Essential data dimensions for prospective international data collection in older age bipolar disorder (OABD): Recommendations from the GAGE-BD group.

BACKGROUND: By 2030, over 50% of individuals living with bipolar disorder (BD) are expected to be aged ≥50 years. However, older age bipolar disorder (OABD) remains understudied. There are limited large-scale prospectively collected data organized in key dimensions capable of addressing several fundamental questions about BD affecting this subgroup of patients. METHODS: We developed initial recommendations for the essential dimensions for OABD data collection, based on (1) a systematic review of measures used in OABD studies, (2) a Delphi consensus of international OABD experts, (3) experience with harmonizing OABD data in the Global Aging & Geriatric Experiments in Bipolar Disorder Database (GAGE-BD, n ≥ 4500 participants), and (4) critical feedback from 34 global experts in geriatric mental health. RESULTS: We identified 15 key dimensions and variables within each that are relevant for the investigation of OABD: (1) demographics, (2) core symptoms of depression and (3) mania, (4) cognition screening and subjective cognitive function, (5) elements for BD diagnosis, (6) descriptors of course of illness, (7) treatment, (8) suicidality, (9) current medication, (10) psychiatric comorbidity, (11) psychotic symptoms, (12) general medical comorbidities, (13) functioning, (14) family history, and (15) other. We also recommend particular instruments for capturing some of the dimensions and variables. CONCLUSION: The essential data dimensions we present should be of use to guide future international data collection in OABD and clinical practice. In the longer term, we aim to establish a prospective consortium using this core set of dimensions and associated variables to answer research questions relevant to OABD.

A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project.

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.

An interventional pilot of customized adherence enhancement combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania.

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.

A randomized controlled trial of self-management for people with epilepsy and a history of negative health events (SMART) targeting rural and underserved people with epilepsy: a methodologic report.

BACKGROUND: Many people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a remotely delivered, Web-based group format 12-week self-management program (SMART) conducted in Northeast Ohio, a primarily urban and suburban community, demonstrated improved outcomes in negative health events such as depression symptoms and quality of life. However, there is a paucity of research addressing the needs of PLWE in rural settings. METHODS: The present study leverages collaboration between investigators from 2 mid-western US states (Ohio and Iowa) to replicate testing of the SMART intervention and prioritize delivery to PLWE in rural and semi-rural communities. In phase 1, investigators will refine the SMART program using input from community stakeholders. A Community Advisory Board will then be convened to help identify barriers to trial implementation and strategies to overcome barriers. In phase 2, the investigators will conduct a 6-month prospective randomized control trial of the SMART program compared to 6-month waitlist controls, with the primary outcome being changes in negative health events defined as seizure, self-harm attempt, emergency department visit, or hospitalization. Additional outcomes of interest include quality of life and physical and mental health functioning. The study will also assess process measures of program adopters and system end-users to inform future outreach, education, and self-management strategies for PLWE. DISCUSSION: The method of this study employs lived experience of PLWE and those who provide care for PLWE in rural and underserved populations to refine a remotely delivered Web-based self-management program, to improve recruitment and retention, and to deliver the intervention. Pragmatic outcomes important to PLWE, payers, and policymakers will be assessed. This study will provide valuable insights on implementing future successful self-management programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04705441 . Registered on January 12, 2021.

Long-Acting Injectable Antipsychotic Medication Plus Customized Adherence Enhancement in Poor Adherence Patients With Bipolar Disorder.

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.

A Program to Increase the Appropriate Use of Long-Acting Injectable Antipsychotic Medications in Community Settings.

