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OBJECTIVE: Individuals with bipolar disorder (BD) have high rates of suboptimal medication adherence, medical illness, and premature mortality, largely from cardiovascular causes. This analysis examined the association between adherence to antihypertensive and BD medications and clinical symptoms in patients with BD and comorbid hypertension (HTN) from an ongoing trial to optimize adherence. METHOD: Inclusion criteria were a BD diagnosis, treatment with antihypertensives, adherence challenges, and poorly controlled HTN. Adherence was measured via self-report using the Tablets Routine Questionnaire and using eCAP, an electronic pillcap which captures openings. Average systolic blood pressure (SBP) was calculated from 12 readings over 1 week. The Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Psychiatric Rating Scale (BPRS) assessed BD symptoms. RESULTS: A total of 83 participants with BD and HTN were included. Adherence to BD and antihypertensive medications were positively correlated. eCAP openings showed more missed doses than self-reported antihypertensive adherence. BD medication adherence was positively correlated with BPRS at baseline; antihypertensive adherence was negatively correlated with SBP at screening. Antihypertensive adherence improved and SBP decreased between screening and baseline. CONCLUSIONS: Adherence levels fluctuated over time and differed based on measurement method in people with comorbid BD and HTN. Self-reported BD adherence was positively related to global psychiatric symptoms and antihypertensive adherence was related to better SBP control. Monitoring both medication and blood pressure led to change in self-reported adherence. BD symptom severity may indicate poor adherence in patients with BD and should be considered in treatment planning.

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OBJECTIVE: Few studies have addressed medication adherence in adolescents and young adults (AYAs) with bipolar disorder (BD). This 6-month prospective randomized-controlled trial (RCT) tested customized adherence enhancement for adolescents and young adults (CAE-AYA), a behavioral intervention for AYAs versus enhanced treatment as usual (ETAU). METHODS: Inclusion criteria were AYAs age 13-21 with BD type I or II with suboptimal adherence defined as missing ≥20% of medications. Assessments were conducted at Screening, Baseline, and weeks 8, 12 and 24. Primary outcome was past 7 day self-reported Tablets Routine Questionnaire (TRQ) validated by electronic pillbox monitoring (SimpleMed). Symptom measures included the Hamilton Depression Rating Scale (HAM-D) and Young Mania Rating Scale (YMRS). RESULTS: The mean sample age (N = 36) was 19.1 years (SD = 2.0); 66.7% (N = 24) female, BD Type I (81%). The mean missed medication on TRQ for the total sample was 35.4% (SD = 28.8) at screening and 30.4% (SD = 30.5) at baseline. Both CAE-AYA and ETAU improved on TRQ from screening to baseline. Baseline mean missed medication using SimpleMed was 51.6% (SD = 38.5). Baseline HAM-D and YMRS means were 7.1 (SD = 4.7) and 6.0 (SD = 7.3), respectively. Attrition rate at week 24 was 36%. Baseline to 24-week change on TRQ, adjusting for age, gender, educational level, living situation, family history, race, and ethnicity, showed improvement favoring CAE-AYA versus ETAU of 15%. SimpleMed interpretation was limited due to substantial missing data. There was a significant reduction in depression favoring CAE-AYA. CONCLUSIONS: CAE-AYA may improve adherence in AYAs with BD, although conclusions need to be made cautiously given study limitations. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT04348604.

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Background: Given the importance of medication adherence among individuals with bipolar disorder (BD), this analysis from an ongoing randomized controlled trial (RCT) examined the relationship between BD symptoms, functioning and adherence in 69 poorly adherent adults with BD. Method: Study inclusion criteria included being ≥ 18 years old with BD Type 1 or 2, difficulties with medication adherence and actively symptomatic as measured by Brief Psychiatric Rating Scale (BPRS) score ≥ 36, Young Mania Rating Scale (YMRS) > 8 or Montgomery Asberg Depression Rating Scale (MADRS) > 8. Adherence was measured in 2 ways: 1) the self-reported Tablets Routine Questionnaire (TRQ) and 2) electronic pill container monitoring (eCap pillbox). BD symptoms and functioning were measured with the MADRS, YMRS, Clinical Global Impressions Scale (CGI), and Global Assessment of Functioning (GAF). Only screening and baseline data were examined. Results: Mean age was 42.32 (SD = 12.99) years, with 72.46% (n = 50) female and 43.48% (n = 30) non-white. Mean past 7-day percentage of days with missed BD medications using TRQ was 40.63% (SD = 32.61) and 30.30% (SD = 30.41) at screening and baseline, respectively. Baseline adherence using eCap was 42.16% (SD = 35.85) in those with available eCap data (n = 41). Worse adherence based on TRQ was significantly associated with higher MADRS (p = 0.04) and CGI (p = .03) but lower GAF (p = 0.02). eCAP measured adherence was not significantly associated with clinical variables. Conclusion: While depression and functioning were approximate markers of adherence, reliance on patient self-report or BD symptom presentation may give an incomplete picture of medication-taking behaviors.

