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Randomized Controlled Trial
. 2024 Nov;26(7):696-707.
doi: 10.1111/bdi.13489. Epub 2024 Sep 4.

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

Jennifer B Levin  1   2   3 , Melissa DelBello  4 , Avani C Modi  5 , Farren Briggs  6 , Larry F Forthun  7 , Molly McVoy  1   2   3 , Joy Yala  2 , Raechel Cooley  4 , Jessica Black  2 , Carla Conroy  1   2 , Martha Sajatovic  1   2   3   8
Affiliations
Randomized Controlled Trial

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

Jennifer B Levin et al. Bipolar Disord. 2024 Nov.

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.

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Conflict of interest statement

Jennifer B. Levin: Research grants within the past 3 years: Merck, National Institutes of Health (NIH), American Heart Association (AHA).

Melissa DelBello: Receives research support from NIH, PCORI, Alkermes, AbbVie, Intra-Cellular, Janssen, Johnson and Johnson, Lundbeck, Sage, Shire, Sunovion, and Vanda. She has also served as a consultant or on the advisory board for Alkermes, Janssen, Johnson and Johnson, Lundbeck, Myriad, and Sage.

Avani Modi:

Avani Modi: Research grants within the past 3 years include NIH, PCORI, and CCHMC Innovation Fund.

Farren Briggs: Speaker fees from Sanofi.

Larry Forthun: Research grants within the past 3 years include USDA National Institute of Food and Agriculture (NIFA) and Substance Abuse and Mental Health Services Administration (SAMHSA).

Molly McVoy: Research grants within past 3 years: The Hartwell Foundation, National Institutes of Health (NIH), Royalties in the past year: American Psychiatric Publishing, Compensation for preparation of/participation in CME activities past year: American Physician’s Institute (CMEtoGo).

Joy Yala: No conflicts of interest to report.

Raechel Cooley: No conflicts of interest to report.

Jessica Black: No conflicts of interest to report.

Carla Conroy: No conflicts of interest to report.

Martha Sajatovic: Research grants within past 3 years: Intra-Cellular, Merck, Otsuka, Alkermes, International Society for Bipolar Disorders (ISBD), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Patient-Centered Outcomes Research Institute (PCORI). Consultant in the past year: Alkermes, Otsuka, Janssen, Lundbeck, Teva, Neurelis. Royalties in the past year: Springer Press, Johns Hopkins University Press, Oxford Press, UpToDate. Compensation for preparation of/participation in CME activities past year: American Physician’s Institute (CMEtoGo), Psychopharmacology Institute, American Epilepsy Society, Clinical Care Options, American Academy of Child and Adolescent Psychiatry, Neurocrine

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References

    1. Di Salvo G, Porceddu G, Albert U, Maina G, Rosso G. Correlates of long duration of untreated illness (DUI) in patients with bipolar disorder: results of an observational study. Annals of general psychiatry. Mar 23 2023;22(1):12. doi:10.1186/s12991-023-00442-5 - DOI - PMC - PubMed
    1. Baldessarini RJ, Tondo L, Vazquez GH, et al. Age at onset versus family history and clinical outcomes in 1,665 international bipolar-I disorder patients. World Psychiatry. Feb 2012;11(1):40–6. doi:10.1016/j.wpsyc.2012.01.006 - DOI - PMC - PubMed
    1. Lublóy Á, Keresztúri JL, Németh A, Mihalicza P. Exploring factors of diagnostic delay for patients with bipolar disorder: a population-based cohort study. BMC psychiatry. Feb 19 2020;20(1):75. doi:10.1186/s12888-020-2483-y - DOI - PMC - PubMed
    1. Keramatian K, Pinto JV, Schaffer A, et al. Clinical and demographic factors associated with delayed diagnosis of bipolar disorder: Data from Health Outcomes and Patient Evaluations in Bipolar Disorder (HOPE-BD) study. J Affect Disord. Jan 01 2022;296:506–513. doi:10.1016/j.jad.2021.09.094 - DOI - PubMed
    1. Birmaher B, Axelson D, Strober M, et al. Clinical course of children and adolescents with bipolar spectrum disorders. Arch Gen Psychiatry. Feb 2006;63(2):175–83. doi:10.1001/archpsyc.63.2.175 - DOI - PMC - PubMed

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