OBJECTIVE: The Multilevel Facilitation of Long-Acting Antipsychotic Medication Program (MAP) is a novel intervention to increase the appropriate use of long-acting injectable (LAI) antipsychotics in community mental health clinics. The authors investigated the feasibility of MAP, facilitators and barriers to use, and preliminary impact on LAI medication use. METHODS: Two clinics in Texas and two in Ohio serving 750 and 617 individuals with schizophrenia receiving oral antipsychotics, respectively, were asked to change clinical procedures for 1 year by using either the not receiving optimum benefit (NOB) checklist or the checklist plus MAP. Providers used the NOB checklist to identify individuals who could benefit from switching to LAI antipsychotics. MAP clinics used the NOB checklist plus nonbranded academic detailing for providers and a shared-decision-making video and tool for consumers. Use of MAP components was tracked, and barriers and facilitators were collected quarterly. Antipsychotic prescription counts were provided by participating clinics. RESULTS: Barriers to use of MAP included loss of local champions and administrators, difficulty with provider buy-in, limited availability of peer specialists, and a lack of infrastructural support to integrate MAP into clinic flow. Higher scores on the NOB checklist were associated with more provider LAI medication offers and greater patient acceptance of LAI antipsychotics. LAI medication use increased in clinics over time, but it is unclear whether this increase was due to MAP. CONCLUSIONS: Changing MAP components to fit local procedures and to circumvent unique barriers could aid implementation. Further research should investigate the potential impact of MAP components on LAI medication use.

Alcohol use in Tanzanians with chronic psychotic disorders and poor medication adherence.

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.

The Relationship Between Medication Attitudes and Medication Adherence Behavior in Adults With Bipolar Disorder.

The relationship between medication attitudes and adherence as well as reliable measures of medication attitudes need further study. This study examined the psychometric properties of the Attitudes Toward Mood Stabilizers Questionnaire (AMSQ) in bipolar participants and the relationship between medication attitudes and adherence, measured by the self-reported Tablets Routine Questionnaire (TRQ). Inclusion criteria included mood stabilizer treatment and 20% or more medication nonadherence. Measures were given pretreatment and posttreatment. Average age was 47 years; majority were female (69%), African American (67%), and unmarried (53%). AMSQ's test-retest reliability was ρ = 0.73 (p < 0.001). AMSQ correlated with TRQ (rs = 0.20, p < 0.01) at baseline. Factor analysis identified three factors: positive/favorable attitudes, negative/critical attitudes, and unintentional nonadherence. Change in AMSQ across time correlated with change in TRQ. The AMSQ is valid psychometrically and is sensitive to change. Medication attitudes are related to adherence behavior. Interventions should include targeting specific domains of medication attitudes, such as illness knowledge.

Depressive Symptoms in Older versus Younger People with Epilepsy: Findings from an Integrated Epilepsy Self-Management Clinical Research Dataset.

AIM: There are limited data on psychological outcomes in older people with epilepsy (PWE). This analysis, from a large pooled dataset of clinical studies from the Managing Epilepsy Well (MEW) Network, examined clinical variables including depressive symptom severity, quality of life and epilepsy self-management competency among older (age 55+) vs younger (

Self-management for adults with epilepsy: Aggregate Managing Epilepsy Well Network findings on depressive symptoms.

OBJECTIVE: To assess depressive symptom outcomes in a pooled sample of epilepsy self-management randomized controlled trials (RCTs) from the Managing Epilepsy Well (MEW) Network integrated research database (MEW DB). METHODS: Five prospective RCTs involving 453 adults with epilepsy compared self-management intervention (n = 232) versus treatment as usual or wait-list control outcomes (n = 221). Depression was assessed with the nine-item Patient Health Questionnaire. Other variables included age, gender, race, ethnicity, education, income, marital status, seizure frequency, and quality of life. Follow-up assessments were collapsed into a visit 2 and a visit 3; these were conducted postbaseline. RESULTS: Mean age was 43.5 years (SD = 12.6), nearly two-thirds were women, and nearly one-third were African American. Baseline sample characteristics were mostly similar in the self-management intervention group versus controls. At follow-up, the self-management group had a significantly greater reduction in depression compared to controls at visit 2 (P < .0001) and visit 3 (P = .0002). Quality of life also significantly improved in the self-management group at visit 2 (P = .001) and visit 3 (P = .005). SIGNIFICANCE: Aggregate MEW DB analysis of five RCTs found depressive symptom severity and quality of life significantly improved in individuals randomized to self-management intervention versus controls. Evidence-based epilepsy self-management programs should be made more broadly available in neurology practices.