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OBJECTIVES: To compare the prevalence of physical morbidities between older aged patients with bipolar disorder (OABD) and non-psychiatric comparisons (NC), and to analyze sex differences in prevalence. METHODS: OABD was defined as bipolar disorder among adults aged ≥50 years. Outcomes analyzed were the prevalence of diseases affecting the cardiovascular, respiratory, gastrointestinal, genitourinary, renal, musculoskeletal, and endocrine systems. The analysis used cross-sectional data of OABD participants (n = 878; mean age 60.9 ± 8.0 years, n = 496 (56%) women) from the collaborative Global Aging & Geriatric Experiments in Bipolar Disorder (GAGE-BD) dataset and NC participants recruited at the same sites (n = 355; mean age 64.4 ± 9.7 years, n = 215 (61%) women). RESULTS: After controlling for sex, age, education, and smoking history, the OABD group had more cardiovascular (odds ratio [95% confidence interval]: 2.12 [1.38-3.30]), renal (5.97 [1.31-43.16]), musculoskeletal (2.09 [1.30-3.43]) and endocrine (1.90 [1.20-3.05]) diseases than NC. Women with OABD had more gastrointestinal (1.56 [0.99-2.49]), genitourinary (1.72 [1.02-2.92]), musculoskeletal (2.64 [1.66-4.37]) and endocrine (1.71 [1.08-2.73]) comorbidities than men with OABD, when age, education, smoking history, and study site were controlled. CONCLUSIONS: This replication GAGE-BD study confirms previous findings indicating that OABD present more physical morbidities than matched comparison participants, and that this health burden is significantly greater among women.

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Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental condition with severe and life-long consequences. Adolescents and young adults represent a particularly vulnerable subgroup because of the unique demands of their developmental stage. Despite the well-known efficacy of medication treatment for ADHD, there remains a notable concern regarding poor medication adherence in this population. Objectives: This systematic literature review aimed to synthesize the existing empirical evidence on the outcomes and consequences of medication nonadherence among adolescents and young adults with ADHD. Methods: An extensive database search was conducted on September 26, 2022, with no time limits applied. The databases included Scopus, PubMed, CINAHL, Cochrane, and PsycINFO. Results: Six studies met the inclusion criteria. Each study revealed that medication nonadherence was associated with a range of adverse outcomes, including decreased academic performance, heightened familial, and psychological stress, and an increased likelihood of substance use, pregnancy, obesity, and injury. Conversely, adherence led to improvements in at least one ADHD-related outcome. Conclusions: Research exploring the consequences of suboptimal medication adherence in adolescents and young adults with ADHD is currently limited, and effective strategies to address this issue remain scarce. A thorough understanding of such consequences is critical for developing interventions aimed at improving medication adherence and mitigating the risk of adverse outcomes, especially considering the susceptibility of this population.

