Improving Adherence in Adolescents and Young Adultswith Bipolar Disorder

项目总结 双相情感障碍(BD)最常见的发病时期是在青春期晚期和成年期早期。而当 药物治疗对青少年和青壮年的BD症状有效，依从性差 在超过65%的AYA中，与低恢复率、高复发率和5.2倍 自杀风险增加。依从性差是AYAS合并BD预后不良的一个关键但可改变的危险因素。 鉴于增强版的潜在影响，AYA是针对和测试依从性干预措施的理想BD子组 在这一关键的发展时期坚持社会、教育和职业目标 终身BD自我管理技能的基础。到目前为止，还没有专门针对 AYAS合并BD患者的依从性。 这份R34提案是对RFA-MH-18-706，治疗的试点有效性试验的回应而写的， 预防和服务干预将修改和测试具有BD的AYA，有效的定制遵守 研究小组为成年BD患者制定了增强(CAE)干预措施。CAE是一种简短、实用的 依从性促进干预，可高度概括到现实世界的临床环境。在成人中，CAE 与严格的特定于BD的教育控制相比，显著提高遵从性。调查组 总部设在两个学术医疗中心(凯斯西储大学/CWRU和华盛顿大学 辛辛那提/加州大学)由两家由NIH资助的优势互补的私人投资机构领导。 拟议的三阶段项目将确定AYA的相关特征和CAE所需的改进 (阶段1)并使用基于患者反馈的迭代改进来标准化干预(阶段2)。 第一和第二阶段将在12个月的时间内完成。在第三阶段(13-36个月)，我们将测试 采用随机对照试验(RCT)的适应方法的可行性、可接受性和初步疗效 针对高风险、高需求人群的设计：16-21岁患有BD的Ayas，他们对处方BD的依从性很差 药物。总的假设是，对于依从性差的AYA与BD(CAE-AYA)的CAE将相关 与常规强化治疗(Etau)相比，6个月随访时依从性得到改善。初级阶段 结果将与平板电脑常规问卷(TRQ)中的基线和电子依从性发生变化 监控(SimpleMed盒子)。二次结果将评估精神症状和健康的变化- 相关的生活质量。其他分析将检验BD AYA中黏附改变的可能机制 因为它涉及到双相知识不足、与临床医生沟通不畅以及 家庭、不稳定的用药习惯和药物使用/危险行为。如果被证明有效，拟议的试验将 为CAE-Aya的严格疗效试验铺平道路。

PROJECT SUMMARY The most common onset of bipolar disorder (BD) is during late adolescence and early adulthood. While pharmacotherapy is effective for BD symptoms in adolescents and young adults (AYA), poor adherence occurs in more than 65% of AYAs and is associated with low rates of recovery, high rates of relapse and a 5.2 fold increase in suicide risk. Poor adherence is a critical yet modifiable risk factor of poor outcomes in AYAs with BD. AYAs are an ideal BD subgroup to target and test adherence interventions given the potential impact of enhanced adherence on social, educational and occupational goals during this critical developmental period which can lay the foundation for lifelong BD self-management skills. To date, there are no interventions that specifically target adherence in AYAs with BD. This R34 proposal, written in response to RFA-MH-18-706, Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions will modify and test in AYAs with BD, an effective customized adherence enhancement (CAE) intervention developed for adults with BD by the investigative team. CAE is a brief, practical adherence promotion intervention that is highly generalizable to real-word clinical settings. In adults, CAE improves adherence significantly more than a rigorous BD-specific educational control. The investigative team is based in two academic medical centers (Case Western Reserve University/CWRU and University of Cincinnati/UC) led by two NIH-funded PIs with complementary strengths. The proposed 3-phase project will identify relevant characteristics of AYAs and needed refinements to CAE (Phase 1) and standardize the intervention using iterative refinements based on patient feedback (Phase 2). Phases 1 and 2 will be completed over a 12-month time-period. In Phase 3 (months 13-36) we will test the feasibility, acceptability and preliminary efficacy of the adapted approach using a randomized controlled trial (RCT) design in a high-risk, high-need group: AYAs ages 16-21 with BD who are poorly adherent with prescribed BD medications. The overall hypothesis is that CAE for poorly adherent AYAs with BD (CAE-AYA) will be associated with improved adherence at 6-month follow-up compared to enhanced treatment as usual (ETAU). The primary outcome will be change from baseline in the Tablets Routine Questionnaire (TRQ) and electronic adherence monitoring (SimpleMed boxes). Secondary outcomes will evaluate change in psychiatric symptoms and health- related quality of life. Additional analysis will examine the posited mechanisms of adherence change in BD AYAs as it relates to the adherence barriers of inadequate bipolar knowledge, poor communication with clinicians and family, unstable medication routines and substance use/risky behaviors. If proven effective, the proposed trial will pave the way for a rigorous efficacy trial of CAE-AYA.