A customized adherence enhancement program combined with long-acting injectable antipsychotic medication (CAE-L) for poorly adherent patients with chronic psychotic disorder in Tanzania: A pilot study methodological report.

Chronic psychotic disorders (CPDs) occur worldwide and cause significant burden including reduced quality of life and functional impairment. Care for CPD includes psychosocial and pharmacologic interventions (i.e. antipsychotic drugs) and ongoing health monitoring. This is challenging in resource-limited settings where staff are sparse and/or undertrained. Importantly, mental health human resource needs predict continued deficits compounded by increasing disease burden. A U.S. team recently developed and tested a CPD treatment approach that combines the use of long-acting antipsychotic medication (LAI) with a brief and practical customized adherence enhancement behavioral intervention (CAE-L). This report describes the methodological details of an ongoing, first-ever refinement and preliminary testing of CAE-L in poorly adherent patients with CPD in Tanzania. Additional innovative elements include: 1) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, and 2) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication). The study procedures are intended to pave the way for implementing a large-scale intervention trial for CPD in the Tanzanian setting. An important component of this project is capacity building to help form the next generation of care providers. Visit exchanges modeled on a successful NIH-funded Medical Education Partnership Initiative (MEPI) template will also use the U.S. and Tanzanian teams to share expertise, problem-solve, and plan iterative refinements of project deliverables. Taken together, this project has potential to advance the care of people with CPD in Tanzania and has high generalizability to Sub-Saharan Africa and other lower-resource settings.

One-year follow-up of a remotely delivered epilepsy self-management program in high-risk people with epilepsy.

OBJECTIVE: "Self-management for people with epilepsy and a history of negative health events" (SMART) is a novel group-format epilepsy self-management intervention demonstrated to reduce negative health events (NHEs) such as accidents, emergency department visits, and seizures in adults with epilepsy in a 6-month prospective randomized controlled trial (RCT); SMART also reduced depressive symptoms and improved health functioning and quality of life. This report describes the longer-term (12-month) post-efficacy RCT outcomes in adults with epilepsy who received SMART. METHODS: After completing a 6-month, prospective RCT that demonstrated efficacy of SMART vs 6-month waitlist control (WL), adults ≥18 years of age with epilepsy were followed for an additional 12 months. Individuals originally randomized to WL received the 8-week SMART intervention immediately following the conclusion of the RCT. For this long-term extension analysis, assessments were conducted at 24 weeks (the 6-month primary outcome time-point of the efficacy RCT), at 32 weeks for individuals originally randomized to WL, and at 48 weeks and 72 weeks for all individuals. Outcomes assessed included past 6-month NHE counts, depressive symptoms assessed with the 9-item Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS), and quality of life assessed with the 10-item Quality of Life in Epilepsy (QOLIE-10). RESULTS: At the beginning of this long-term observational period (24-week follow-up time point for the original RCT), there were 50 individuals in the group originally randomized to SMART and 52 originally randomized to WL. Mean age was 41.4 years, 70% women (N = 71), 64% (N = 65) African-American, and 8% Hispanic (N = 8). Study attrition from week 24 to week 72 was 8% in the arm originally randomized to SMART and 17% in the arm originally randomized to WL. During the 12-month observation period (24 weeks to 72 weeks), there were a total of 44 serious adverse events and 4 deaths, none related to study participation. There was no significant change in total past 6-month NHE counts in the group originally randomized to SMART, although the group had significantly reduced 6-month seizure counts. The group originally randomized to WL, who received SMART during this observational period, had a reduction in total NHE counts. The group originally randomized to SMART had relatively stable levels on other outcome variables except for a trend for improved MADRS (p = 0.08). In the group originally randomized to WL, there were significant improvements in PHQ-9 (p = 0.01), MADRS (p ≤ 0.01), and QOLIE-10 (p = 0.004). CONCLUSIONS: This post-RCT extension study suggests that adults with epilepsy who participate in the SMART intervention sustain clinical effects at 1-year follow-up and may have incremental improvements in seizure frequency and mood. Future research needs to identify opportunities for scale-up and outreach to other high-risk groups with epilepsy.

Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder.

OBJECTIVE: This study evaluated the feasibility, acceptability, and preliminary efficacy of psychoeducation plus an automated text messaging intervention (Individualized Texting for Adherence Building-Cardiovascular [iTAB-CV]) to improve adherence to antihypertensives and bipolar disorder medication. METHODS: After a psychoeducation program, iTAB-CV was administered for 2 months. In month 1, participants received one educational-motivational and one mood rating text daily. In month 2, medication reminders were added. RESULTS: The sample (N=38) was 74% African American and 53% women, with a mean±SD age of 51.53±9.06. Antihypertensive nonadherence decreased from a mean of 43%±23% to 21%±18% at 12 weeks (χ2=34.6, df=3, p<0.001). Systolic blood pressure decreased from a mean of 144.8±15.5 mmHg to 136.0±17.8 mmHg (χ2=17.6, df=3, p<.001). Retention was 100%. CONCLUSIONS: In this uncontrolled trial, participants were highly engaged and medication adherence and reduced systolic blood pressure were sustained after psychoeducation plus iTAB-CV. Because iTAB-CV is automated and delivered remotely, it has the potential to reach a large and challenging population.

Functional health status of adults with serious mental illness and diabetes mellitus: A latent profile analysis.

OBJECTIVE: Adults with serious mental illness are at increased risk for diabetes mellitus and diabetes-related complications. This article classifies subgroups among people with serious mental illness and comorbid diabetes with respect to functional status and examines differences among those groups. METHODS: This analysis used a baseline sample of 157 adults with serious mental illness and diabetes mellitus enrolled in a National Institute of Health-funded research study. Latent profile analysis was used to distinguish health status profiles and investigate how these subgroups differed across assessment domains. RESULTS: Participants with depression, schizophrenia, and bipolar disorder (n = 157) were included in the study. Mean age was 52.9 years (standard deviation = 9.8), and 62 (40%) were African American. From the latent profile analysis, a three-class model appeared to provide the best fit. Class 1 (34.9%) had a very low functional health status approximately two standard deviations below the general population mean. Class 2 (43.7%) had a low functional status approximately one standard deviation below the general mean. Class 3 (21.4%) had moderate functional status with scores near population mean. Groups differed on measures of personal characteristics, clinical status and symptom severity, self-care behaviors, and environmental characteristics. CONCLUSIONS: Although individuals with schizophrenia generally have poor prognosis once they develop diabetes, latent profile analysis identified distinct health status subgroups. Although all three groups demonstrated illness burden, the pattern of differences between these groups across measures may suggest the need for different interventions for highly diverse adults who received care within safety-net primary care.

Enhancing Multi-Center Patient Cohort Studies in the Managing Epilepsy Well (MEW) Network: Integrated Data Integration and Statistical Analysis.