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The onset of the COVID-19 pandemic saw a significant surge in the utilization of telemental health (TMH) services. This narrative review aimed to investigate the efficacy of TMH for serious mood disorders prior to the COVID-19 pandemic. A search across databases was conducted for randomized controlled trials focusing on TMH interventions for mood disorders, encompassing major depressive disorder (MDD) and bipolar disorder (BD). Study and patient characteristics, interventions, and outcomes were extracted. From a pool of 2611 papers initially identified, 17 met the inclusion criteria: 14 focused on MDD, while 4 addressed BD. Among these, 6 papers directly compared TMH interventions to in-person of same treatment, revealing improved access to care and higher rates of appointment follow-up with TMH. Additionally, 6 papers comparing TMH to treatment as usual demonstrated improvements in mood outcomes. Conversely, 3 papers comparing different TMH interventions found no discernible differences in outcomes. Notably, 3 studies evaluated TMH as an adjunct to usual care, all reporting enhancements in depression outcomes. Overall, preliminary evidence suggests that prior to COVID-19, TMH interventions for serious mood disorders facilitated improved access to care and follow-up, with comparable clinical outcomes to traditional in-person interventions. The discussion addresses limitations and provides recommendations for future research in this domain.

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Performance validity tests (PVTs) aim to detect noncredible performance during neuropsychological testing. Despite their established utility, their cognitively undemanding nature and format may unintentionally reveal their purpose, leading to ongoing efforts to develop novel PVTs. In this study, we examined the ability of the embedded validity indices of the Poreh Nonverbal Memory Test (PNMT) to detect simulation. An initial sample of 61 participants was randomly assigned to either a simulation or control condition. Participants then completed the PNMT, the Test of Memory Malingering (TOMM), and the Digit Span subtest. A second validation study using 49 participants was conducted in Israel utilizing the same paradigm. In both studies, simulators were less accurate, exhibited shallow and- at times- reversed PNMT learning curves, and obtained lower scores on the delayed and recognition trials. Additionally, PNMT indices showed similar sensitivity and specificity and were highly correlated with more established validity measures. These findings, however, should be considered preliminary and await further validation in clinical settings.

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Objective: Managing bipolar disorder (BD) is particularly challenging for adolescents and young adults (AYAs) ages 16 to 21. Few interventions exist that address self-management in AYAs with BD. Thus, this study aimed to modify the customized adherence enhancement behavioral intervention for AYAs through an iterative, patient-centered process. Method: The Obesity-Related Behavioral Intervention Trials (ORBIT) model was used for intervention development. In phase 1a, adherence barriers and facilitators were identified to refine intervention content. Phase 1b occurred following curriculum modification to ensure that the modified intervention was relevant and usable by the target population. Data were collected via focus groups and interviews with AYAs with BD, parents, and providers. Transcripts were analyzed using directed content analysis. Results: Phase 1a included focus groups/interviews with AYAs (n = 10), parents (n = 4), and providers (n = 9) who described the difficulties and successes in managing BD symptoms, improving adherence, and transitioning care from caregivers. Phase 1b included an advisory board composed of 8 phase 1a participants who provided feedback on modified session activities, module delivery, and curriculum. Phase 1b involved usability testing with new participants (n = 8), revealing the need for modifiable language based on developmental level, more engaging visual images, and confirmation that topics were salient to AYAs with BD. Conclusion: Though sample sizes were small and not representative of the population of AYAs with BD, the ORBIT methodology informed the adaptation of the customized adherence enhancement intervention to improve adherence in AYAs with BD. Important next steps are to conduct a pilot randomized clinical trial of customized adherence enhancement for AYAs.

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There is growing concern about the availability of healthcare services for rural patients. This systematic literature review evaluates original research on health disparities among rural and urban populations with mental health conditions in North America. Using PRISMA guidelines, we used four electronic databases (Pubmed, Cochrane, PsychInfo, Web of Science) and hand searches and included original research conducted in the United States or Canada before July 2021 that compared health outcomes of patients with any mental health disorder in rural versus non-rural areas. Both qualitative and quantitative data were extracted including demographics, mental health condition, health disparity measure, rural definition, health outcome measures/main findings, and delivery method. To evaluate study quality, the modified Newcastle Ottawa Scale was used. Our initial search returned 491 studies and 17 studies met final inclusion criteria. Mental health disorders included schizophrenia (4 studies), PTSD (10), mood disorders (9), and anxiety disorders (6). Total sample size was 5,314,818 with the majority being military veterans. Six studies (35.2%) showed no significant rural-urban disparities while eleven (64.7%) identified at least one. Of those, nine reported worse outcomes for rural patients. The most common disparities were diagnostic differences, increased suicide rates and access problems. This review found mixed results regarding outcomes in rural patients with mental health disorders. Disparities were found regarding risk of suicide and access to services. Telehealth in addition to in person outreach to these rural communities may be alternatives to impact these outcomes.

