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Objective There is limited information regarding the tolerability of electroconvulsive therapy (ECT) combined with pharmacotherapy in elderly adults with major depressive disorder (MDD). Addressing this gap, we report acute neurocognitive outcomes from Phase 1 of the Prolonging Remission in Depressed Elderly (PRIDE) study. Methods Elderly adults (age ≥60) with MDD received an acute course of 6 times seizure threshold right unilateral ultrabrief pulse (RUL-UB) ECT. Venlafaxine was initiated during the first treatment week and continued throughout the study. A comprehensive neurocognitive battery was administered at baseline and 72 hours following the last ECT session. Statistical significance was defined as a two-sided p-value of less than 0.05. Results A total of 240 elderly adults were enrolled. Neurocognitive performance acutely declined post ECT on measures of psychomotor and verbal processing speed, autobiographical memory consistency, short-term verbal recall and recognition of learned words, phonemic fluency, and complex visual scanning/cognitive flexibility. The magnitude of change from baseline to end for most neurocognitive measures was modest. Conclusion This is the first study to characterize the neurocognitive effects of combined RUL-UB ECT and venlafaxine in elderly adults with MDD and provides new evidence for the tolerability of RUL-UB ECT in an elderly sample. Of the cognitive domains assessed, only phonemic fluency, complex visual scanning, and cognitive flexibility qualitatively declined from low average to mildly impaired. While some acute changes in neurocognitive performance were statistically significant, the majority of the indices as based on the effect sizes remained relatively stable.

Background About 13% of African Americans and 13% of Hispanics have diabetes, compared to 8% of non-Hispanic Whites (NHWs). This is more pronounced in the elderly where about 25–30% of those aged 65 and older have diabetes. Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH. Specifically, psychosocial factors (such as cognitive dysfunction, functional impairment, and social isolation) impacting this population may be under-addressed due to numerous medical concerns addressed during the clinical visit. The long-term goal of the project is to identify strategies to improve glycemic control and reduce diabetes complications and mortality in African Americans and Hispanics/Latinos with type 2 diabetes. Methods This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with type 2 diabetes mellitus (T2DM) (HOME DM-BAT). Two hundred, aged 65 and older and with an HbA1c ≥8%, will be randomized into one of two groups: (1) an intervention using in-home, nurse telephone-delivered diabetes education, and behavioral activation or (2) a usual care group using in-home, nurse telephone-delivered, health education/supportive therapy. Participants will be followed for 12 months to ascertain the effect of the intervention on glycemic control, blood pressure, and low-density lipoprotein (LDL) cholesterol. The primary hypothesis is low-income, minority seniors with poorly controlled type 2 diabetes randomized to HOME DM-BAT will have significantly greater improvements in clinical outcomes at 12 months of follow-up compared to usual care. Discussion Results from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with uncontrolled type 2 diabetes mellitus and inform strategies to improve glycemic control and reduce diabetes complications in minority elderly with T2DM. Trial registration ClinicalTrials.govNCT04203147). Registered on December 18, 2019, with the National Institutes of Health Clinical Trials Registry.

Introduction A novel randomized controlled trial tested the efficacy of a technology-assisted case management program in a low income, rural population previously where nurses titrated medication over the phone instead of in a clinic. The primary analysis showed significant improvement in glycemic control at 6 months post-randomization decreasing hemoglobin A1c by 1%. This study aimed to test if the intervention was also effective at decreasing blood pressure without compromising quality of life. Methods A total of 113 adults with poorly controlled diabetes (hemoglobin A1c ≥ 8%) were randomly assigned to the technology-assisted case management intervention or usual care. Participants received a 2-in-1 telehealth system to monitor glycemic and blood pressure control, which was uploaded daily to a central server. A nurse case manager was trained to titrate medication under physician supervision every 2 weeks based on the readings. Outcomes were blood pressure and quality of life (12-item Short-Form Health Survey) at 6 months. Baseline adjusted mixed models using a random intercept were used to evaluate change at 6 months for the technology-assisted case management intervention group compared to usual care. Results There were no statistically significant differences in systolic blood pressure, physical component of quality of life, or mental component of quality of life between the technology-assisted case management and control group. However, there was a significant change in diastolic blood pressure over time, with the technology-assisted case management group decreasing at 6 months ( p = .05), whereas the control group remained stable. Conclusions Technology-assisted case management by a nurse with medication titration under physician supervision was efficacious in improving diastolic blood pressure without compromising quality of life in low-income rural adults with diabetes.

Objective There is limited information regarding neurocognitive outcomes of right unilateral ultrabrief pulse width electroconvulsive therapy (RUL-UB ECT) combined with pharmacotherapy in older adults with major depressive disorder. We report longitudinal neurocognitive outcomes from Phase 2 of the Prolonging Remission in Depressed Elderly (PRIDE) study. Method After achieving remission with RUL-UB ECT and venlafaxine, older adults (≥60 years old) were randomized to receive symptom-titrated, algorithm-based longitudinal ECT (STABLE) plus pharmacotherapy (venlafaxine and lithium) or pharmacotherapy-only. A comprehensive neuropsychological battery was administered at baseline and throughout the 6-month treatment period. Statistical significance was defined as a p-value of less than 0.05 (two-sided test). Results With the exception of processing speed, there was statistically significant improvement across most neurocognitive measures from baseline to 6-month follow-up. There were no significant differences between the two treatment groups at 6 months on measures of psychomotor processing speed, autobiographical memory consistency, short-term and long-term verbal memory, phonemic fluency, inhibition, and complex visual scanning and cognitive flexibility. Conclusion To our knowledge, this is the first report of neurocognitive outcomes over a 6-month period of an acute course of RUL-UB ECT followed by one of 2 strategies to prolong remission in older adults with major depression. Neurocognitive outcome did not differ between STABLE plus pharmacotherapy versus pharmacotherapy alone over the 6-month continuation treatment phase. These findings support the safety of RUL-UB ECT in combination with pharmacotherapy in the prolonging of remission in late-life depression.

