A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder

Abstract

Objective: Nonadherence in bipolar disorder (BD) ranges from 20% to 60%. Customized adherence enhancement (CAE) is a brief, BD-specific approach that targets individual adherence barriers. This prospective, 6-month, randomized controlled trial conducted from October 2012 to July 2017 compared CAE versus a rigorous BD-specific educational program (EDU) on adherence, symptoms, and functional outcomes in poorly adherent individuals.

Methods: One hundred eighty-four participants with DSM-IV BD were randomized to CAE (n = 92) or EDU (n = 92). Primary outcome was adherence change measured by the Tablets Routine Questionnaire (TRQ) and BD symptoms measured by the Brief Psychiatric Rating Scale. Other outcomes were scores on the Global Assessment of Functioning, Montgomery-Asberg Depression Rating Scale, Young Mania Rating Scale, and Clinical Global Impressions Scale. Assessments were conducted at screening, baseline, 10 weeks, 14 weeks, and 6 months.

Results: The sample mean (SD) age was 47.40 (10.46) years; 68.5% were female, and 63.0% were African American. At screening, individuals missed a mean (SD) of 55.15% (28.22%) of prescribed BD drugs within the past week and 48.01% (28.46%) in the past month. Study attrition was < 20%. At 6 months, individuals in CAE had significantly improved past-week (P = .001) and past-month (P = .048) TRQ scores versus those in EDU. Past-week TRQ score improvement remained significant after adjustment for multiple comparisons. There were no treatment arm differences in BPRS scores or other symptoms, possibly related to low symptom baseline values. Baseline-to-6-month comparison showed significantly higher GAF scores (P = .036) for CAE versus EDU. Although both groups used more mental health services at 6 months compared to baseline, increase for CAE was significantly less than that for EDU (P = .046).

Conclusions: Whereas both CAE and EDU were associated with improved outcomes, CAE had additional positive effects on adherence, functioning, and mental health resource use compared to EDU.

Trial registration: ClinicalTrials.gov identifier: NCT00183495.

Conflict of interest statement

Potential conflicts of interest: Dr. Sajatovic has research grants from Alkermes, Pfizer, Merck, Janssen, Reuter Foundation, Woodruff Foundation, Reinberger Foundation, National Institute of Health (NIH), and the Centers for Disease Control and Prevention (CDC). Dr. Sajatovic is a consultant to Bracket, Otsuka, Supernus, Neurocrine, Health Analytics and Sunovion and has received royalties from Springer Press, Johns Hopkins University Press, Oxford Press, and UpToDate. Dr. Ramirez has served as speaker for Bristol-Myers Squibb, Merck, Novartis, and Janssen in the past and currently serves as speaker for Otsuka and Sunovion. Dr. Ramirez also serves on advisory boards for Teva and Vanta. Dr. Tatsoka has research grants from the National Science Foundation, Biogen, and Philips Healthcare. Dr. Perzynski is co-founder of Global Health Metrics, LLC and has book contracts for royalties with Springer Press and Taylor Francis. Dr. Safren has research grants from the National Institutes of Health, and receives royalties from Oxford University Press, Guilford Publications, and Springer/Humana Press for authored books. Dr. Bauer has received royalties from New Harbinger Press and Springer Press

Dr. Levin, Ms. Cassidy, Mr. Klein, Ms. Fuentes-Casiano, Dr. Blixen, and Ms. Aebi declare no conflicts of interest.

© Copyright 2018 Physicians Postgraduate Press, Inc.

Figures

Figure 1:

CONSORT diagram of study flow aOne was withdrawn from the study by the PI immediately after randomization, prior to EDU intervention