Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders R33 Phase

摘要 只有3%-20%的饮食失调患者接受了治疗，而且他们经常得不到证据- 基于治疗，因为这些治疗是密集和昂贵的，而且很少有临床医生提供这些治疗。这些因素有 阻碍了广泛的实施，这意味着对一系列急诊室的短暂一线门诊治疗可能 容易、廉价和广泛实施将解决一个关键的公共卫生问题。也有有限的 关于维持ED的因素和ED治疗的作用机制的实验数据。我们 假设ED是通过以下方式维持的：(1)对瘦理想的过度估值，这会引发卡路里 限制和其他不健康的体重控制行为(呕吐、使用泻药/利尿剂、过度运动) 这增加了暴饮暴食的风险，以及(2)对高卡路里食物的过度估值，从而维持了暴饮暴食 吃东西。我们建议评估一组有效地针对这两个维持因素的治疗。我们 创造了一种新的基于8个疗程的不和谐治疗(反态度疗法；CAT)，其中 与任何ED一起完成口头、书面和行为活动，在这些活动中他们讨论追求瘦的成本 理想和他们用来追求这种理想的ED行为，这可能会造成参与的不和谐 这些行为降低了瘦理想和高卡路里狂欢食品的价值。在两次试飞中，猫 减少对瘦模特和暴饮暴食的行为评估，以及盲目面试者评估的边缘 症状与非标准化(d=.94)和标准化的常规护理(d=.53)相比，到 在两个试验中随访2-6个月。效果大小与20个疗程产生的效果相比更有利 急诊室的个体化治疗。完成不和谐诱导活动的女性追求 瘦理想显示对瘦模型的fMRI评估的奖赏区域反应减少(Stices等人，2015) 提供了目标交战的进一步证据。R61随机试验(N=60)将(1)验证 CAT在对瘦模型的客观fMRI评估的奖赏区域反应中产生更大的岗位前减少 在患有DSM-5 ED的女性中，暴饮暴食(干预目标措施)与等待名单控制；(2) 生成关于减少ED症状域上的靶点的临床效果的初步数据 功能(结果)；以及(3)测试目标和结果的减少是否显示出线性下降 较早的8个课时或平台期，与更多的课时出勤率和家庭作业完成情况相关，以 检查剂量-反应关系。如果R61确认CAT与干预目标充分接触，并且 8个疗程的形式产生最佳反应，全功率R33随机试验(N=120)将测试 CAT是否比普通护理组在两个功能磁共振评估目标上产生了更大的减少 治疗；(5)与常规护理相比，CAT在ED症状和功能障碍方面的减少幅度更大 通过6个月的随访进行治疗；以及(6)靶点的变化与ED症状和 发挥作用，并调节对结果的干预效果。

ABSTRACT Only 3-20% of people with eating disorders (EDs) receive treatment, and they often do not receive evidence- based treatments because they are intensive and costly, and few clinicians deliver them. These factors have hindered broad implementation, implying that a brief frontline outpatient treatment for a range of EDs that could be easily, cheaply, and widely implemented would address a key public health problem. There are also limited experimental data regarding factors that maintain EDs and mechanisms of action for ED treatments. We hypothesize that EDs are maintained by (1) excessive valuation of the thin ideal, which prompts caloric restriction and other unhealthy weight control behaviors (vomiting, laxative/diuretic use, excessive exercise) that increase risk for binge eating, and (2) excessive valuation of high-calorie foods, which maintains binge eating. We propose to evaluate a group treatment that efficiently targets these 2 maintenance factors. We created a novel 8-session dissonance-based treatment (Counter Attitudinal Therapy; CAT) wherein women with any ED complete verbal, written, and behavioral activities in which they discuss costs of pursuing the thin ideal and the ED behaviors they use to purse this ideal, which putatively creates dissonance about engaging in these behaviors that reduces valuation of the thin ideal and high-calorie binge foods. In two pilot trials CAT reduced behaviorally-assessed valuation of thin models and binge foods, and blinded interviewer-assessed ED symptoms versus unstandardized (d=.94) and standardized usual care (d=.53), resulting in a 70% remission by 2-6 month follow-up across the two trials. Effect sizes compare favorably to those produced by 20-session individual therapies for EDs. Women who completed the dissonance-inducing activities regarding pursuit of the thin ideal showed a reduction in fMRI-assessed reward region response to thin models (Stice et al., 2015) providing further evidence of target engagement. The R61 randomized trial (N=60) will (1) validate whether CAT produces larger pre-post reductions in objective fMRI-assessed reward region response to thin models and binge foods (intervention target measures) versus waitlist controls in women with DSM-5 EDs; (2) generate preliminary data regarding the clinical effects of reducing the targets on ED symptom domains and functioning (outcomes); and (3) test whether reductions in targets and outcomes show a linear decrease over the 8 sessions or plateau earlier and correlate with greater session attendance and homework completion, to examine dose-response relations. If the R61 confirms that CAT sufficiently engages intervention targets and that the 8-session format produces optimal response, the fully-powered R33 randomized trial (N=120) will test whether (4) CAT produces greater reductions in the two fMRI-assessed targets than a usual care group treatment; (5) CAT produces greater reductions in ED symptoms and functional impairment than the usual care treatment through 6-month follow-up; and (6) change in targets correlates with change in ED symptoms and functioning, and mediates intervention effects on outcomes.