Background There is strong evidence that disparities in the burden of diabetes exist by both race and poverty. Food insecurity, or an inability to or limitation in accessing nutritionally adequate food, is an important modifiable social determinant of health, particularly in adults with chronic disease. African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure. Methods We describe a 4-year ongoing randomized controlled trial, which will test the separate and combined efficacy of monthly food vouchers and monthly food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, African Americans with type 2 diabetes mellitus using a 2 × 2 factorial design. Three hundred African American adults with clinical diagnosis of diabetes and HbA1c ≥ 8% will be randomized into one of four groups: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus stock boxes; and 4) diabetes education plus combined food vouchers and stock boxes. Our primary hypothesis is: among low-income, food insecure, African Americans with type 2 diabetes, those receiving diabetes education enhanced with food supplementation (food vouchers alone, stock boxes alone, or combination) will have significantly greater reduction in HbA1c at 12 months compared to those receiving diabetes education only. Discussion Results from this study will yield valuable insight currently lacking on how best to design and deliver diabetes interventions to low-income, food insecure, African Americans with diabetes that takes into account both clinical and social determinants of health. Trial registration This study was registered on November 29, 2019 with the United States National Institutes of Health Clinical Trials Registry ( ClinicalTrials.gov identifier# NCT04181424 ).

Evidence suggests multicomponent interventions are essential to improve outcomes in minority groups. This RCT tested a multicomponent intervention (TIDES) including diabetes education and skills training by telephone and a telehealth system to monitor glycemic and blood pressure control in African Americans (AA) with poorly controlled type 2 diabetes. Two hundred AA with HbA1c >= 8 were randomized to TIDES or usual care with primary outcome HbA1c at 12-months in the intent to treat population. Baseline adjusted random intercept model evaluated reduction in HbA1c for TIDES compared to usual care. Per protocol samples and baseline adjusted marginal models were used as sensitivity analyses. Study maintained a 90% retention rate at 12-months. HbA1c at 3 months was marginally statistically significantly lower compared to usual care (p=0.06), however, at 12-months there was no statistically significant difference (p=0.67). See Figure 1. Per protocol samples and marginal models showed similar results. Results from a multicomponent RCT found a more immediate drop in HbA1c during the intervention period compared to usual care, but no significant differences at 12-months. Possible co-interventions occurring in the primary care clinic at the time of the study and low intensity booster sessions may explain results and have implications for future diabetes education trials. Disclosure L.E. Egede: None. R.G. Knapp: None. R.J. Walker: None. E. Garacci: None. J.S. Williams: None. Funding National Institutes of Health (R01DK098529)

A novel RCT tested the efficacy of a technology-assisted case management (TACM) program in a low-income, rural population previously where nurses titrated medication over the phone instead of in a clinic. The primary analysis showed significant improvement in glycemic control at 6-months post-randomization dropping HbA1c by 1%. This study aimed to test if the intervention was also effective at dropping blood pressure without compromising quality of life. One hundred and thirteen adults with poorly controlled diabetes (HbA1c>= 8%) were randomly assigned to the TACM intervention or usual care. Participants received a two-in-one telehealth system to monitor glycemic and blood pressure control, which uploaded daily to a central server. A nurse case manager was trained to titrate medication under the supervision of an internist and an endocrinologist every 2 weeks based on the readings. Outcomes were blood pressure and quality of life (SF-12) at 6-months. Baseline adjusted mixed models using a random intercept were used to evaluate change at 6-months for the TACM intervention group compared to usual care. There were no statistically significant differences in systolic blood pressure, physical component of quality of life, or mental component of quality of life between the TACM and control group. However, there was a significant change in diastolic blood pressure over time, with the TACM group decreasing at 6-month (p=0.02), whereas the control group remained stable (p=0.53). Diastolic blood pressure decreased 5.22 mm Hg at 6-months in the TACM group (p=0.04). Technology-assisted case management by a nurse with medication titration under physician supervision was efficacious in improving diastolic blood pressure without compromising quality of life in low-income rural adults with diabetes. Disclosure L.E. Egede: None. R.G. Knapp: None. R.J. Walker: None. E. Garacci: None. J.S. Williams: None. Funding U.S. Department of Defense (W81XWH-10-2-0057)

OBJECTIVE: Antidepressant medications have a variety of effects on sleep, apart from their antidepressant effects. It is unknown whether electroconvulsive therapy (ECT) has effects on perceived sleep in depressed patients. This secondary analysis examines the effects of ECT on perceived sleep, separate from its antidepressant effects. METHOD: Elderly patients with major depressive disorder, as defined by DSM-IV, received open-label high-dose, right unilateral ultrabrief pulse ECT, combined with venlafaxine, as part of participating on Phase 1 of the NIMH-supported study “Prolonging Remission in Depressed Elderly” (PRIDE). Phase 1 of PRIDE participant enrollment period extended from February 2009 to August 2014. Depression severity was measured with the Hamilton Rating Scale for Depression-24 item (HRSD(24)), and measures of insomnia severity were extracted from the HRSD(24.) Participants were characterized at baseline as either ‘high-insomnia’ or ‘low-insomnia’ subtypes, based upon the sum of the three HRSD(24) sleep items as either 4–6, or 0–3, respectively. Insomnia scores were followed during ECT, and were adjusted for the sum of all the HRSD(24) non-sleep items. Generalized linear models were used for longitudinal analysis of insomnia scores. RESULTS: Two hundred and forty patients participated, with 48.3% in the high-insomnia and 51.7% in the low-insomnia group. Although there was a reduction in the insomnia scores in the high-insomnia group, only 12.4% of them experienced remission of their insomnia after a course of ECT, despite an increase in utilization of sleep aids across the course of ECT, from 8.6% to 23.2%. The degree of improvement in insomnia symptoms paralleled the degree of improvement in non-insomnia symptoms. A “low” amount of improvement on the sum of the HRSD-non-insomnia items (HRSD-sleep) was accompanied by a “low” amount of improvement in insomnia scores (change of −1.6 ± 1.2, p

