Author ORCID Identifier
Document Type
Article
Publication Date
9-4-2024
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.
Keywords
adherence, adolescents and young adults, bipolar disorder, mood stabilizer
Language
english
Publication Title
Bipolar Disorders
Grant
MH117206
Rights
© The Author(s) 2024. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/), which permits non-commercial copying and redistribution of the material in any medium or format, provided the original work is not changed in any way and is properly cited.
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.
Recommended Citation
Levin JB, DelBello M, Modi AC, et al.A 6-month, prospective, randomized controlled trial ofcustomized adherence enhancement versus a bipolar-specific educational control in poorly adherent adolescentsand young adults living with bipolar disorder. Bipolar Disord.2024;26:696-707. doi:10.1111/bdi.13489
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