一项针对依从性不佳的青少年和年轻成人双相障碍患者的定制依从性增强计划：试验设计和方法学报告。
A customized adherence enhancement program for adolescents and young adults with suboptimal adherence and bipolar disorder: Trial design and methodological report.
机构信息
Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, OH, United States of America; Case Western Reserve University School of Medicine, Cleveland, OH, United States of America; Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, United States of America.
University of Cincinnati, College of Medicine, Cincinnati, OH, United States of America.
出版信息
Contemp Clin Trials. 2022 Apr;115:106729. doi: 10.1016/j.cct.2022.106729. Epub 2022 Mar 9.
BACKGROUND
The onset of bipolar disorder (BD) is common during late adolescence and young adulthood (AYA). Suboptimal medication adherence is a critical yet modifiable risk factor for negative outcomes among AYAs with BD.
METHODS
This research used an iterative process (e.g., focus groups, advisory board, cognitive interviews) to modify an existing adherence intervention to address suboptimal adherence in AYAs with BD. The modified version of Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA) will be compared to an Enhanced Treatment as Usual condition (ETAU) in 40 AYAs intervention using a 6-month prospective, randomized controlled trial (RCT) in a high-risk group of 16-21 year old AYAs with BD with demonstrated non-adherence to their prescribed BD medications.
CONCLUSIONS
This report describes the methodology and design of the ImprovinG adhereNce In adolescenTs with bipolar disordEr (IGNITE) study. If successful, the CAE-AYA approach has the potential to advance care for vulnerable youth with BD.
背景
双相情感障碍（BD）的发病常见于青少年晚期和青年期（AYA）。药物治疗依从性差是 AYA 双相情感障碍患者出现不良结局的一个关键但可改变的危险因素。
方法
本研究采用迭代过程（例如焦点小组、顾问委员会、认知访谈）来修改现有的依从性干预措施，以解决 AYA 双相情感障碍患者的依从性差问题。经过修改的青少年和青年期定制依从性增强（CAE-AYA）版本将与增强的常规治疗（ETAU）进行比较，研究对象为 40 名 AYA，采用 6 个月前瞻性随机对照试验（RCT），在一个高危人群中，即 16-21 岁的 AYA 双相情感障碍患者，他们对规定的双相情感障碍药物治疗不依从。
结论
本报告介绍了 ImprovinG adhereNce In adolescenTs with bipolar disordEr（IGNITE）研究的方法和设计。如果成功，CAE-AYA 方法有可能为患有双相情感障碍的脆弱青年提供更好的护理。
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