Kristin A. Cassidy

Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic.

BACKGROUND Subjective experience of illness is a critical component of treatment adherence in populations with bipolar disorder (BPD). This cross-sectional analysis examined clinical and subjective variables in relation to adherence in 140 individuals with BPD receiving treatment with mood-stabilizing medication. METHODS Nonadherence was defined as missing 30% or more of medication on the Tablets Routine Questionnaire, a self-reported measure of medication treatment adherence. Adherent and nonadherent groups were compared on measures of attitudes toward illness and treatment including the Attitudes toward Mood Stabilizers Questionnaire, the Insight and Treatment Attitudes Questionnaire, the Rating of Medication Influences, and the Multidimensional Health Locus of Control Scale. RESULTS Except for substance abuse comorbidity, adherent individuals (n = 113, 80.7%) did not differ from nonadherent individuals (n = 27, 19.3%) on clinical variables. However, nonadherent individuals had reduced insight into illness, more negative attitudes toward medications, fewer reasons for adherence, and more perceived reasons for nonadherence compared with adherent individuals. The strongest attitudinal predictors for nonadherence were difficulties with medication routines (odds ratio = 2.2) and negative attitudes toward drugs in general (odds ratio = 2.3). LIMITATIONS Results interpretation is limited by cross-sectional design, self-report methodology, and sample size. CONCLUSIONS Comorbid substance abuse, negative attitudes toward mood-stabilizing medication, and difficulty managing to take medication in the context of ones daily schedule are primary determinants of medication treatment adherence. A patient-centered collaborative model of care that addresses negative attitudes toward medication and difficulty coping with medication routines may be ideally suited to address individual adherence challenges.

Illness experience and reasons for nonadherence among individuals with bipolar disorder who are poorly adherent with medication

AIM Nonadherent individuals are the most likely to avoid participating in research studies, thus limiting potential opportunities to develop evidence-based approaches for adherence enhancement. This mixed-method analysis evaluated factors related to adherence among 20 poorly adherent community mental health clinic patients with bipolar disorder (BD). METHODS Illness experience was evaluated with qualitative interview. Quantitative assessments measured symptoms (Hamilton Depression Rating Scale, Young Mania Rating Scale, Brief Psychiatric Rating Scale), adherence behavior, and treatment attitudes. Poor adherence was defined as missing 30% or more of medication. RESULTS Minorities (80%), unmarried individuals (95%), and those with substance abuse (65%) predominated in this nonadherent group of patients with BD. Individuals were substantially depressed (mean Hamilton Depression Rating Scale, 19.2), had at least some manic symptoms (mean Young Mania Rating Scale, 13.6), and had moderate psychopathology (mean Brief Psychiatric Rating Scale, 41.2). Rates of missed medications were 41% to 43%. Forgetting to take medications was the top reason for nonadherence (55%), followed by side effects (20%). Disorganized home environments (30%), concern regarding having to take long-term medications (25%) or fear of side effects (25%), and insufficient information regarding BD (35%) were relatively common. Almost one third of patients had individuals in their core social network who specifically advised against medication. Access problems included difficulty paying for medications among more than half of patients. Interestingly, patients reported good relationships with their providers. CONCLUSIONS Forgetting to take medication and problems with side effects are primary drivers of nonadherence. Lack of medication routines, unsupportive social networks, insufficient illness knowledge, and treatment access problems may likewise affect overall adherence. Complementary quantitative and qualitative data collection can identify reasons for nonadherence and may inform specific clinical approaches to enhance adherence.

A Comparison of the Life Goals Program and Treatment as Usual for Individuals With Bipolar Disorder

