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

Martha X Sajatovic, Curtis M Tatsuoka, Kristin A. Cassidy, Peter J. Klein, Edna Fuentes-Casiano, Jamie Cage, Michelle E. Aebi, Luis F. Ramirez, Carol Blixen, Adam Thomas Perzynski, Mark S. Bauer, Steven A. Safren, Jennifer Levin

Research output: Contribution to journalArticle

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.

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.

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).

LanguageEnglish (US)
JournalThe Journal of clinical psychiatry
Volume79
Issue number6
DOIs
StatePublished - Sep 25 2018

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Bipolar Disorder
Randomized Controlled Trials
Tablets
Brief Psychiatric Rating Scale
Health Resources
Mental Health Services
Diagnostic and Statistical Manual of Mental Disorders
African Americans
Mental Health
Depression
Pharmaceutical Preparations
Surveys and Questionnaires

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. / Sajatovic, Martha X; Tatsuoka, Curtis M; Cassidy, Kristin A.; Klein, Peter J.; Fuentes-Casiano, Edna; Cage, Jamie; Aebi, Michelle E.; Ramirez, Luis F.; Blixen, Carol; Perzynski, Adam Thomas; Bauer, Mark S.; Safren, Steven A.; Levin, Jennifer.

In: The Journal of clinical psychiatry, Vol. 79, No. 6, 25.09.2018.

Research output: Contribution to journalArticle

Sajatovic, Martha X ; Tatsuoka, Curtis M ; Cassidy, Kristin A. ; Klein, Peter J. ; Fuentes-Casiano, Edna ; Cage, Jamie ; Aebi, Michelle E. ; Ramirez, Luis F. ; Blixen, Carol ; Perzynski, Adam Thomas ; Bauer, Mark S. ; Safren, Steven A. ; Levin, Jennifer. / A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. In: The Journal of clinical psychiatry. 2018 ; Vol. 79, No. 6.
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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.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.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).",
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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 Thomas

AU - Bauer, Mark S.

AU - Safren, Steven A.

AU - Levin, Jennifer

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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.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.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).

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.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.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).

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