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Objective: While medication non-adherence is common in bipolar disorder (BD), few studies have specifically assessed non-adherent BD adolescents and young adults (AYAs). This analysis, using screening and baseline data from an ongoing randomized controlled trial, examined the relationship between BD symptoms and adherence in poorly adherent AYAs. Methods: AYAs ages 13-21 had sub-optimal adherence defined as missing ⩾ 20% of prescribed BD medication. Mean sample (N = 36) age was 19.1 years (SD = 2.0), 66.7 % (N = 24) female, 25.0 % (n = 9) non-white. Adherence was measured via: 1) self-reported Tablets Routine Questionnaire (TRQ) and 2) electronic monitoring (SimpleMed pillbox). Symptoms were measured with the Hamilton Depression Rating Scale (HAM-D), the Young Mania Rating Scale (YMRS), and the Clinical Global Impression Scale (CGI). Results: Mean percentage of missed BD medications using TRQ was 34.9 (SD = 28.9) at screening and 30.6 (SD = 33.0) at baseline. Mean percentage of missed medication using SimpleMed at baseline was 42.1 (SD = 37.0). The correlation between TRQ and SimpleMed was r = 0.36 (p = 0. 13). Neither CGI nor age were correlated with adherence. Neither TRQ nor SimpleMed were significantly related to HAM-D. YMRS was positively associated with worse adherence for TRQ (r = 0.36, p = 0.03), but not significantly associated with SimpleMed. Adherence did not differ by other demographic attributes. Conclusion: Adherence levels varied widely in AYA with BD. Adherence monitoring increased adherence by approximately 4.5%, and use of electronic pill monitoring identified a greater proportion of missed medication vs. self-report. BD symptoms may not consistently identify AYA with adherence challenges.

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INTRODUCTION: Suboptimal adherence is a well-established, pervasive problem in individuals with bipolar disorder (BD) causing disability, suffering, and cost. AREAS COVERED: This review covers new research since January 2016 regarding internal (patient-centered) and external (system level) barriers and facilitators to adherence. Measures of adherence, the efficacy of psychosocial adherence enhancement interventions in individuals with BD, and, finally, novel delivery systems for BD medication are also covered. Measures of adherence continue to fall broadly into objective measures (i.e. drug levels) and more subjective, self-report measures and a combination of these likely provides the most comprehensive picture. Efficacious components of psychosocial adherence enhancement interventions include psychoeducation, motivational interviewing, and cognitive behavioral strategies, yet methods for delivery vary. Long-acting injectable (LAI) medications for BD are the drug delivery system with the most promise for BD. Combining psychosocial components with novel drug delivery systems has the potential for establishing and maintaining medication adherence. EXPERT OPINION: Psychosocial interventions improve adherence in individuals with BD. Psychoeducation is a necessary but not sufficient component in psychosocial interventions. LAIs should be considered earlier for adherence improvement than many treatment guidelines currently suggest. Comparative studies are lacking as is research into novel systems of medication delivery.

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Introduction: Given the increasing use of telepsychiatry and to serve as a reference point informing future research, our team evaluated the literature on the use of telepsychiatry for medication adherence promotion prior to the COVID-19 pandemic among patients with psychotic disorders. Methods: A search of PubMed, Cochrane, Web of Science, CINAHL, and PsycINFO was conducted using PRISMA guidelines to identify telepsychiatry interventions to enhance medication adherence in patients with primary psychotic disorders. Both quantitative and qualitative data were extracted from the identified articles including study characteristics, interventions, and outcomes. Results: In total, 230 articles were obtained through electronic literature search, and 4 articles were eventually retained that met inclusion criteria. All 4 articles were randomized controlled trials, were adjuncts to in-person usual care, used telephone platforms and targeted medication adherence. Compared to treatment as usual, 3 out of 4 studies found medication adherence was improved and 2 out of 4 studies found improved medication attitudes. Telepsychiatry appeared to be acceptable to patients with psychotic disorders. Discussion: In the pre-Covid-19 literature, telepsychiatry appears promising as an adjunct to usual care for increasing medication adherence among individuals with schizophrenia/schizoaffective disorder. However, given the limited number of papers and exclusive use on telephone-only to deliver telepsychiatry, additional research specific to telepsychiatry for patients with psychosis is needed.

