Improving Adherence in Adolescents and Young Adultswith Bipolar Disorder

提高双相情感障碍青少年和年轻人的依从性

• 批准号: 10172981
• 负责人: Melissa P Delbello
• 金额: $ 24.72万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-08 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10172981
• 关键词: Academic Medical Centers; Address; Adherence; Adolescence; Adolescent; Adolescent Development; Adolescent and Young Adult; Adult; Age; Alcohol consumption; Behavior; Behavior Therapy; Bipolar Disorder; Caregivers; Characteristics; Clinical; Clinical Treatment; Communication; Conflict (Psychology); Custom; Data; Development; Evidence based intervention; Family; Feedback; Focus Groups; Foundations; Funding; Goals; Health; Health Personnel; Homelessness; Hospitalization; Imprisonment; Individual; Intervention; Knowledge; Measures; Mediating; Methodology; Monitor; Neurobiology; Occupational; Outcome; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Process; Provider; Questionnaires; Randomized Controlled Trials; Recovery; Relapse; Research Personnel; Risk Behaviors; Risk Factors; Risk-Taking; Self Management; Standardization; Statistical Data Interpretation; Subgroup; Supervision; Symptoms; Tablets; Testing; Time; United States National Institutes of Health; Universities; Vulnerable Populations; base; cognitive interview; critical developmental period; effectiveness trial; efficacy trial; emerging adult; empowered; experience; feasibility testing; follow-up; health related quality of life; high risk; high risk population; high-risk adolescents; improved; innovation; medication compliance; modifiable risk; mortality; patient oriented; prevent; preventive intervention; primary outcome; psychiatric symptom; psychoeducational; response; secondary outcome; service intervention; skills; social; substance use; suicidal risk; therapy design; treatment as usual; trial design

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.

项目摘要 躁郁症（BD）最常见的发作是在青春期和成年初期。尽管 药物治疗对青少年和年轻人的BD症状有效 在超过65％的AYA中，与恢复率低，复发率和5.2倍有关 自杀风险增加。依从性差是BD AYA中不良结果的关键但可改变的危险因素。 鉴于增强的潜在影响，AYA是目标和测试依从性干预措施的理想BD子组 在这个关键的发展时期，遵守社会，教育和职业目标 终身BD自我管理技能的基础。迄今为止，尚无专门针对的干预措施 在AYAS与BD的依从性。 这项R34提案是根据RFA-MH-18-706的响应，《治疗试验效率试验》编写的 预防和服务干预措施将通过BD进行修改和测试，这是有效的定制依从性 调查小组为成年人开发了增强（CAE）干预措施。 CAE是一个简短的实用 依从性促进干预措施高度可以推广到现实术的临床环境。在成人，凯西 不仅仅是严格的BD特异性教育控制，提高了依从性。调查团队 位于两个学术医疗中心（Case Western Reserve University/CWRU和University of University 辛辛那提/UC）由两个NIH资助的PI，具有互补的强度。 拟议的3阶段项目将确定AYA的相关特征，并为CAE确定所需的改进 （第1阶段）并根据患者反馈（第2阶段）使用迭代修补措施标准化干预措施。 第1阶段和第2阶段将在12个月的周期内完成。在第3阶段（13-36个月）中，我们将测试 使用随机对照试验（RCT）的适应方法的可行性，可接受性和初步疗效 在高风险，高需求的人群中的设计：AYAS 16-21岁的BD，他们对处方的BD依靠不佳 药物。总体假设是，与BD（CAE-AYA）相关的依从性AYA的CAE将与 与像往常一样增强的治疗（ETAU）相比，在6个月的随访中的依从性提高。主要 结果将是平板电脑常规问卷（TRQ）和电子依从性的基线变化 监视（简单框）。次要结果将评估精神症状和健康的变化 - 相关的生活质量。其他分析将检查BD AYAS依从性变化的提出机制 这与双相知识不足，与临床医生的沟通不足以及 家庭，不稳定的药物常规和药物使用/危险行为。如果证明有效，则拟议的审判将 为CAE-AYA进行严格的功效试验铺平了道路。