Patient choice as a driver of medication-switching in non-adherent individuals with bipolar disorder.

OBJECTIVE: Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects satisfaction with treatment and may lead to non-adherence and relapse. This was a 12-week, uncontrolled prospective trial of patient-choice-facilitated ziprasidone switching among non-adherent BD patients with weight concerns. This study was conducted from January 2011 to July 2012. METHOD: Patients were asked to identify the "offending" BD medication which they believed was causing weight problems, and this agent was replaced with ziprasidone. The primary outcome was change in adherence as measured with the Tablets Routine Questionnaire (TRQ). Secondary outcomes included medication attitudes, BD symptoms, global psychopathology, social functioning, and quality of life. RESULTS: The most common agents causing weight concerns were quetiapine (N=7, 23%), aripiprazole (N=4, 13%), olanzapine, lithium, and divalproex (all N=3, 10%). Adherence improved from a baseline of missing 48.6% of prescribed BD medication in the past week (44.9% in the past month) to missing 25.3% (P=0.002) of prescribed BD medication in the past week (P<0.001, in the past month) at endpoint. Medication attitudes, symptoms, functioning, and quality of life improved but there were no differences in body weight. CONCLUSION: While findings must be tempered by methodological limitations such as small sample and uncontrolled design, patient-facilitated medication-switching appeared to improve adherence and BD outcomes in these non-adherent individuals. Additional studies involving patient-facilitated medication-switching and shared decision-making in BD are needed.

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.

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.

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.

Best practices: Optimizing care for people with serious mental illness and comorbid diabetes.

Diabetes and obesity among patients with serious mental illness are common. Use of second-generation antipsychotics compounds risk, and widely prevalent unhealthy behaviors further contribute to negative outcomes. This column describes Targeted Training in Illness Management, a group-based psychosocial treatment that blends psychoeducation, problem identification, goal setting, and behavioral modeling and reinforcement. The intervention has been adapted to the primary care setting and is targeted at individuals with serious mental illness and diabetes. A key feature of the intervention is the use of peer educators with serious mental illness and diabetes to teach and model self-management. Promising results from a 16-week trial are reported.