Objective To analyze the impact of telepsychology and same-room care on functioning, satisfaction, and perception of care based on a noninferiority trial of psychotherapy delivered via telemedicine or same-room care to elderly patients with depression. Methods 241 elderly patients with depression (meeting DSM-IV diagnostic criteria) were randomly assigned to either telemedicine (n = 120) or same-room treatment (n = 121) between April 1, 2007, and July 31, 2011. The primary outcomes included quality of life (36-item Short Form Survey [SF-36]), satisfaction (Charleston Psychiatric Outpatient Satisfaction Scale), treatment credibility, and service delivery perception scores obtained at 4 weeks, 8 weeks, 3 months, and 12 months. Comparisons of intervention means were carried out at each time point using independent sample t tests and SAS Procedure MIANALYZE to combine results across the multiply imputed complete data sets. If significant differences were detected for a given outcome within a domain, a Bonferroni correction was applied to determine if significance was maintained. Results None of the SF-36 scores showed a significant difference between the 2 treatment groups by the end of the study period, with little significance shown throughout the intermediate time points. Similarly, over all time points, there was no statistically significant difference in patient satisfaction or treatment credibility. Conclusions This study found that telemedicine is a viable alternative modality for providing evidence-based psychotherapy for elderly patients with depression. Results provide evidence that quality of life and satisfaction with care are not adversely influenced by the decision to use a telehealth modality instead of in-person treatment, and, as a result, resources can be devoted to offering services in patients' homes through telemedicine. Trial registration ClinicalTrials.gov identifier: NCT00324701.

The current veteran population has grown significantly as a result of 3 recent major conflicts: Vietnam, Persian Gulf War, and Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF). Despite ...

Objective There are few empirical data regarding effective treatment of trauma-related symptoms among individuals with severe mental illness (SMI; e.g., bipolar disorder, schizophrenia). This under-examined clinical issue is significant because rates of trauma and PTSD are higher among individuals with SMI relative to the general population, and there are sufficient data to suggest that PTSD symptoms exacerbate the overall course and prognosis of SMI. Method 34 veterans with SMI received prolonged exposure (PE) for PTSD using an open trial study design. Results Data suggest that PE is feasible to implement, well-tolerated, and results in clinically significant decreases in PTSD severity in patients with SMI. Mean CAPS scores improved 27.2 points from baseline to immediate post [95% CI for mean change: −44.3, - 10.1; p = 0.002, paired t-test, and treatment gains were maintained at 6 months [mean change from baseline to 6-months, −16.1; 95% CI: −31.0, –1.2; p = 0.034, paired t-test]. Conclusions The current data support the use of exposure-based interventions for PTSD among individuals with SMI and highlight the need for rigorous randomized efficacy trials investigating frontline PTSD interventions in this patient population.

Objective Combat veterans returning to society with impairing mental health conditions such as PTSD and major depression (MD) report significant barriers to care related to aspects of traditional psychotherapy service delivery (e.g., stigma, travel time, and cost). Hence, alternate treatment delivery methods are needed. Home-based telehealth (HBT) is one such option; however, this delivery mode has not been compared to in person, clinic-based care for PTSD in adequately powered trials. The present study was designed to compare relative noninferiority of evidence-based psychotherapies for PTSD and MD, specifically Behavioral Activation and Therapeutic Exposure (BA-TE), when delivered via HBT versus in person, in clinic delivery. Method A repeated measures (i.e., baseline, posttreatment, 3-, 6-month follow-up) randomized controlled design powered for noninferiority analyses was used to compare PTSD and MD symptom improvement in response to BA-TE delivered via HBT versus in person, in clinic conditions. Participants were 232 veterans diagnosed with full criteria or predefined subthreshold PTSD. Results PTSD and MD symptom improvement following BA-TE delivered by HBT was comparable to that of BA-TE delivered in person at posttreatment and at 3- and 12-month follow-up. Conclusion Evidence-based psychotherapy for PTSD and depression can be safely and effectively delivered via HBT with clinical outcomes paralleling those of clinic-based care delivered in person. HBT, thereby, addresses barriers to care related to both logistics and stigma.

