Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Bipolar Disord. 2024 Nov;26(7):696-707. doi: 10.1111/bdi.13489. Epub 2024 Sep 4.
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).
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).
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.
CAE-AYA may improve adherence in AYAs with BD, although conclusions need to be made cautiously given study limitations.
ClinicalTrials.gov identifier: NCT04348604.
很少有研究探讨双相情感障碍（BD）青少年和年轻人（AYA）的药物依从性。本 6 个月前瞻性随机对照试验（RCT）测试了针对 AYA 的定制药物依从性增强（CAE-AYA），这是一种针对 AYA 的行为干预，与增强的常规治疗（ETAU）相比。
纳入标准为年龄在 13-21 岁的 AYA，BD 为 I 型或 II 型，药物依从性定义为错过药物≥20%。评估在筛选、基线和第 8、12 和 24 周进行。主要结局是过去 7 天的自我报告的片剂常规问卷（TRQ），通过电子药盒监测（SimpleMed）进行验证。症状测量包括汉密尔顿抑郁评定量表（HAM-D）和 Young 躁狂评定量表（YMRS）。
平均样本年龄（N=36）为 19.1 岁（SD=2.0）；66.7%（N=24）为女性，BD 类型 I（81%）。总样本在 TRQ 上错过的药物平均值为筛选时的 35.4%（SD=28.8）和基线时的 30.4%（SD=30.5）。CAE-AYA 和 ETAU 均从筛选到基线提高了 TRQ。使用 SimpleMed 的基线平均漏药率为 51.6%（SD=38.5）。基线 HAM-D 和 YMRS 平均值分别为 7.1（SD=4.7）和 6.0（SD=7.3）。第 24 周的失访率为 36%。调整年龄、性别、教育水平、生活状况、家族史、种族和民族后，TRQ 从基线到 24 周的变化显示，CAE-AYA 优于 ETAU 的改善为 15%。由于数据缺失严重，SimpleMed 的解释受到限制。CAE-AYA 显著降低了抑郁症状。
CAE-AYA 可能会改善 BD 青少年和年轻人的药物依从性，尽管考虑到研究的局限性，需要谨慎得出结论。
ClinicalTrials.gov 标识符：NCT04348604。