OBJECTIVE This randomized controlled study of 164 outpatients with bipolar disorder in a community mental health center who received standardized psychoeducation (Life Goals Program [LGP]) or treatment as usual sought to determine whether there were differences between the groups in medication adherence attitudes and behaviors. METHODS Patients were randomly assigned to treatment as usual (N=80) or treatment as usual plus LGP (N=84) and were assessed at baseline and at the three-, six-, and 12-month follow-up. Primary outcomes were change in score from baseline on the Drug Attitude Inventory (DAI) and on self-reported treatment adherence behaviors (SRTAB). RESULTS At baseline, there were no significant differences between the two groups. Slightly less than half (N=41, 49%) of the LGP group participated in most or all (four to six) LGP sessions, 14% (N=12) participated in one to three sessions, and 37% (N=31) did not participate in any sessions. At the 12-month follow-up there was improvement among all patients, with no significant differences between the two groups, in DAI scores, SRTAB, symptoms, psychopathology, and functional status. Greater depressive severity at baseline was associated with more negative attitudes toward treatment over time, although this finding was not significant (p=.056). Secondary analysis of persons in the LGP group found that compared with those who did not go to any LGP sessions, those with partial or full participation in LGP sessions had improved attitudes toward medication at the three- and six-month follow-up, but no difference was found between the three LGP subgroups by the 12-month follow-up. CONCLUSIONS There were no differences between two groups in treatment attitudes at the 12-month follow-up. Low attendance rates mitigated effects on primary outcomes. Effects of LGP may become lost over time without ongoing intervention, and individuals with depression may have reduced response to LGP.

Multisite, open-label, prospective trial of lamotrigine for geriatric bipolar depression: a preliminary report

Sajatovic M, Gildengers A, Al Jurdi RK, Gyulai L, Cassidy KA, Greenberg RL, Bruce ML, Mulsant BH, Ten Have T, Young RC. Multisite, open‐label, prospective trial of lamotrigine for geriatric bipolar depression: a preliminary report.
Bipolar Disord 2011: 13: 294–302.

Gender differences in subjective experience and treatment of bipolar disorder.

Treatment nonadherence is a leading cause of poor outcomes among populations with bipolar disorder (BD) and is related to subjective experience of illness and treatment. This study examined gender differences in the experience of illness and treatment for those with BD, specifically in regards to treatment adherence. This cross-sectional analysis pooled data from 3 BD studies. A semistructured qualitative instrument, the Subjective Experience of Medication Interview, elicited information on subjective differences in treatment adherence between men and women. Men and women experience comparable levels of stigma and they comparably value lessened irritability and/or impulsivity because of medications. However, men and women differed in fear of weight gain because of medications, value of social support, and self-medication behaviors. Selected differences in subjective illness experience between men and women might be used to inform gender-sensitive approaches to enhance treatment adherence among populations with BD.

Six-month outcomes of customized adherence enhancement (CAE) therapy in bipolar disorder

BACKGROUND There are few psychosocial interventions specifically focused on improved treatment adherence in people with bipolar disorder (BD). Customized adherence enhancement (CAE) is a needs-based, manualized approach intended to improve medication adherence in individuals with BD. This was a six-month prospective trial of a CAE among 43 medication non-adherent individuals with BD who were receiving treatment in a community mental health clinic (CMHC). METHODS CAE was flexibly administered in modules applied as indicated by an initial adherence vulnerabilities screening. Screening identified reasons for non-adherence and modules were then administered using pre-set criteria. CAE effects were evaluated at six-week, three-month, and six-month follow-up. The six-month follow-up was our primary time point of interest. The primary outcome was change from baseline in adherence using the Tablets Routine Questionnaire (TRQ) and pill counts. Secondary outcomes included change from baseline in BD symptoms [Hamilton Depression Rating Scale (HAM-D), Young Mania Rating Scale (YMRS), and Brief Psychiatric Rating Scale (BPRS)]. RESULTS Subjects completed 86% of scheduled sessions, with only two individuals (5%) not participating in any sessions. The number of dropouts at six months was 12 (28%). Mean baseline non-adherence by TRQ was 48% [standard error (SE) 4.8%] missed tablets within the previous week and 51% (4.1%) missed tablets within the previous month. At six-month follow-up, mean TRQ non-adherence improved to 25% (6.8%) missed tablets for the previous week (p = 0.002) and 21% (5.5%) for the previous month (p < 0.001). Symptoms improved, with a change in the baseline mean (SE) BPRS of 43.6 (1.8) versus an endpoint of 36.1 (2.3) (p = 0.001), and baseline mean (SE) HAM-D of 17.8 (1.1) versus an endpoint of 15.3 (1.6) (p = 0.044). CONCLUSION CAE was associated with improvements in adherence, symptoms, and functional status. Controlled trials are needed to confirm these preliminary findings.

