TY - JOUR
T1 - A 6-month, prospective, randomized controlled trial of customized adherence enhancement versus bipolar-specific educational control in poorly adherent individuals with bipolar disorder
AU - Sajatovic, Martha
AU - Tatsuoka, Curtis
AU - Cassidy, Kristin A.
AU - Klein, Peter J.
AU - Fuentes-Casiano, Edna
AU - Cage, Jamie
AU - Aebi, Michelle E.
AU - Ramirez, Luis F.
AU - Blixen, Carol
AU - Perzynski, Adam T.
AU - Bauer, Mark S.
AU - Safren, Steven A.
AU - Levin, Jennifer B.
N1 - Funding Information:
Submitted: November 21, 2017; accepted March 30, 2018. Published online: September 25, 2018. Potential conflicts of interest: Dr Sajatovic has research grants from Alkermes, Pfizer, Merck, Janssen, Reuter Foundation, Woodruff Foundation, Reinberger Foundation, National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC); 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 and also serves on advisory boards for Teva and Vanta. Dr Tatsuoka 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 NIH 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. Drs Cage, Blixen, and Levin; Mss Cassidy, Fuentes-Casiano, and Aebi; and Mr Klein declare no conflicts of interest. Funding/support: This study was supported by National Institute of Mental Health (NIMH) grant 1R01MH093321-01A1 (PI: Dr Sajatovic) and by the Clinical and Translational Science Award (CTSC) UL1TR 00043 for REDCap.
Funding Information:
This study was supported by National Institute of Mental Health (NIMH) grant 1R01MH093321-01A1 (PI: Dr Sajatovic) and by the Clinical and Translational Science Award (CTSC) UL1TR 00043 for REDCap.
Publisher Copyright:
© Copyright 2018 Physicians Postgraduate Press, Inc.
PY - 2018/11/1
Y1 - 2018/11/1
N2 - 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.
AB - 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.
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U2 - 10.4088/JCP.17m12036
DO - 10.4088/JCP.17m12036
M3 - Article
C2 - 30256551
AN - SCOPUS:85054391774
VL - 79
JO - Journal of Clinical Psychiatry
JF - Journal of Clinical Psychiatry
SN - 0160-6689
IS - 6
ER -