Self-management techniques that assist patients with chronic conditions, such as epilepsy, diabetes, and arthritis, play an important role in managing and caring for their conditions. The US Center for Disease Control and Prevention (CDC)-funded Managing Epilepsy Well (MEW) Network consists of 11 study sites across the US that aims to develop and disseminate self-management techniques for epilepsy patients. Epilepsy affects more than 65 million patients worldwide with serious negative impact on their own as well as their family member's quality of life. Taking advantage of advances in biomedical informatics, the MEW Network has created an integrated database (MEW DB) using a common data model and two tiers of study variables. The MEW DB consists of 1680 patient data records covering a wide range of patient population nationwide. Therefore, there is growing interest in the use of the MEW DB for different cohort query analysis. To address the challenges in: (1) selecting appropriate MEW research studies based on inclusion/exclusion criteria; (2) creating a patient cohort for given research hypothesis; and (3) performing appropriate statistical tests; we have developed an integrated data query and statistical analysis informatics tool called Insight. The Insight platform features an intuitive user interface to support the three phases of study selection, patient cohort creation, and statistical testing with the use of an epilepsy domain ontology to support ontology-driven query expansion. We evaluate the Insight platform using two user evaluation methods of "first click testing" and "user satisfaction survey". In addition, we performed a time performance test of the Insight platform using four patient datasets and three statistical test. The results of the user evaluation show that Insight platform is strongly approved by the users and the results of the time performance show that there is marginal difference in performance as the volume of patient data increases in the MEW DB.

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

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. 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). 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.

A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy.

OBJECTIVE: Despite advances in care, many people with epilepsy have negative health events (NHEs) such as accidents, emergency department visits, and poor quality of life. "Self-management for people with epilepsy and a history of negative health events" (SMART) is a novel group format epilepsy self-management intervention. A community participatory approach informed the refinement of SMART, which was then tested in a 6-month randomized controlled trial of SMART (n = 60) versus waitlist control (WL, n = 60). METHODS: Participants were adults aged ≥18 years with epilepsy and an NHE within the past 6 months (seizure, accident, self-harm attempt, emergency department visit, or hospitalization). Assessments were conducted at screening, baseline, 10 weeks, and 24 weeks (6 months). Primary outcome was 6-month change in total NHE count. Additional outcomes included depression on the nine-item Patient Health Questionnaire and Montgomery-Asberg Depression Rating Scale, quality of life on the 10-item Quality of Life in Epilepsy, functioning on the 36-item Short-Form Health Survey, and seizure severity on the Liverpool Seizure Severity Scale. RESULTS: Mean age was 41.3 years (SD = 11.82), 69.9% were African American, 74.2% were unemployed, and 87.4% had an annual income < US$25 000; 57.5% had a seizure within 30 days of enrollment. Most NHEs were seizures. Six-month study attrition was 14.2% overall and similar between arms. Individuals randomized to SMART had greater reduction in total median NHEs from baseline to 6 months compared to WL (P = 0.04). SMART was also associated with improved nine-item Patient Health Questionnaire (P = 0.032), Montgomery-Asberg Depression Rating Scale (P = 0.002), 10-item Quality of Life in Epilepsy (P < 0.001), and 36-item Short-Form Health Survey (P = 0.015 physical health, P = 0.003 mental health) versus WL. There was no difference in seizure severity. SIGNIFICANCE: SMART is associated with reduced health complications and improved mood, quality of life, and health functioning in high-risk people with epilepsy. Additional efforts are needed to investigate potential for scale-up.

Race analysis in an African American sample with serious mental illness and comorbid diabetes.

OBJECTIVES: Targeted Training in Illness Management (TTIM) focuses on enhancing care engagement for people living with serious mental illness and diabetes. This secondary analysis from a 60-week, randomized controlled trial of TTIM versus treatment as usual evaluated racial subgroup outcomes. METHOD: Demographics, clinical characteristics, and diabetes status were evaluated for those self-identifying as non-Hispanic White, African American, and Hispanic. Longitudinal response to TTIM was evaluated using a multiple domain risk index. Due to their small sample size; those identifying as Hispanic were excluded from this analysis. RESULTS: Non-Hispanic White participants had greater baseline socioeconomic advantages. Baseline risk scores, glycosylated hemoglobin (HbA1c) values, and HbA1c differences over time were similar for African American and non-Hispanic White participants. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: African American participants living with serious mental illness and diabetes receiving TTIM did as well as non-Hispanic White participants. Inclusive approaches that feature peer support and are situated in safety-net health care settings need to be further investigated with respect to potentially impacting health disparities. (PsycINFO Database Record