Asenapine in the treatment of older adults with bipolar disorder

In spite of growing numbers of older people, there are few treatment studies on late‐life bipolar disorder (BD). This was a 12‐week prospective, open‐label trial to assess efficacy and tolerability of adjunct asenapine in non‐demented older adults (≥60 years) with sub‐optimal previous response to BD treatments.

Prospective Trial of Customized Adherence Enhancement Plus Long-Acting Injectable Antipsychotic Medication in Homeless or Recently Homeless Individuals With Schizophrenia or Schizoaffective Disorder

BACKGROUND Treatment nonadherence in people with schizophrenia is associated with relapse and homelessness. Building on the usefulness of long-acting medication and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with DSM-IV-defined schizophrenia or schizoaffective disorder. METHOD Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence, as measured by the Tablets Routine Questionnaire, and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. The study was conducted from July 2010 to December 2012. RESULTS The mean age of participants was 41.8 years (SD = 8.6); they were mainly minorities (90%, n = 27 African-American) and mainly single/never married (70%, n = 21). Most (97%, n = 29) had past or current substance abuse and had been incarcerated (97%, n = 29). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (at 6 months, 76%) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (P = .03). There were significant improvements in psychiatric symptoms (P < .001) and functioning (P < .001). Akathisia was a major side effect with LAI. CONCLUSIONS While interpretation of findings must be tempered by the methodological limitations, CAE-L appears to be associated with improved adherence, symptoms, and functioning in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01152697.

Customized adherence enhancement for individuals with bipolar disorder receiving antipsychotic therapy

OBJECTIVE A three-month prospective trial of a psychosocial intervention--customized adherence enhancement (CAE)--was conducted with 43 medication-nonadherent individuals with bipolar disorder. METHODS CAE modules were administered as indicated by a screen that identifies reasons for nonadherence. The primary outcome was change in adherence to mood-stabilizing medications as measured by the Tablet Routines Questionnaire and pill counts. Secondary outcomes included change in symptoms, measured by the Hamilton Rating Scale for Depression (HAM-D), Young Mania Rating Scale (YMRS), and Brief Psychiatric Rating Scale (BPRS). RESULTS Participants completed 76% of sessions. Dropout at three months was 13 (30%). Adherence improved from a baseline mean±SD of 34%±27% of tablets missed in the past month to only 10%±15% (p<.001). BPRS, HAM-D, andYMRS scores all indicated significant improvement at three-month follow-up (p<.05). CONCLUSIONS Although conclusions must be tempered by the uncontrolled design, CAE appeared to be well accepted and was associated with improvements in adherence, symptoms, and functioning.

Use of automated medication adherence monitoring in bipolar disorder research: pitfalls, pragmatics, and possibilities

Objectives: Medication nonadherence occurs in 20–60% of persons with bipolar disorder (BD) and is associated with serious negative outcomes, including relapse, hospitalization, incarceration, suicide and high healthcare costs. Various strategies have been developed to measure adherence in BD. This descriptive paper summarizes challenges and workable strategies using electronic medication monitoring in a randomized clinical trial (RCT) in patients with BD. Methods: Descriptive data from 57 nonadherent individuals with BD enrolled in a prospective RCT evaluating a novel customized adherence intervention versus control were analyzed. Analyses focused on whole group data and did not assess intervention effects. Adherence was assessed with the self-reported Tablets Routine Questionnaire and the Medication Event Monitoring System (MEMS). Results: The majority of participants were women (74%), African American (69%), with type I BD (77%). Practical limitations of MEMS included misuse in conjunction with pill minders, polypharmacy, cost, failure to bring to research visits, losing the device, and the device impacting baseline measurement. The advantages were more precise measurement, less biased recall, and collecting data from past time periods for missed interim visits. Conclusions: Automated devices such as MEMS can assist investigators in evaluating adherence in patients with BD. Knowing the anticipated pitfalls allows study teams to implement preemptive procedures for successful implementation in BD adherence studies and can help pave the way for future refinements as automated adherence assessment technologies become more sophisticated and readily available.