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BACKGROUND: Mood-stabilizing medications are a cornerstone of treatment for people with bipolar disorder, though approximately half of these individuals are poorly adherent with their medication, leading to negative and even severe health consequences. While a variety of approaches can lead to some improvement in medication adherence, there is no single approach that has superior adherence enhancement and limited data on how these approaches can be implemented in clinical settings. Existing data have shown an increasing need for virtual delivery of care and interactive telemedicine interventions may be effective in improving adherence to long-term medication. METHODS: Customized adherence enhancement (CAE) is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention using a flexibly administered modular format that can be delivered via telehealth communications. CAE is comprised of up to four standard treatment modules including Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing. Participants will attend assigned module sessions with an interventionist based on their reasons for non-adherence and will be assessed for adherence, functioning, bipolar symptoms, and health resource use across a 12-month period. Qualitative and quantitative data will also be collected to assess barriers and facilitators to CAE implementation and reach and adoption of CAE among clinicians in the community. DISCUSSION: The proposed study addresses the need for practical adherence interventions that are effective, flexible, and designed to adapt to different settings and patients. By focusing on a high-risk, vulnerable group of people with bipolar disorder, and refining an evidence-based approach that will integrate into workflow of public-sector care and community mental health clinics, there is substantial potential for improving bipolar medication adherence and overall health outcomes on a broad level. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov NCT04622150 on November 9, 2020.

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OBJECTIVE: Mobile health tools are feasible options to encourage behavior change among patients with serious mental illness. Mobile health tools vary widely, both in platforms used and content delivered. This literature review assessed the use of text messaging interventions to promote medication adherence among patients with serious mental illness. METHODS: A systematic literature review using PRISMA guidelines examined short message service (SMS) text messaging interventions promoting medication adherence to people with a serious mental illness diagnosis. Databases included PubMed, Cochrane, CINAHL, and PsycINFO. Data extraction included demographic information, participant diagnoses, intervention components, medication class, adherence measures, research design, and study outcomes. Study quality was also assessed. RESULTS: Of 114 full-text articles screened, 10 articles were selected from nine unique interventions (N=937 people with serious mental illness). Study durations ranged from 30 days to 18 months, with frequency of SMS ranging from twice weekly to 12 times daily. Of the nine unique trials, most reported using an automated server to deliver SMS messages (N=7), two-way SMS capabilities (N=6), customized message content or timing (N=7), and additional components (e.g., provider contact, educational content, and monetary rewards) (N=7). Seven of the 10 articles reported statistically significant improvement in medication adherence and in at least one clinical outcome. CONCLUSIONS: Evidence to date indicates that text messaging interventions are feasible and appear to improve medication adherence and clinical outcomes among patients with serious mental illness. Future research should assess implementation approaches and how to scale up efforts in nonresearch settings.

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Patients with severe mental illness (SMI) who do not adhere to treatment have a lower quality of life, with more hospitalizations, interpersonal relationship conflict, homelessness, substance use problems, and incarceration compared to patients who adhere to treatment. Nonadherence to psychiatric medications has been studied for over a decade in patients diagnosed with bipolar, schizoaffective, and schizophrenia disorders with long-acting injectable antipsychotics (LAI) becoming a mainstay of adherence-focused treatment. Previous studies have shown that LAI treatment can be further optimized with the inclusion of the behavioral intervention, Customized Adherence Enhancement (CAE). It was unclear if outcomes improved similarly across the studies that varied by demographics, diagnoses, and CAE + LAI protocols. We aimed to evaluate CAE + LAI adherence outcomes in SMI by pooling three studies to better understand response to treatment in the setting of varied circumstances. Our findings show that adherence improved similarly across studies despite these differences. Furthermore, it was demonstrated that CAE + LAI improved adherence to a similar degree when primary mood and psychotic disorder cohorts were compared. As the use of LAI expands, our findings show the versatility and effectiveness of including CAE to further optimize adherence and improve other outcomes.