Introduction Alzheimer's disease (AD) is the most prevalent neurodegenerative disease of aging, affecting approximately 5.4 million individuals in the US, and predicted to increase to 13.8 million by 2050. Occurring in over 90% of AD patients, neuropsychiatric symptoms such as agitation, depression and apathy, contribute to caregiver burden and increase patient morbidity and mortality. With no FDA-approved options available, treatments for severe agitation in people with advanced dementia are limited, with modest evidence for efficacy and substantial safety concerns. Behavioral therapies are recommended as first-line treatments for agitation in AD; however, they require substantial time to take effect and may be less efficacious for the most severely agitated patients. Psychotropic medications, especially antipsychotics, are widely used off-label to treat agitation in AD even with documented limitations in efficacy and safety concerns. Therefore, new treatments for severe agitation in AD refractory to standard interventions are timely and warranted. Randomized controlled trials have demonstrated the safety and efficacy of electroconvulsive therapy (ECT) for the treatment of severe psychiatric disorders of late life, including depression, mania and psychosis. Recently, small open label studies suggest efficacy and safety of ECT for agitation in individuals with AD who are refractory to standard therapies. The present randomized controlled trial builds upon prior work and aims to determine the efficacy and safety of ECT for severe agitation in moderate to severe stage AD, while also examining the durability of the acute treatment effect in an exploratory maintenance naturalistic design. Methods We describe an NIA-funded multi-site, single blind, randomized trial of ECT plus usual care (UC) versus Simulated-ECT (S-ECT) plus UC. We will enroll 200 inpatients with severe agitation and moderate to severe dementia, who have not responded well to prior trials of psychotropic medications. Our primary efficacy outcome measure is the Cohen Mansfield Agitation Inventory (CMAI), and the Neuropsychiatric Inventory – Clinician Version (NPI-C), Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC), and Pittsburgh Agitation Scale (PAS) will be secondary measures. Safety and tolerability will be assessed with the Severe Impairment Battery – 8 item (SIB-8), the Confusion Assessment Method (CAM), and adverse event monitoring. Results Preliminary open-label data from our team suggests acute ECT treatment is safe and effective in reducing agitation in this population as measured by the CMAI, PAS, CGI, and adverse event monitoring. A multi-site, prospective case series investigated ECT treatment in 23 consecutive inpatients with dementia and severe agitation who did not benefit from standard behavioral interventions and pharmacotherapy. Eighteen of the 23 subjects experienced a significant reduction in agitation from baseline to discharge on the CMAI. In a retrospective chart review study of 16 patients undergoing ECT for agitation related to AD, only two experienced more than transient confusion post-ECT that required treatment, and no other clinically significant adverse events were noted in this group. We hypothesize ECT+UC will be more efficacious in reducing severe agitation in AD subjects than S-ECT+UC, as measured by our primary and secondary efficacy measures, and that there will be no difference in tolerability/safety outcomes for ECT+UC and S-ECT+UC as measured by cognitive decline (SIB-8), development of delirium (CAM), and serious adverse event monitoring. Conclusions This innovative study will fill a gap in the current clinical practice of treating severe agitation in AD using a rigorous methodological approach thus providing evidence for a new therapeutic application (severe agitation in AD) of a well-studied, established, and safe treatment (ECT). Study findings may demonstrate support for a new therapeutic use of ECT for severe agitation in AD. Successful management of neuropsychiatric symptoms reduces long-term care placement, decreases the risk of mortality, and enhances patient and caregiver quality-of-life. Such an approach has the potential to offer enormous relief to the substantial socioeconomic burden of AD-related behavioral disturbances. This research was funded by National Institute of Aging R01 AG061100-01

We examined whether electroconvulsive therapy (ECT) plus medications ("STABLE + PHARM" group) had superior HRQOL compared with medications alone ("PHARM" group) as continuation strategy after successful acute right unilateral ECT for major depressive disorder (MDD). We hypothesized that scores from the Medical Outcomes Study Short Form-36 (SF-36) would be higher during continuation treatment in the "STABLE + PHARM" group versus the "PHARM" group. The overall study design was called "Prolonging Remission in Depressed Elderly" (PRIDE). Remitters to the acute course of ECT were re-consented to enter a 6 month RCT of "STABLE + PHARM" versus "PHARM". Measures of depressive symptoms and cognitive function were completed by blind raters; SF-36 measurements were patient self-report every 4 weeks. Participants were 120 patients60 years old. Patients with dementia, schizophrenia, bipolar disorder, or substance abuse were excluded. The "PHARM" group received venlafaxine and lithium. The "STABLE + PHARM" received the same medications, plus 4 weekly outpatient ECT sessions, with additional ECT session as needed. Participants were mostly female (61.7%) with a mean age of 70.5 ± 7.2 years. "STABLE + PHARM" patients received 4.5 ± 2.5 ECT sessions during Phase 2. "STABLE + PHARM" group had 7 point advantage (3.5-10.4, 95% CI) for Physical Component Score of SF-36 (P 0.0001), and 8.2 point advantage (4.2-12.2, 95% CI) for Mental Component Score (P 0.0001). Additional ECT resulted in overall net health benefit. Consideration should be given to administration of additional ECT to prevent relapse during the continuation phase of treatment of MDD. CLINICAL TRIALS.GOV: NCT01028508.

Purpose – The purpose of this paper is to evaluate provider outcomes in response to two modes of suicide prevention training (e-learning and in-person) and a control group. The Collaborative Assessment and Management of Suicidality (CAMS) was adapted for e-learning delivery to US Veterans Administration mental health providers. Outcomes include: self-evaluated beliefs, ability, and self-efficacy in managing suicidal patients. Design/methodology/approach – This study used a multicenter, randomized, cluster design to test the effectiveness of e-learning vs in-person conditions CAMS for changes in provider outcomes. Findings – Survey scores showed significant improvements for both the e-learning vs control and the in-person vs control between pre-intervention and post-intervention; however, the e-learning and in-person conditions were not significantly different from each other. Research limitations/implications – Limitations of the study include that there were drop-outs over the study period and the survey questions may not have captured all of the aspects of the CAMS training. Practical implications – Results suggest that e-learning training modules can provide comparable outcomes to in-person training for suicide prevention. Social implications – More providers may have accessible training materials for managing suicidal patients. Originality/value – Currently practicing providers now can choose between two equivalent training modalities for improving the management of suicidality in their patients.

To assess the efficacy of Bounce Back Now (BBN), a modular, Web-based intervention for disaster-affected adolescents and their parents.A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and several areas in Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study Web portal irrespective of mental health status at baseline. Families who accessed the Web portal were assigned randomly to 1 of 3 groups: BBN, which featured modules for adolescents and parents targeting adolescents' mental health symptoms; BBN plus additional modules targeting parents' mental health symptoms; or assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression.Nearly 50% of families accessed the Web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B = -0.24, SE = 0.08, p.01) and depressive symptoms (B = -0.23, SE = 0.09, p.01). Post hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental versus control conditions at 12-month follow-up (PTSD: B = -0.36, SE = 0.19, p = .06; depressive symptoms: B = -0.42, SE = 0.19, p = 0.03). A time × condition interaction also was found that favored the BBN versus BBN + parent self-help condition for PTSD symptoms (B = 0.30, SE = 0.12, p = .02) but not depressive symptoms (B = 0.12, SE = 0.12, p = .33).Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters.Web-based Intervention for Disaster-Affected Youth and Families; http://clinicaltrials.gov; NCT01606514.

