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

DSM-5 饮食失调 R33 阶段基于失调的新型治疗的目标参与

基本信息

批准号：
10868785
负责人：
ERIC M STICE
金额：
$ 56.29万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-10 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10868785
关键词：
Address Ambulatory Care Attitude Beauty Behavior Behavior Control Behavior Disorders Behavior assessment Behavioral Binge Eating Biological Blinded Caloric Restriction Calories Clinical DSM-V Data Dimensions Disease remission Diuretics Dose Eating Disorders Evidence based treatment Expectancy Food Functional Magnetic Resonance Imaging Individual Intervention Interviewer Investigational Therapies Knowledge Maintenance Measures Mediating Modality Modeling Outcome Participant Persons Persuasive Communication Phase Process Public Health Research Rewards Risk Site Specific qualifier value Standardization Surveys Symptoms Testing Therapeutic Thinness Time Translating Vomiting Waiting Lists Weight maintenance regimen Woman Writing alternative treatment arm clinical effect cost evidence base excessive exercise expectation follow-up functional disability intervention effect laxative novel pilot trial randomized trial response theories treatment as usual treatment duration treatment group verbal

项目摘要

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.

抽象的只有 3-20% 的饮食失调 (ED) 患者接受治疗，而且他们常常得不到证据—— 基础治疗，因为这些治疗强度大、成本高，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实施，这意味着对一系列急诊科进行短暂的一线门诊治疗可能会容易、廉价且广泛实施将解决一个关键的公共卫生问题。还有有限的关于维持 ED 的因素和 ED 治疗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) 对瘦理想的过度评估，这会促使热量消耗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）增加暴饮暴食的风险，以及（2）对高热量食物的过度评价，从而维持暴饮暴食吃。我们建议评估有效针对这两个维持因素的团体治疗。我们创造了一种新颖的 8 疗程失调疗法（反态度疗法；CAT），其中女性与任何 ED 一起完成口头、书面和行为活动，在活动中他们讨论追求瘦身的成本理想以及他们用来追求这一理想的 ED 行为，这可能会造成参与的不和谐这些行为降低了人们对瘦身理想和高热量暴饮暴食的评价。在两次 CAT 试点试验中减少对瘦模特和暴食行为的评估，以及对采访者进行盲态评估的 ED 与非标准化 (d=.94) 和标准化常规护理 (d=.53) 相比，症状缓解 70% 两项试验的 2-6 个月随访。效果大小与 20 次疗程产生的效果相比毫不逊色 ED 的个体化治疗。完成了有关追求“不和谐”的活动的女性薄理想显示出功能磁共振成像评估的奖励区域对薄模型的反应减少（Stice et al., 2015）提供目标参与的进一步证据。 R61 随机试验 (N=60) 将 (1) 验证是否 CAT 对瘦模型的客观 fMRI 评估的奖励区域反应产生更大的前后减少患有 DSM-5 ED 的女性的暴饮暴食（干预目标措施）与候补名单对照； (2) 生成有关减少 ED 症状领域目标的临床效果的初步数据，以及运作（结果）； (3) 测试目标和结果的减少是否显示出线性减少 8 节课或提早达到稳定状态，并与更多的课时出勤率和作业完成情况相关，检查剂量反应关系。如果 R61 确认 CAT 充分参与了干预目标并且 8 次会议的形式会产生最佳反应，全功率 R33 随机试验 (N=120) 将测试 (4) CAT 是否比常规护理组在两个功能磁共振成像评估目标方面产生更大的减少治疗; (5) CAT 比常规治疗更能减少 ED 症状和功能障碍通过 6 个月的随访进行治疗； (6) 目标的变化与 ED 症状的变化相关功能，并介导干预对结果的影响。