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

Abstract

AbstractObjectiveFew 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).MethodsInclusion 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).ResultsThe 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.ConclusionsCAE‐AYA may improve adherence in AYAs with BD, although conclusions need to be made cautiously given study limitations.Clinical Trials RegistrationClinicalTrials.gov identifier: NCT04348604.