Objective We evaluated the impact of telemedicine-delivered behaviour activation treatment (BAT) on glycemic control in a subgroup of older adults with diabetes who participated in a randomized controlled trial for depression. Research design and methods We randomized older adults with major depression to same-room or telemedicine BAT. Each group received eight weekly sessions. For the subgroup analysis, we identified individuals with type 2 diabetes and obtained hemoglobin A1c at baseline and 12 months’ follow-up. We used mixed-effects models (MEM) for repeated measures analysis to compare the longitudinal mean A1c. We estimated model-derived mean A1c values and considered an adjusted model to account for baseline health status. Results We included 90 individuals with type 2 diabetes of the original 241 in the subgroup analysis (43 in telemedicine and 47 in same room). Treatment groups were not significantly different at baseline for demographics, depression, anxiety or A1c levels (telemedicine 6.9 vs. same room 7.3, p = 0.19). Baseline mean A1c for the telemedicine group remained at 6.9 (55 mmol/mol) at 12 months, whereas baseline mean A1c for the same-room group increased to 7.7 (61 mmol/mol). Longitudinal trajectories of model-derived mean A1c indicated a significant main effect of treatment group on mean A1c value at study end (difference = −0.82, 95% CI −1.41, −0.24). Adjusted analyses gave comparable results. Conclusions Telemedicine-delivered BAT was superior to same room in achieving lower mean A1c values in participants with type 2 diabetes, suggesting BAT-delivered via telemedicine is a viable treatment option for adults with diabetes.

To assess the efficacy of technology-assisted case management (TACM) with medication titration by nurses using guideline-based algorithms, under physician supervision in improving glycemic control in low-income rural adults with poorly controlled type 2 diabetes.Adults (aged ≥18 years) from the southeastern United States with hemoglobin A1c [HbA1c] ≥8% were randomized to TACM or usual care. Evidence-based guidelines were used to develop medication titration algorithms in conjunction with clinic physicians. Participants were given a telehealth device that uploaded blood glucose and blood pressure readings daily to a central server. A nurse case manager was trained on the algorithms and authorized to titrate medications every 2 weeks based on the algorithm under the supervision of an internist and an endocrinologist. Participants were assessed at baseline, 3 months, and 6 months. The primary outcome was HbA1c at 6-months postrandomization in the intent-to-treat (ITT) population.One hundred thirteen participants were randomized to either TACM intervention or usual care. Based on ITT population after multiple imputation, the analysis of covariance with baseline HbA1c as covariate showed that HbA1c at 6 months for TACM was significantly lower compared to the usual care group (-0. 99, P = 0.024). Moreover, longitudinal mixed effects analysis suggested that the rate of decline in HbA1c over time for TACM was significantly faster compared to the usual care group (-0.16, P = 0.038). Results based on per-protocol population were similar.Technology-assisted case management by a nurse with medication titration under physician supervision is efficacious in improving glycemic control in low-income rural adults with poorly controlled type 2 diabetes.

Objective: Few empirical studies have examined the feasibility of trauma-focused treatment among individuals with schizophrenia. This lack of research is important given the substantial overlap of trauma exposure and subsequent PTSD with psychotic spectrum disorders, and the potential for PTSD to complicate the course and prognosis of schizophrenia and other variants of severe mental illness. Method: As part of a larger study, 14 veterans with a psychotic spectrum disorder were enrolled to receive prolonged exposure (PE) for PTSD within a single arm open trial study design. Patient reactions and responses to PE were examined using feasibility indices such as attrition, survey reactions, and treatment expectancy; pre and post changes in PTSD severity and diagnostic status; and thematic interviews conducted post intervention. Results: Quantitative and qualitative data indicate that implementation of PE is feasible, subjectively well-tolerated, and may result in clinically significant reductions in PTSD symptoms in patients with psychotic spectrum disorders. Conclusions: Consistent with treatment outcome data in clinical populations with a broader range of severe mental illnesses, the current results support the use of PTSD exposure-based interventions, such as PE, for individuals with psychotic spectrum disorders.

Due to the gap in suicide-specific intervention training for mental health students and professionals, e-learning is one solution to improving provider skills in the Veterans Affairs (VA) health system. This study focused on the development and evaluation of an equivalent e-learning alternative to the Collaborative Assessment and Management of Suicidality (CAMS) in-person training approach at a Veteran Health Affairs medical center. The study used a multicenter, randomized, cluster, and three group design. the development of e-CAMS was an iterative process and included pilot testing. Eligible and consenting mental health providers, who completed a CAMS pre-survey, were randomized. Provider satisfaction was assessed using the standard VA evaluation of training consisting of 20 items. Two post training focus groups, divided by learning conditions, were conducted to assess practice adoption using a protocol focused on experiences with training and delivery of CAMS. A total of 215 providers in five sites were randomized to three conditions: 69 to e-learning, 70 to in-person, 76 to the control. The providers were primarily female, Caucasian, midlife providers. Based on frequency scores of satisfaction items, both learning groups rated the trainings positively. In focus groups representing divided by learning conditions, participants described positive reactions to CAMS training and similar individual and institutional barriers to full implementation of CAMS. This is the first evaluation study of a suicide-specific e-learning training within the VA. The e-CAMS appears equivalent to the in-person CAMS in terms of provider satisfaction with training and practice adoption, consistent with other comparisons of training deliveries across specialty areas. Additional evaluation of provider confidence and adoption and patient outcomes is in progress. The e-CAMS has the potential to provide ongoing training for VA and military mental health providers and serve as a tutorial for psychiatrists in preparation for specialty boards.

