1. 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.
- Author
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Levin JB, DelBello M, Modi AC, Briggs F, Forthun LF, McVoy M, Yala J, Cooley R, Black J, Conroy C, and Sajatovic M
- Subjects
- Humans, Female, Male, Adolescent, Young Adult, Psychiatric Status Rating Scales, Prospective Studies, Patient Education as Topic methods, Treatment Outcome, Bipolar Disorder drug therapy, Bipolar Disorder therapy, Medication Adherence
- 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., (© 2024 The Author(s). Bipolar Disorders published by John Wiley & Sons Ltd.)
- Published
- 2024
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