Addressing Weight History to Improve Behavioral Treatments for Bulimia Nervosa

 描述(由申请者提供)：目前的项目是为德雷克塞尔大学助理研究教授Adrienne Juarascio博士重新提交的K23奖项。Juarascio博士在以患者为导向的研究中确立了自己作为职业生涯早期研究员的地位 专注于饮食失调的创新治疗开发。尤其是，Juarascio博士对使用实验治疗方法来改进现有治疗方法感兴趣，这些治疗方法适用于那些从现有治疗中获得最小改善的亚组。这一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黄金标准治疗机制和治疗反应调节剂的专业知识，(2)获得在门诊环境下设计、进行和评估临床试验所需的技能和知识，(3)获得关于饮食病理学假想维持因素评估技术的经验，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)提高与手稿准备、拨款撰写和管理、临床监督、和学术领导力。为了实现这些目标，Juarascio博士组建了一个指导团队，成员包括两名联合初选导师(Michael Lowe博士和Evan Forman博士)、两名联合导师(Carl Lejuez博士和Matthew Hayes博士)和两名顾问(Carlos Grilo博士和Robert Gallop博士)，她与他们共同制定了培训计划，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。作为这项培训计划的一部分，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)，用于治疗体重抑制程度高的神经性暴食症(BN)患者，这是与BN症状的发展和维持以及治疗结果较差相关的一个因素。这一群体的不良结果可能是因为一旦恢复正常的饮食行为，体重就会增加，这是可以预见的。虽然体重增加可以减少促进持续病理的生物行为束缚，但体重增加也可能令人痛苦，并促进持续参与不适应的饮食行为。需要针对核心维持因素的创新治疗方法来改善结果。拟议的项目将包括三个阶段，第一阶段侧重于编制治疗手册，第二阶段在小样本中测试手册并评估目标参与，第三阶段在小规模试点随机对照试验中测试N-CAAT的可行性、可接受性、目标参与和目标确认。该研究的主要目的将是评估招募、随机化、保留、评估程序和实施新的治疗方法的可行性，以提高后续随机对照试验的成功率。这项研究将形成一项随机干预试验的基础，该试验将在K23奖结束前提交R01拨款申请。

 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.