This is the first randomized controlled trial to evaluate non-inferiority of Prolonged Exposure (PE) delivered via home-based telehealth (HBT) compared to standard in-person (IP) PE. One-hundred thirty two Veterans recruited from a Southeastern Veterans Affairs Medical Center and affiliated University who met criteria for posttraumatic stress disorder (PTSD) were randomized to receive PE via HBT or PE via IP. Results indicated that PE-HBT was non-inferior to PE-IP in terms of reducing PTSD scores at post-treatment, 3 and 6 month follow-up. However, non-inferiority hypotheses for depression were only supported at 6 month follow-up. HBT has great potential to reduce patient burden associated with receiving treatment in terms of travel time, travel cost, lost work, and stigma without sacrificing efficacy. These findings indicate that telehealth treatment delivered directly into patients' homes may dramatically increase the reach of this evidence-based therapy for PTSD without diminishing effectiveness.

OBJECTIVE: The Prolonging Remission in Depressed Elderly (PRIDE) study evaluated the efficacy of right unilateral ultrabrief pulse electroconvulsive therapy (ECT) combined with venlafaxine for the treatment of geriatric depression. METHOD: PRIDE was a two-phase multisite study. Phase 1 was an acute course of right unilateral ultrabrief pulse ECT, combined with open-label venlafaxine at seven academic medical centers. In phase 2 (reported separately), patients who had remitted were randomly assigned to receive pharmacotherapy (venlafaxine plus lithium) or pharmacotherapy plus continuation ECT. In phase 1, depressed patients received high-dose ECT (at six times the seizure threshold) three times per week. Venlafaxine was started during the first week of treatment and continued throughout the study. The primary outcome measure was remission, assessed with the 24-item Hamilton Depression Rating Scale (HAM-D), which was administered three times per week. Secondary outcome measures were post-ECT reorientation and safety. Paired t tests were used to estimate and evaluate the significance of change from baseline in HAM-D scores. RESULTS: Of 240 patients who entered phase 1 of the study, 172 completed it. Overall, 61.7% (148/240) of all patients met remission criteria, 10.0% (24/240) did not remit, and 28.3% (68/240) dropped out; 70% (169/240) met response criteria. Among those who remitted, the mean decrease in HAM-D score was 24.7 points (95% CI=23.4, 25.9), with a mean final score of 6.2 (SD=2.5) and an average change from baseline of 79%. The mean number of ECT treatments to remission was 7.3 (SD=3.1). CONCLUSIONS: Right unilateral ultrabrief pulse ECT, combined with venlafaxine, is a rapidly acting and highly effective treatment option for depressed geriatric patients, with excellent safety and tolerability. These data add to the evidence base supporting the efficacy of ECT to treat severe depression in elderly patients.

Patients with Major Depressive Disorder (MDD) referred for electroconvulsive therapy (ECT) have poorer Health Related Quality of Life (HRQOL), compared with other patients with MDD, but ECT is associated with significant and durable improvement in HRQOL. However, no prior research has focused exclusively on elderly patients with MDD receiving ECT.HRQOL data from 240 depressed patients over the age of 60 was measured with the Medical Outcomes Study Short Form 36 (SF-36). The SF-36 was measured before and after a course of acute ECT. Predictors of change in HRQOL scores were identified by generalized linear modeling.At baseline, participants showed very poor HRQOL. After treatment with ECT, the full sample showed marked and significant improvement across all SF-36 measures, with the largest gains seen in dimensions of mental health. Across all participants, the Physical Component Summary (PCS) score improved by 2.1 standardized points (95% CI, 0.61,3.56), while the Mental Component Summary (MCS) score improved by 12.5 points (95% CI, 7.2,10.8) Compared with non-remitters, remitters showed a trend toward greater improvement in the PCS summary score of 2.7 points (95%CI, -0.45, 5.9), while the improvement in the MCS summary score was significantly greater (8.5 points, 95% CI, 4.6,12.3) in the remitters than non-remitters. Post-ECT SF-36 measurements were consistently and positively related to baseline scores and remitter/non-remitter status or change in depression severity from baseline. Objective measures of cognitive function had no significant relationships to changes in SF-36 scores.This study's limitations include that it was an open label study with no comparison group, and generalizability is limited to elderly patients.ECT providers and elderly patients with MDD treated with ECT can be confident that ECT will result in improved HRQOL in the short-term. Attaining remission is a key factor in the improvement of HRQOL. Acute changes in select cognitive functions were outweighed by improvement in depressive symptoms in determining the short term HRQOL of the participants treated with ECT.

Combat veterans returning to society with impairing mental health conditions such as PTSD and major depression (MD) report significant barriers to care related to aspects of traditional psychotherapy service delivery (e.g., stigma, travel time, and cost). Hence, alternate treatment delivery methods are needed. Home-based telehealth (HBT) is one such option; however, this delivery mode has not been compared to in person, clinic-based care for PTSD in adequately powered trials. The present study was designed to compare relative noninferiority of evidence-based psychotherapies for PTSD and MD, specifically Behavioral Activation and Therapeutic Exposure (BA-TE), when delivered via HBT versus in person, in clinic delivery.A repeated measures (i.e., baseline, posttreatment, 3-, 6-month follow-up) randomized controlled design powered for noninferiority analyses was used to compare PTSD and MD symptom improvement in response to BA-TE delivered via HBT versus in person, in clinic conditions. Participants were 232 veterans diagnosed with full criteria or predefined subthreshold PTSD.PTSD and MD symptom improvement following BA-TE delivered by HBT was comparable to that of BA-TE delivered in person at posttreatment and at 3- and 12-month follow-up.Evidence-based psychotherapy for PTSD and depression can be safely and effectively delivered via HBT with clinical outcomes paralleling those of clinic-based care delivered in person. HBT, thereby, addresses barriers to care related to both logistics and stigma.

