Addressing Weight History to Improve Behavioral Treatments for Bulimia Nervosa

 描述（由申请人提供）：目前的项目是一个重新提交的K23奖博士阿德里安娜Juarascio，在德雷克塞尔大学助理研究教授。Juarascio博士正在建立自己作为一个早期职业生涯的研究人员在以病人为导向的研究， 专注于饮食失调症的创新治疗开发。特别是，Juarascio博士对使用实验治疗方法来改善现有治疗方法的亚组感兴趣，这些亚组从现有治疗中获得的改善最小。该K23奖项将为Juarascio博士提供必要的支持，以实现以下目标：（1）发展现有饮食病理学金标准治疗机制和治疗反应调节剂的专业知识，（2）获得设计，实施和评估门诊临床试验所需的技能和知识，（3）获得饮食病理学中假设维持因素的评估技术经验，重点是生物行为评估程序，（4）熟练掌握与临床试验研究相关的多层次和纵向分析方法，以及（5）提高与稿件准备、基金撰写和管理、临床监督和学术领导相关的技能。为了实现这些目标，Juarascio博士组建了一个由两名共同主要导师（Michael Lowe博士和Evan Forman博士），两名共同导师（Carl Lejuez博士和Matthew Hayes博士）和两名顾问（卡洛斯Grilo博士和Robert Gallop博士）组成的指导团队，她与他们一起制定了一项培训计划，该计划将为她提供成为一名成功的联邦资助独立调查员所需的技能。作为该培训计划的一部分，Juarascio博士将开发和评估一种新的治疗方法（营养咨询和基于接受的治疗，N-CAAT），用于体重抑制高的神经性贪食症（BN）患者，这是一个与BN症状的发展和维持相关的因素，治疗效果较差。这一亚组的不良结果可能是由于一旦恢复正常饮食行为就会发生可预测的体重增加。虽然体重增加可以减少促进持续病理学的生物行为约束，但体重增加也可能令人痛苦，并促进持续参与适应不良的饮食行为。需要解决核心维持因素的创新治疗来改善结果。拟议的项目将包括三个阶段，第一阶段侧重于创建治疗手册，第二阶段在小样本中对手册进行试点测试并评估目标参与度，第三阶段在小型试点RCT中测试N-CAAT的可行性，可接受性，目标参与度和目标验证。主要研究目的是评价招募、随机化、保留、评估程序和实施新治疗的可行性，以提高后续RCT的成功概率。这项研究将构成一项随机干预性试验的基础，该试验将在K23奖结束前提交R 01资助申请。

 DESCRIPTION (provided by applicant): The current project is a re-submission for a K23 award for Dr. Adrienne Juarascio, an Assistant Research Professor at Drexel University. Dr. Juarascio is establishing herself as an early-career investigator in patient oriented research with a focus on innovative treatment development for eating disorders. In particular, Dr. Juarascio is interested in using experimental therapeutics approaches to improve existing treatments for subgroups who experience minimal improvement from existing treatments. This K23 award will provide Dr. Juarascio with the necessary support to accomplish the following goals: (1) Develop expertise in the mechanisms of existing gold-standard treatments for eating pathology and moderators of response to treatment, (2) attain the skills and knowledge necessary to design, conduct, and evaluate clinical trials in outpatient settings, (3) gain experience with assessment techniques for hypothesized maintenance factors in eating pathology, with a focus on bio-behavioral assessment procedures, (4) build proficiency with multi-level and longitudinal analytic approaches related to clinical trial research, and (5) increase skills related to manuscript preparation, grant writing and management, clinical supervision, and academic leadership. To achieve these goals, Dr. Juarascio has assembled a mentoring team comprised of two co-primary mentors (Dr. Michael Lowe and Dr. Evan Forman), two co-mentors (Dr. Carl Lejuez, and Dr. Matthew Hayes) and two consultants (Dr. Carlos Grilo and Dr. Robert Gallop) with whom she has created a training plan that will provide her with the skills needed to become a successful federally-funded independent investigator. As part of this training plan, Dr. Juarascio will develop and assess a novel treatment (Nutritional Counseling and Acceptance-based Treatment, N-CAAT) for patients with bulimia nervosa (BN) who are high in weight suppression, a factor associated with the development and maintenance of BN symptoms and with poor treatment outcome. The poor outcomes for this sub-group are likely due to the predictable weight gain that occurs once normal eating behavior resumes. Although weight gain can reduce the biobehavioral bind that promotes continued pathology, weight gain can also be distressing and promote continued engagement in maladaptive eating behaviors. Innovative treatments that address core maintenance factors are needed to improve outcome. The proposed project will consist of three phases, with Phase I focusing on the creation of a treatment manual, Phase II pilot testing the manual in a small sample and assessing target engagement, and Phase III testing the feasibility, acceptability, target engagement, and target validation of N-CAAT in a small pilot RCT. The primary study aims will be to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, and implementation of the novel treatment to enhance the probability of success in subsequent RCTs. This research will form the basis of a randomized interventional trial that will be submitted in an R01 grant application before the end of the K23 award.