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Alex Kopelowicz,1 Ross A Baker,2 Cathy Zhao,2 Claudette Brewer,3 Erica Lawson,3 Timothy Peters-Strickland2 1David Geffen School of Medicine, University of California, Los Angeles, CA, 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, 3Otsuka Pharmaceutical Development and Commercialization Inc., Rockville, MD, USA Background: Medication nonadherence is common in the treatment of serious mental illness (SMI) and leads to poor outcomes. The digital medicine system (DMS) objectively measures adherence with oral aripiprazole in near-real time, allowing recognition of adherence issues. This pilot study evaluated the functionality of an integrated call center in optimizing the use of the DMS. Materials and methods: An 8-week, open-label, single-arm trial at four US sites enrolled adults with bipolar I disorder, major depressive disorder, and schizophrenia on stable oral aripiprazole doses and willing to use the DMS (oral aripiprazole + ingestible event marker [IEM], IEM-detecting skin patch, and software application). Integrated call-center functionality was assessed based on numbers and types of calls. Ingestion adherence with prescribed treatment (aripiprazole + IEM) during good patch wear and proportion of time with good patch wear (days with ≥80% patch data or detected IEM) were also assessed. Results: All enrolled patients (n=49) used the DMS and were included in analyses; disease duration overall approached 10 years. For a duration of 8 weeks, 136 calls were made by patients, and a comparable 160 calls were made to patients, demonstrating interactive communication. The mean (SD) number of calls made by patients was 2.8 (3.5). Approximately half of the inbound calls made by patients occurred during the first 2 weeks and were software application- or patch-related. Mean ingestion adherence was 88.6%, and corresponding good patch wear occurred on 80.1% of study days. Conclusion: In this pilot study, the integrated call center facilitated DMS implementation in patients with SMI on stable doses of oral aripiprazole. In clinical practice, the call center and the DMS will facilitate objective measurement of adherence and potentially improve rates of adherence in patients with SMI. Keywords: schizophrenia, bipolar I disorder, major depressive disorder, digital medicine, adherence

ObjectiveThis study aimed to investigate the effect of brief reminder-focused positive psychiatry and suicide prevention (RFPP-S) on suicidal ideation, posttraumatic stress disorder (PTSD) symptoms, and clinical outcomes among youths with PTSD treated in psychiatric emergency rooms.MethodsThis study included youths with PTSD and suicidality who received either RFPP-S (N=50) or treatment as usual (N=150). The Columbia Suicide Severity Rating Scale (C-SSRS), Clinician-Administered PTSD Scale for children and adolescents, University of California, Los Angeles Trauma Reminder Inventory, Patient Health Questionnaire-9, Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment Scale, and positive psychiatry test batteries were administered at baseline, on day 2, and 1 week and 1 month after discharge.ResultsOn day 2, the RFPP-S group showed a greater reduction in PTSD symptoms (55%) and reactivity to trauma and loss reminders (80%) compared with the control group (10% for both) (p=0.001). A significantly greater reduction in C-SSRS score for RFPP-S (80%), compared with treatment as usual (15%), was noted (p=0.001), and RFPP-S showed more rapid stabilization (mean±SD=2.0±0.5 days) and enhanced postdischarge follow-up (100%) compared with treatment as usual (5.0±2.0 days and 50%, respectively) (p

PurposeThis study (a) documents the duration of untreated psychosis (DUP) and (b) examines both social and clinical correlates of DUP in a sample of U.S. Latinxs with first-episode psychosis (FEP).MethodsData were collected for a longitudinal study evaluating a community education campaign to help primarily Spanish-speaking Latinxs recognize psychotic symptoms and reduce the DUP, or the delay to first prescribed antipsychotic medication after the onset of psychotic symptoms. Social and clinical variables were assessed at first treatment presentation. A sequential hierarchical regression was conducted using √DUP to identify independent predictors of the DUP. A structural equation model was used to explore the association between DUP predictors, DUP, and clinical and social correlates.ResultsIn a sample of 122 Latinxs with FEP, the median DUP was 39 weeks (M = 137.78, SD = 220.31; IQR = 160.39–5.57). For the full sample, being an immigrant and having self-reported relatively poor English-speaking proficiency and self-reported strong Spanish-speaking proficiency were related to a longer delay to first prescribed medication after psychosis onset. For the immigrant subgroup, being older at the time of migration was related to a longer delay. Self-reported English-speaking proficiency emerged as an independent predictor of the DUP. Although the DUP was not related to symptomatology, it was associated with poorer social functioning. Low self-reported English-speaking ability is associated with poorer social functioning via the DUP.ConclusionLatinxs with limited English language skills are especially at high risk for experiencing prolonged delays to care and poor social functioning. Intervention efforts to reduce the delay in Latinx communities should pay particular attention to this subgroup.