Objective We sought to examine the relationship of seizure threshold (ST) to age and other demographic characteristics in a large sample where ST was determined by the dose titration (DT) method. We also compared the resulting stimulation levels to estimates predicted by an age-based formula, the half-age (HA) method.

Bailine S, Fink M, Knapp R, Petrides G, Husain MM, Rasmussen K, Sampson S, Mueller M, McClintock SM, Tobias KG, Kellner CH. Electroconvulsive therapy is equally effective in unipolar and bipolar depression. Objective: To determine the relative efficacy of electroconvulsive therapy (ECT) in the treatment of bipolar (BP) and unipolar (UP) depressive illness and clarify its role in BP depression. Method: Patients referred for ECT with both UP and BP depressions. [classified by Structured Clinical Interview for DSM (SCID-I) criteria for history of mania] were included in a multi-site collaborative, double-masked, randomized controlled trial of three electrode placements – right unilateral, bifrontal or bitemporal – in a permutated block randomization scheme. Results: Of 220 patients, 170 patients (77.3%) were classified as UP and 50 (22.7%) as BP depression in the intent-to-treat sample. The remission and response rates and numbers of ECT for both groups were equivalent. Conclusion: Both UP and BP depressions remit with ECT. Polarity is not a factor in the response rate. In this sample ECT did not precipitate mania in depressed patients. Treatment algorithms for UP and BP depression warrant re-evaluation.

Effective strategies to prolong remission after electroconvulsive therapy (ECT) are urgently needed. Fixed schedules for continuation ECT (C-ECT) cannot adapt to early signs of impending relapse. Symptom-Titrated, Algorithm-Based Longitudinal ECT (STABLE) is proposed as a novel patient-focused approach to individualize the ECT schedule. In STABLE, the ECT schedule adapts to symptom fluctuations to prevent overtreatment of those who do not need it and to recapture response in those who might have otherwise relapsed with a rigid dosing schedule. Here we back-test STABLE to optimize the algorithm for subsequent testing in a prospective trial.Three variations of the STABLE algorithm, differing in cutoff points to trigger or withhold additional ECT, were back-tested in a data set of 89 patients randomized to the C-ECT arm in the CORE (Consortium for Research on ECT) Study comparing C-ECT with combination pharmacotherapy.The selected algorithm identified 100% of patients who ultimately relapsed as requiring additional ECT at an average of 2.2 weeks before relapse, while exposing 20% of sustained remitters to additional ECT. Other variations either failed to capture impending relapse or exposed an unacceptably large percentage of patients to potentially unnecessary ECT.This patient-focused approach to relapse prevention is an attempt to provide the first operationalized guidance to the field regarding how to conduct C-ECT. The effectiveness of this approach should be tested in a randomized controlled trial.

Objective The authors examine the differences in outcome between black and white patients receiving electroconvulsive therapy (ECT) as a part of the Consortium for Research on Electroconvulsive Therapy multisite study. Methods A total of 624 patients were enrolled in an National Institute of Mental Health (NIMH)-funded, randomized, controlled ECT trial comparing the efficacy of continuation ECT versus continuation pharmacotherapy between 1997 and 2004. This analysis focuses on the 32 black and 483 white patients who participated in phase I of the study. The authors compared baseline demographic and clinical variables and acute outcomes of these 2 groups. Results Compared with whites, far fewer blacks participated in the study. Those who did were less likely to have failed adequate medication trials and were more likely to have psychotic features. Their initial 24-item Hamilton Rating Scale for Depression scores were higher than those of the whites, and they showed a greater reduction in these 24-item Hamilton Rating Scale for Depression scores by the end of the treatment period. Although sample size limited the statistical significance of the findings, black patients also showed a higher rate of remission after an acute phase of ECT. Conclusions This study found that black and white patients with major depressive disorder had comparable outcomes. We also found that fewer black patients received ECT than whites, a difference that has been reported in other samples.

The association between skin color and 30-year cancer mortality in a random sample of black men and a peer-nominated group of high socioeconomic status (SES) black men was evaluated in the Charleston Heart Study, a prospective study, begun in 1960, designed to investigate the epidemiology of coronary heart disease in a biracial cohort. Skin color was used as a continuous variable and as a categorical variable, by tertiles, in a Cox proportional hazards regression model. In the high SES group, there was a statistically significant decreasing relationship between skin color and cancer mortality, with those having the lightest skin having the lowest cancer mortality. In the random sample of black men, the relationship between skin color and cancer mortality was not statistically significant; however, the data indicated a slight protective effect among those with the lightest skin color. Because degree of skin reflectance is a measure of black-white admixture, these results may indicate a genetic mechanism underlying the differences in cancer mortality across skin color groups. Skin color is also recognized as a marker for psychosocial factors. Therefore, poor prognosis among those with darker skin color as a result of failure of early detection, inadequate treatment, and a variety of psychosocial stressors represents an alternative explanation of the study findings.

There is limited research examining the treatment of atypical depression with electroconvulsive therapy (ECT). Early research1,2 suggested that ECT was ineffective in treating atypical depression. Although ECT resulted in minor improvement in mood,2 many patients with atypical depressive features did not maintain the effect. However, neither study categorically defined atypical depression. They regarded atypical as being different from typical depression on the basis of undefined or varying symptom feature differences. Also, the study of West and Dally2 was confounded by inclusion of patients who had primary anxiety disorders and secondary depression. While this early research has served as the basis for clinical decision making for decades, advances in both the understanding of atypical depression and the techniques involved in ECT recommend a reevaluation of this notion. Recently, the definition of atypical depression has been operationalized to include the presence of mood reactivity plus 13 or 24,5 of the following additional symptom(s): hypersomnia, increased appetite or weight gain, leaden paralysis, and interpersonal rejection sensitivity. More recent studies also suggest that atypical depression may be more prevalent than previously thought. Early rates of atypical depression varied between 1.4% and 2.8%,6,7 and a lifetime prevalence of 0.7% was found in the Epidemiologic Catchment Area study.8 However, a prevalence rate of 6% was found for atypical depression in the National Comorbidity Survey.9 Also, in the Sequenced Treatment Alternatives to Relieve Depression trial,10 18% of the first 1500 patients met criteria for depression with atypical features. Moreover, the practice of ECT has improved11–13 with standardized lead placement (e.g., bilateral, right unilateral) and improved stimulus dosing.14 Thus, it would be appropriate to reevaluate the clinical efficacy of ECT for the treatment of depression with atypical symptom features. This article describes and characterizes patients with atypical major depressive disorder referred for ECT in a multisite trial examining the efficacy of maintenance ECT and examines the outcome of acute-phase ECT for patients with and without atypical depressive symptom features.

