A 6-month, prospective, randomized controlled trial of customized adherence enhancement versus a bipolar-specific educational control in poorly adherent adolescents and young adults living with bipolar disorder.

IF 5 2区医学 Q1 CLINICAL NEUROLOGY

Bipolar Disorders Pub Date : 2024-09-04 DOI:10.1111/bdi.13489

Jennifer B Levin, Melissa DelBello, Avani C Modi, Farren Briggs, Larry F Forthun, Molly McVoy, Joy Yala, Raechel Cooley, Jessica Black, Carla Conroy, Martha Sajatovic

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Abstract

Objective: Few studies have addressed medication adherence in adolescents and young adults (AYAs) with bipolar disorder (BD). This 6-month prospective randomized-controlled trial (RCT) tested customized adherence enhancement for adolescents and young adults (CAE-AYA), a behavioral intervention for AYAs versus enhanced treatment as usual (ETAU).

Methods: Inclusion criteria were AYAs age 13-21 with BD type I or II with suboptimal adherence defined as missing ≥20% of medications. Assessments were conducted at Screening, Baseline, and weeks 8, 12 and 24. Primary outcome was past 7 day self-reported Tablets Routine Questionnaire (TRQ) validated by electronic pillbox monitoring (SimpleMed). Symptom measures included the Hamilton Depression Rating Scale (HAM-D) and Young Mania Rating Scale (YMRS).

Results: The mean sample age (N = 36) was 19.1 years (SD = 2.0); 66.7% (N = 24) female, BD Type I (81%). The mean missed medication on TRQ for the total sample was 35.4% (SD = 28.8) at screening and 30.4% (SD = 30.5) at baseline. Both CAE-AYA and ETAU improved on TRQ from screening to baseline. Baseline mean missed medication using SimpleMed was 51.6% (SD = 38.5). Baseline HAM-D and YMRS means were 7.1 (SD = 4.7) and 6.0 (SD = 7.3), respectively. Attrition rate at week 24 was 36%. Baseline to 24-week change on TRQ, adjusting for age, gender, educational level, living situation, family history, race, and ethnicity, showed improvement favoring CAE-AYA versus ETAU of 15%. SimpleMed interpretation was limited due to substantial missing data. There was a significant reduction in depression favoring CAE-AYA.

Conclusions: CAE-AYA may improve adherence in AYAs with BD, although conclusions need to be made cautiously given study limitations.

Clinical trials registration: ClinicalTrials.gov identifier: NCT04348604.

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一项为期 6 个月的前瞻性随机对照试验，针对罹患双相情感障碍、依从性较差的青少年和年轻成年人，进行了定制依从性强化与双相情感障碍专用教育对照的对比试验。

目的：针对患有双相情感障碍（BD）的青少年的服药依从性研究很少。这项为期 6 个月的前瞻性随机对照试验（RCT）测试了为青少年量身定制的依从性强化疗法（CAE-AYA），这是一项针对青少年的行为干预措施，与常规强化治疗（ETAU）进行了对比：纳入标准为13-21岁患有I型或II型BD的青少年，其依从性不佳的定义为漏服药物≥20%。在筛查、基线、第 8、12 和 24 周进行评估。主要结果是通过电子药盒监测（SimpleMed）验证的过去 7 天自我报告片剂常规问卷（TRQ）。症状测量包括汉密尔顿抑郁评定量表（HAM-D）和青年躁狂评定量表（YMRS）：样本平均年龄（N = 36）为 19.1 岁（SD = 2.0）；66.7%（N = 24）为女性，BD I 型（81%）。筛查时，总样本的 TRQ 平均漏服药率为 35.4%（SD = 28.8），基线时为 30.4%（SD = 30.5）。从筛查到基线，CAE-AYA 和 ETAU 的 TRQ 均有所改善。使用 SimpleMed 的基线平均漏服药率为 51.6%（SD = 38.5）。基线 HAM-D 和 YMRS 平均值分别为 7.1（标准差 = 4.7）和 6.0（标准差 = 7.3）。第24周的流失率为36%。根据年龄、性别、教育程度、生活状况、家族史、种族和民族等因素进行调整后，TRQ从基线到第24周的变化显示，CAE-AYA比ETAU改善了15%。由于大量数据缺失，简单医学解释受到限制。结论：CAE-AYA可明显减少抑郁症的发生：CAE-AYA可能会改善患有BD的AYAs的依从性，但鉴于研究的局限性，需要谨慎做出结论：临床试验注册：ClinicalTrials.gov identifier：NCT04348604。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bipolar Disorders 医学-精神病学

CiteScore

8.20

自引率

7.40%

发文量

审稿时长

6-12 weeks

期刊介绍： Bipolar Disorders is an international journal that publishes all research of relevance for the basic mechanisms, clinical aspects, or treatment of bipolar disorders and related illnesses. It intends to provide a single international outlet for new research in this area and covers research in the following areas: biochemistry physiology neuropsychopharmacology neuroanatomy neuropathology genetics brain imaging epidemiology phenomenology clinical aspects and therapeutics of bipolar disorders Bipolar Disorders also contains papers that form the development of new therapeutic strategies for these disorders as well as papers on the topics of schizoaffective disorders, and depressive disorders as these can be cyclic disorders with areas of overlap with bipolar disorders. The journal will consider for publication submissions within the domain of: Perspectives, Research Articles, Correspondence, Clinical Corner, and Reflections. Within these there are a number of types of articles: invited editorials, debates, review articles, original articles, commentaries, letters to the editors, clinical conundrums, clinical curiosities, clinical care, and musings.