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、暴饮暴食和腹泻组成的无节制饮食模式。BN发生在大约1-2%的青少年人群中，而临床上显著的暴食行为或部分BN（具体定义为平均每周至少一次，持续六个月的暴食和清洗）发生在另外2- 3%的人群中。然而，除了暴饮暴食和排泄行为的频率外，完全BN综合征和部分BN综合征的临床严重程度似乎没有什么差异。虽然暴食行为通常在青春期发作，但只有两项已发表的随机临床试验（RCT）检查了该年龄组的治疗方法。我们自己最近发表的青少年BN的随机对照试验结果表明，采用一种形式的家庭为基础的治疗（FBT-BN）是上级优于个别治疗青少年BN。此外，最近发表的病例系列报告表明，针对青少年调整的CBT（CBT-A）是该年龄组暴食症的有希望的治疗方法。该提案的具体目的是：目的1：比较CBT-A与FBT-BN在减少BN和部分BN青少年（定义为过去六个月每周至少一次暴食和清洗）中的暴食和清洗事件方面的疗效。我们预测，随机分配到CBT-A组的受试者将以显著高于接受FBT-BN组的受试者的比率实现禁欲（通过进食障碍检查评估）。目的2：探索潜在的结果调节因子。我们预测，基线时的症状严重程度将中度结局;具体而言，症状严重程度较高（EDE子量表评分较高）的受试者使用CBT-A的结局优于FBT-BN。目的3：探索潜在的结果介质。我们预测，早期变化的约束分量表的EDE-Q）将介导的结果在这两种治疗。目标4：如果两种特定治疗之间没有差异，我们将探索特定治疗（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，提出了以下两个研究中心的研究：将158名年龄在12-18岁之间、符合BN或部分BN的DSM- IV标准的青少年（每个研究中心79名）随机分配至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，治疗期为20个疗程/6个月。本研究具有分析比较两种特定治疗（FBT-BN和CBT-A）的主要目的的把握度;然而，我们将一个较小的队列随机分配至SPT，以便在两种特定治疗之间未发现差异时对非特定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.