BackgroundThe rate of Type 2 diabetes mellitus (T2DM) among Mexican American individuals is 16.3%, about twice that of non-Hispanic White individuals. While a number of education approaches have been developed and shown to improve diabetes self-management behaviors and glycemic control for Spanish-speaking Latinx patients with T2DM, there is little research to guide health practitioners regarding which interventions to apply and when so that resources are used efficiently, and treatment outcomes are maximized. ObjectiveThis study aimed to describe an adaptive intervention that integrates community mental health workers, diabetes nurse educators, family members, and patients as partners in care while promoting diabetes self-management for Mexican American individuals with T2DM. The project incorporates four evidence-based, culturally tailored treatments to determine what sequence of intervention strategies work most efficiently and for whom. Given the increasing prevalence of T2DM, achieving better control of diabetes and lowering the associated medical complications experienced disproportionally by Mexican American individuals is a public health priority. MethodsFunded by the National Institute of Nursing Research (National Institutes of Health grant R01 NR015809), this project used a sequential multiple assignment randomized trial and included 330 Spanish-speaking Latinx patients with T2DM. In the first phase of the study, subjects were randomly assigned to an evidence-based diabetes self-management educational program called Tomando Control delivered in a group format for 6, biweekly 1.5-hour sessions, led either by a community health worker or a diabetes nurse educator. In the second phase of the study, those subjects who did not improve their diabetes self-management behaviors were rerandomized to receive either an augmented version of Tomando Control or a multifamily group treatment focused on problem-solving. The primary outcome measure was the “Summary of Diabetes Self-Care Activities.” Evaluations were made at baseline and at 3, 6, and 12 months. ResultsThis study was funded in June 2016 for a period of 5 years. Institutional review board approval was obtained in November 2016. Between March 2017 and September 2020, a total of 330 patients were recruited from the outpatient primary care clinics of Olive View-UCLA Medical Center, with a brief hiatus between May 2020 and July 2020 due to COVID-19 restrictions. The study interventions were completed in December 2020. Data collection began in March 2017 and was completed in December 2021. Data analysis is expected to be completed in Spring 2023, and results will be published in Fall 2023. ConclusionsThe results of this trial should help practitioners in selecting the optimal approach for improving diabetes self-management in Spanish-speaking, Latinx patients with T2DM. Trial RegistrationClinicalTrials.gov NCT03092063; https://clinicaltrials.gov/ct2/show/NCT03092063 International Registered Report Identifier (IRRID)DERR1-10.2196/44793

If treatments for cognitive impairment are to be utilized successfully, clinicians must be able to determine whether they are effective and which patients should receive them. In order to develop consensus on these issues, the International Society for CNS Clinical Trials and Methodology (ISCTM) held a meeting of experts on March 20, 2014, in Washington, DC. Consensus was reached on several important issues. Cognitive impairment and functional disability were viewed as equally important treatment targets. The group supported the notion that sufficient data are not available to exclude patients from available treatments on the basis of age, severity of cognitive impairment, severity of positive symptoms, or the potential to benefit functionally from treatment. The group reached consensus that cognitive remediation is likely to provide substantial benefits in combination with procognitive medications, although a substantial minority believed that medications can be administered without nonpharmacological therapy. There was little consensus on the best methods for assessing cognitive change in clinical practice. Some participants supported the view that performance-based measures are essential for measurement of cognitive change; others pointed to their cost and time requirements as evidence of impracticality. Interview-based measures of cognitive and functional change were viewed as more practical, but lacking validity without informant involvement or frequent contact from clinicians. The lack of consensus on assessment methods was viewed as attributable to differences in experience and education among key stakeholders and significant gaps in available empirical data. Research on the reliability, validity, sensitivity, and practicality of competing methods will facilitate consensus.

Lack of knowledge about psychosis, a condition oftentimes associated with serious mental illness, may contribute to disparities in mental health service use. Psychoeducational interventions aimed at improving psychosis literacy have attracted significant attention recently, but few have focused on the growing numbers of ethnic and linguistic minorities in countries with large immigrant populations, such as the United States. This paper reports on 2 studies designed to evaluate the effectiveness of a DVD version of La CLAve, a psychoeducational program that aims to increase psychosis literacy among Spanish-speaking Latinos. Study 1 is a randomized control study to test directly the efficacy of a DVD version of La CLAve for Spanish speakers across a range of educational backgrounds. Fifty-seven medical students and 68 community residents from Mexico were randomly assigned to view either La CLAve or a psychoeducational program of similar length regarding caregiving. Study 2 employed a single-subjects design to evaluate the effectiveness of the DVD presentation when administered by a community mental health educator. Ninety-three Spanish-speakers from San Diego, California completed assessments both before and after receiving the DVD training. Results from these 2 studies indicate that the DVD version of La CLAve is capable of producing a range of psychosis literacy gains for Spanish-speakers in both the United States and Mexico, even when administered by a community worker. Thus, it has potential for widespread dissemination and use among underserved communities of Spanish-speaking Latinos and for minimizing disparities in mental health service use, particularly as it relates to insufficient knowledge of psychosis.