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BACKGROUND: Cardiovascular disease in individuals with mental health conditions such as bipolar disorder is highly prevalent and often poorly managed. Individuals with bipolar disorder face significant medication adherence barriers, especially when they are prescribed multiple medications for other health conditions including hypertension. Poor adherence puts them at a disproportionate risk for poor health outcomes. As such, there is a need for effective interventions to improve hypertension medication adherence, particularly in patients that struggle with adherence due to mental health comorbidity. METHODS: This 5-year project uses a 2-stage randomized controlled trial design to evaluate a brief, practical adherence intervention delivered via interactive text messaging (iTAB-CV) along with self-monitoring of medication taking, mood, and home blood pressure (N = 100) compared to self-monitoring alone (N = 100). Prior to randomization, all participants will view an educational video that emphasizes the importance of medication for the treatment of hypertension and bipolar disorder. Those randomized to the texting intervention will receive daily text messages with predetermined content to address 11 salient domains as well as targeted customized messages for 2 months. This group will then be re-randomized to receive either a high (gradual taper from daily to weekly texts) or low booster (weekly texts) phase for an additional 2 months. All participants will be monitored for 52 weeks. The primary outcomes are systolic blood pressure and adherence to antihypertensive medication as determined by a self-reported questionnaire and validated with an automated pill-monitoring device. Secondary outcomes include adherence to bipolar disorder medications, psychiatric symptoms, health status, self-efficacy for medication-taking behavior, illness beliefs, medication attitudes, and habit strength. DISCUSSION: This study specifically targets blood pressure and mental health symptom control in people with bipolar and includes implementation elements in the study design intended to inform future scale-up. Promising pilot data and a theoretical model, which views sustained medication-taking behavior in the context of habit formation, suggests that this remotely delivered intervention may help advance care for this high-risk population and is amenable to both scale up and easy adaptation for other groups with poor medication adherence. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov ( NCT04675593 ) on December 19, 2020.

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BACKGROUND: Chronic psychotic disorders (CPD) impose a particularly significant burden in resource-limited settings. Combining long-acting antipsychotic medication (LAI) with a customized adherence enhancement intervention (CAE-L) has potential to advance care. METHODS: Nineteen adults ≥ age 18 with CPD who self-reported missing ≥20% of antipsychotic medication within the last month were stabilized on oral haloperidol prior to transitioning to monthly haloperidol decanote for 25 weeks. Outcome evaluations were conducted at baseline and Week 25. Primary outcomes were oral medication adherence assessed via the Tablet Routines Questionnaire (TRQ) and LAI injection frequency. Secondary outcomes included CPD symptoms measured by the Brief Psychiatric Rating Scale and Clinical Global Impressions, functioning evaluated using the Social and Occupational Functioning Scale, and medication attitudes assessed with the Drug Attitudes Inventory. RESULTS: Mean sample age was 38.79 (SD = 9.31) with 18 individuals completing the study. There was one serious adverse event, a relapse into substance use, not deemed study-related. Mean endpoint LAI dosage was 65.79 mg (SD = 22.38). TRQ mean scores were 21.84 (SD =13.83) and 12.94 (SD = 11.93) at screen and baseline respectively. For only two individuals who were on concomitant oral medication at 25 weeks, TRQ change was not calculated. LAI injection frequency was 100%. Medication attitudes scores significantly improved from 7.89 (SD = 2.72) to 9.83 (SD = 0.52) (p = .001.) Changes in CPD symptoms and functioning were non-significant. CONCLUSIONS: CAE-L appears to be preliminarily feasible and acceptable in Tanzanians with CPD. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov (NCT04327843) on March 31, 2020.

