBT is inadequate, more intensive programmed treatment (e.g. day treatment, residential care, or psychiatric hospitalization) is often recommended. Despite the common use of such programs, available data do not suggest that these interventions are more effective than outpatient interventions in adolescents. An alternative strategy to improve outcomes for those that do not respond to FBT would be to provide additional and targeted outpatient help directly to families themselves. Data suggest that families that are not likely to be successful in FBT can be identified as early as one month into treatment. Consequently, providing an alternative therapy early in the treatment course may enhance overall outcome. To develop a new treatment - Intensive Family-Focused Treatment (IFT) to improve outcomes in those who do not show an early response to FBT we propose a 2-phase treatment development study which aims to (1) identify modifiable family factors/behaviors that interfere with accomplishing weight restoration, and (2) develop a new family treatment (IFT) targeting unhelpful behaviors and promoting helpful ones (Phase 1 - Iterative case series (n=40)), and (3) pilot IFT (for those not responding early to FBT) vs. FBT alone in a small RCT, and (4) explore familial and individual factors as predictors, moderators, and mediators of treatment (Phase 2 - Small RCT (n=50)). To achieve these aims, this study will recruit 90 adolescents with AN (DSM-IV, exclusive of amenorrhea) and their families at two sites (45 participants at The University of Chicago and 45 at Stanford University). Primary outcome will be full remission from AN (%IBW>95 + EDE >1SD of the mean). Assessment of primary outcome as well as potential predictors, moderators and mediators will occur at baseline and at the end of treatment and will include eating related psychopathology in the parent and child (Eating Disorder Examination), Yale- Brown-Cornell-Eating Disorder, height/weight, general psychopathology in parent and child, family status, and family functioning. PUBLIC HEALTH RELEVANCE: Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-moth follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.