Although it is clear that expressed emotion (EE) is associated with the course of schizophrenia, proposed models for this association have struggled to account for the relationship between the EE index of emotional overinvolvement (EOI) and relapse. To expand our understanding of the EOI-relapse association, we first attempted to replicate the finding that the EOI-relapse association is curvilinear among 55 Mexican-Americans with schizophrenia and their caregiving relatives. Second, we evaluated whether the caregivers perception of their ill relatives efficacy may account for the EOI-relapse association. Our results comport with past findings with regard to the curvilinear nature of the EOI-relapse association among Mexican-Americans and suggest that EOI may only seem to be a risk factor of relapse because of its strong association with a true risk factor for relapse (i.e., caregivers perception of their ill relatives efficacy).

Although it is clear that expressed emotion (EE) is associated with the course of schizophrenia, proposed models for this association have struggled to account for the relationship between the EE index of emotional overinvolvement (EOI) and relapse. To expand our understanding of the EOI-relapse association, we first attempted to replicate the finding that the EOI-relapse association is curvilinear among 55 Mexican-Americans with schizophrenia and their caregiving relatives. Second, we evaluated whether the caregivers' perception of their ill relative's efficacy may account for the EOI-relapse association. Our results comport with past findings with regard to the curvilinear nature of the EOI-relapse association among Mexican-Americans and suggest that EOI may only seem to be a risk factor of relapse because of its strong association with a true risk factor for relapse (i.e., caregivers' perception of their ill relative's efficacy).

Growing awareness of health and health care disparities highlights the importance of including information about race, ethnicity, and culture (REC) in health research. Reporting of REC factors in research publications, however, is notoriously imprecise and unsystematic. This article describes the development of a checklist to assess the comprehensiveness and the applicability of REC factor reporting in psychiatric research publications. The 16-item GAP-REACH checklist was developed through a rigorous process of expert consensus, empirical content analysis in a sample of publications (N = 1205), and interrater reliability (IRR) assessment (N = 30). The items assess each section in the conventional structure of a health research article. Data from the assessment may be considered on an item-by-item basis or as a total score ranging from 0% to 100%. The final checklist has excellent IRR (κ = 0.91). The GAP-REACH may be used by multiple research stakeholders to assess the scope of REC reporting in a research article.

The U.S. Surgeon General's report "Mental Health: Culture, Race and Ethnicity--A Supplement to Mental Health: A Report of the Surgeon General" (U.S. Department of Health and Human Services, 2001) identified significant disparities in mental health care for Latinos and recommended directions for future research and mental health services. We update that report by reviewing five groundbreaking research projects on the mental health of Latinos that were published since 2001. National studies of adults and children, longitudinal designs, and analyses of Latino subgroups characterize these investigations. Despite the increasing sophistication of disparities research, these landmark studies, as well as the research in the supplemental report, can be characterized as documenting disparities in care. We argue that the next wave of research should give greater attention to reducing and eliminating disparities. Accordingly, we apply Rogler and Cortes's (1993) framework of pathways to care to the study of Latinos with schizophrenia. Specifically, we draw on research regarding the recognition of illness, social networks (families) and their association with the course of illness, and interventions. We illustrate examples at each pathway that have the potential to reduce disparities. We argue that implementing interventions synchronously across multiple pathways has considerable potential to reduce and eventually eliminate disparities in mental health care. (Contains 2 footnotes.)

The authors developed and tested a 35-min psychoeducational program with the goal of increasing Spanish-speaking persons' literacy of psychosis. The program uses popular cultural icons derived from music, art, and videos, as well as a mnemonic device--La CLAve (The Clue)--to increase (a) knowledge of psychosis, (b) efficacy beliefs that one can identify psychosis in others, (c) attributions to mental illness, and (d) professional help-seeking. Assessments were conducted before and after administering the program to both community residents (n = 57) and family caregivers of persons with schizophrenia (n = 38). For community residents, the authors observed increases across the 4 domains of symptom knowledge, efficacy beliefs, illness attributions, and recommended help-seeking. For caregivers, increases were observed in symptom knowledge and efficacy beliefs. La CLAve is a conceptually informed psychoeducational tool with a developing empirical base aimed at helping Spanish-speaking Latinos with serious mental illness obtain care in a timely manner. (Contains 7 footnotes, 2 tables, and 3 figures.)