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Objective: Poor adherence to antihypertensive medication occurs in 50-80% of patients. An ongoing randomized controlled trial (RCT) is evaluating a personalized mobile-health intervention in poorly adherent hypertensive persons with bipolar disorder. To enhance efficacy, the ongoing trial elicited guidance from a Stakeholder Advisory Board (SAB) comprised of patients, family members, clinicians, and health system administrators. Our goal is to describe the formation, role, decision-making process, and key contributions of the SAB as a means of demonstrating meaningful community engagement in mental health research. Methods: Using models and measures from the field of implementation science, eleven SAB members convened across three meetings followed by quantitative surveys that assessed SAB member satisfaction and engagement during the meeting. Results: Significant suggestions from the SAB included 1) expanding inclusion/exclusion criteria, and 2) operationalizing remote implementation of the RCT. Primary study implementation challenges identified by the SAB were 1) participant difficulty engaging in the mHealth intervention, and 2) identification of procedures for monitoring participant adherence to the RCT protocol and contacting under-engaged participants. Quantitative surveys indicated that all SAB members believed that the objectives of the meetings were clear, perceived that they were able to participate in the discussions, and that they were heard. Conclusions: Increasing evidence demonstrates the feasibility of engaging with SABs in clinical research and that this process improves intervention design, increases participant engagement, reduces mental health-related stigma, and produces more effective implementation strategies. We encourage future investigators to use an implementation science framework in partnership with SABs to refine their proposed interventions and improve clinical outcomes.

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Objective: People with bipolar disorder (BD) often have difficulty with medication adherence. This pilot trial combined a behavioral customized adherence enhancement (CAE) approach with long-acting injectable (LAI) antipsychotic medication and assessed effects on adherence, BD symptoms, and functional status.Methods: This 6-month prospective, uncontrolled trial of the intervention (CAE with LAI) in 30 poorly adherent individuals with BD assessed adherence using the Tablets Routine Questionnaire (TRQ) and symptoms using the Brief Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), and Clinical Global Impressions (CGI). Functioning was assessed via the Social and Occupational Functioning Assessment Scale (SOFAS) and Global Assessment of Functioning (GAF). Assessments were conducted at screening, baseline, week 12, and week 24 (6 months). The LAI was aripiprazole once monthly. The study was conducted between April 2018 and May 2020.Results: The mean age of the sample was 49.5 years (SD = 9.3), and 56.7% were Black. Nine individuals (30%) terminated the study prematurely, 1 due to side effects (tremor). The mean LAI dose was 314.3 mg (SD = 96.4). The proportion of missed medications in the past week (mean TRQ) from screen to 24 weeks significantly improved from 50.1% (SD 24.8) to 16.9% (SD = 27.0) (P < .001), and past month TRQ improved from 40.6% (SD = 23.8) to 19.2% (SD = 24.0) (a trend for significance, P = .0599). TRQ change from baseline to 24 weeks was not significant. There were significant improvements on the BPRS (P < .001), MADRS (P = .01), YMRS (P < .001), CGI (P < .001), SOFAS (P < .001), and GAF (P < .001).Conclusion: A personalized intervention to address adherence barriers combined with LAI can improve recovery outcomes in high-risk individuals with BD.Trial Registration: ClinicalTrials.gov Identifier: NCT03408873.

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BACKGROUND: The burden of chronic psychotic disorders (CPDs) in sub-Saharan Africa (SSA) is significant. Poorly medically adherent patients are more likely to have worse outcomes and require more resources. However, factors impacting effective treatment of CPD in this population are unclear. AIM: Examine the relationship between alcohol use and disease management and compare alcohol risk stratification between the Alcohol Use Disorders Identification Test (AUDIT) and Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in poorly medication adherent Tanzanians with CPD. SETTING: Muhimbili National Hospital and ambulatory clinics in Dar es Salaam, Tanzania. METHODS: 100 Tanzanians with CPDs and suboptimal medication adherence were dichotomized into low and moderate-to-high risk alcohol use based on AUDIT scores and compared regarding medication attitudes, adherence and psychiatric symptoms. Patients completed the ASSIST for comparison to AUDIT risk stratification. RESULTS: Moderate-to-high risk alcohol users had worse medication attitudes (p < 0.01), medication adherence (previous week, p = 0.01; previous month, p < 0.001), and psychiatric symptoms (p = 0.03). They were younger, predominately male and more likely to have a family history of alcohol abuse. A logistic regression analysis found age, gender and family history of abuse as significant predictors of hazardous alcohol use (p = 0.02, 0.02, < 0.01, respectively). Risk stratification between AUDIT and ASSIST aligned in 85% of participants. CONCLUSION: Alcohol use is an important consideration in treating poorly adherent Tanzanians with CPD. The ASSIST was comparable to the AUDIT in stratifying risky alcohol use with the additional benefit of screening for other substances.