2/2-Treatment of Adolescent Bulimics

描述（由申请人提供）：神经性贪食症（BN）是一种严重的疾病，其特征是对体重和体型的高估，以及由极端节食和暴饮暴食和排便组成的不受抑制的饮食模式。BN发生在大约1-2%的青少年人群中，而临床显著的暴食行为或部分BN（具体定义为平均每周至少一次，持续6个月）发生在另外2-3%的人群中。然而，除了暴饮暴食和排便行为的频率外，完全综合征BN和部分综合征BN的临床严重程度似乎没有什么差异。虽然暴食症通常发生在青春期，但只有两项已发表的随机临床试验（rct）研究了该年龄组的治疗方法。我们最近发表的青少年BN的随机对照试验结果表明，家庭治疗（FBT-BN）对青少年BN的治疗效果优于个体治疗。此外，最近发表的病例系列报告表明，针对青少年的CBT （CBT- a）是治疗该年龄组暴食症的一种有希望的治疗方法。目标1：比较CBT-A和FBT-BN在减少BN和部分BN青少年暴饮暴食和排泻发作方面的疗效（定义为过去六个月每周至少一次暴饮暴食和排泻）。我们预测随机分配到CBT-A组的受试者实现戒断（通过饮食失调检查评估）的比率明显高于接受FBT- BN组的受试者。目的2：探索结果的潜在调节因子。我们预测，基线时的症状严重程度将缓和预后；具体而言，那些症状严重程度较高（EDE分量表得分较高）的受试者使用CBT-A比使用FBT-BN有更好的结果。目的3：探索结果的潜在中介。我们预测，ed - q的约束分量表的早期变化将调节两种治疗的结果。目标4：如果两种特定治疗之间没有差异，我们将探索特异性治疗（CBT-A和FBT-BN）与非特异性治疗（支持性心理治疗- SPT）之间的禁欲差异，以检查非特异性治疗效果（时间的推移和非特异性治疗影响）。为了实现这些目标，提出了以下两点研究：158名年龄在12-18岁之间符合DSM- IV标准的BN或部分BN的青少年（每个地点79人）将被随机分为CBT-A（66名受试者），FBT-BN（66名受试者）或SPT（26名受试者），这是一种针对BN的非特异性治疗，为期20个疗程/ 6个月的治疗期。该研究的主要目的是分析比较两种特定治疗（FBT-BN和CBT-A）；然而，我们将一个较小的队列随机分配到SPT，以便在两种特定治疗之间没有发现差异的情况下，对非特异性治疗因素进行事后检查。

DESCRIPTION (provided by applicant): Bulimia Nervosa (BN) is a serious disorder characterized by overvalued ideas concerning body weight and shape and disinhibited eating patterns consisting of extreme dieting followed by binge eating and purging. BN occurs in approximately 1-2% of the adolescent population, while clinically significant bulimic behaviors or partial BN (specifically defined as binge eating and purging on average at least once a week for six months) occur in an additional 2-3%. However, other than frequency of binge eating and purging behaviors there appear to be few differences in the clinical severity of those with full syndrome BN and those with partial BN. Although bulimic behaviors typically onset during adolescence, there are only two published randomized clinical trials (RCTs) examining treatments for this age group. Results from our own recently published RCT of adolescent BN using a form of family-based therapy (FBT-BN) has shown that FBT-BN is superior to individual therapy for adolescents with BN. Also, recently published case series reports suggest that CBT adjusted for adolescents (CBT-A) is a promising treatment for bulimia in this age group. The Specific Aims of the proposal are: Aim 1: To compare the efficacy of CBT-A to FBT-BN in decreasing binge eating and purging episodes in adolescents with BN and partial BN (defined as binge eating and purging at least one time per week for the past six months). We predict that subjects randomized to CBT-A will achieve abstinence (as assessed by the Eating Disorder Examination) at significantly higher rates than those who receive FBT- BN. Aim 2: To explore potential moderators of outcome. We predict that symptom severity at baseline will moderate outcome; specifically, those subjects with greater symptom severity (higher EDE subscale scores) will have better outcomes with CBT-A than FBT-BN. Aim 3: To explore potential mediators of outcome. We predict that early changes in the restraint subscale of the EDE-Q) will mediate outcome in both treatments. Aim 4: If there are no differences between the two specific treatments, we will explore abstinence differences between specific treatments (CBT-A and FBT-BN) compared to a non-specific treatment (Supportive Psychotherapy - SPT) in order to examine nonspecific treatment effects (passage of time and nonspecific therapeutic influences). To accomplish these aims the following two-site study is proposed: 158 adolescents (79 at each site) between the ages of 12-18 years who meet DSM- IV criteria for BN or partial BN will be randomized to CBT-A (66 subjects), FBT-BN (66 subjects) or SPT (26 subjects), a non-specific treatment for BN for a 20 session/six month treatment period. The study is powered for the analysis of the primary aim of comparing the two specific treatments (FBT-BN and CBT-A); however, we are randomizing a smaller cohort to SPT to allow a post-hoc examination of non-specific treatment factors should no differences be found between the two specific treatments.