SUMMARY We examined the interrelationships between gender, adverse psychiatric experiences, lifetime trauma, and PTSD among severely mentally ill patients via secondary analyses. Participants were 142 adult, psychiatric patients, randomly-selected from a public-sector setting. They completed self-report measures to assess for victimization during the course of their psychiatric care, lifetime victimization, and PTSD. There were a number of significant associations between psychiatric and lifetime victimization experiences among both men and women. However, victimization within the psychiatric setting was not significantly related to PTSD for either men or women. Replication and expansion of these findings is encouraged to promote safety in psychiatric settings.

Using secondary analyses from a randomized trial comparing the effectiveness of manualized cognitive-behavioral therapy for posttraumatic stress disorder, we compared ratings of therapist competency and adherence between two service delivery modes: telepsychiatry (TP) and same room (SR). Patients were 38 male treatment-seeking veterans recruited from a veterans affairs medical center. Domains of therapist competence and adherence included structuring sessions, implementing session activities, providing feedback, dealing with difficulties, developing rapport, and conveying empathy. Only one difference emerged between the two treatment conditions, with more favorable ratings on this item in the TP condition. Findings suggest that therapist competence and adherence to cognitive-behavioral therapy is similar whether the treatment is delivered via TP or by traditional means, and TP does not compromise therapists' ability to effectively structure sessions or build rapport with patients. These data further support the use of TP to address shortages in access to mental health care.

Objective To determine the relationship between baseline melancholic features with outcomes in patients with major depressive disorder referred for electroconvulsive therapy (ECT). Method In a multihospital (Consortium for Research in ECT) collaborative ECT study, SCID-1 interviews were obtained at study entry. Ratings of the 24-item Hamilton Rating Scale for Depression were obtained thrice weekly during the course of ECT, once during a subsequent treatment-free week, and periodically during 6-month continuation treatment with either bitemporal ECT or nortriptyline plus lithium (continuation pharmacotherapy). Results The evaluable sample was severely ill with a mean 24-item Hamilton Rating Scale for Depression score of 35.2 (+/-6.9). Of 489 patients, 63.6% (311) met DSM-IV criteria for melancholic features. During acute ECT, 62.1% of those with melancholic features remitted, as compared with 78.7% for those without melancholic features (P = 0.002). During medication continuation treatment (continuation pharmacotherapy), relapse rates were higher for those with melancholic features than for those without these features. Conversely, with continuation ECT, the rate of relapse was lower for those with, compared with those without, melancholic features. Conclusions Ascertaining melancholic features by SCID-1 criteria does not identify depressed patients more likely to respond to ECT as had been anticipated from the literature. Melancholic features were associated with poorer treatment outcomes in acute ECT. Those with melancholic features were less likely to relapse with continuation ECT, but those with melancholic features were more likely to relapse with continuation pharmacotherapy. The limitations of the DSM-IV criteria for melancholia are discussed.

The current study examined racial differences in the reported frequency and distress associated with potentially harmful or traumatic experiences occurring within psychiatric settings. One hundred and forty-two (109 African-American; 32 Caucasian) randomly selected adult consumers recruited from a community psychosocial day program completed a battery of self-report measures to assess experiences in the psychiatric setting, lifetime trauma exposure, PTSD severity, and were the subject of a chart review. A subset of participants (20%) also completed a qualitative interview exploring their perceptions of events occurring in psychiatric settings. Few racial differences were noted in the reported frequency or distress associated with particular events in the psychiatric setting. However, we found differential patterns of association between adverse psychiatric events and lifetime trauma history, and racial differences in diagnosis and medications prescribed by the mental health center. These racial differences merit further attention to better understand their meaning and to improve mental health services provided to both African-Americans and Caucasian public-sector psychiatric patients.

Multiple randomized controlled trials (RCTs) show that behavioral lifestyle interventions are effective in improving diabetes management and that comprehensive risk factor management improves cardiovascular disease (CVD) outcomes. The role of technology has been gaining strong support as evidence builds of its potential to improve diabetes management; however, evaluation of its impact in minority populations is limited. This study intends to provide early evidence of a theory-driven intervention, Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS), using real-time videoconferencing for education and skills training. We examine the potential for TABLETS to improve health risk behaviors and reduce CVD risk outcomes among a low-income African American (AA) population with poorly controlled type 2 diabetes. The study is a two-arm, pilot controlled trial that randomizes 30 participants to the TABLETS intervention and 30 participants to a usual care group. Blinded outcome assessments will be completed at baseline, 2.5 months (immediate post-intervention), and 6.5 months (follow-up). The TABLETS intervention consists of culturally tailored telephone-delivered diabetes education and skills training delivered via videoconferencing on tablet devices, with two booster sessions delivered via tablet-based videoconferencing at 3 months and 5 months to stimulate ongoing use of the tablet device with access to intervention materials via videoconferencing slides and a manual of supplementary materials. The primary outcomes are physical activity, diet, medication adherence, and self-monitoring behavior, whereas the secondary outcomes are HbA1c, low-density lipoprotein cholesterol (LDL-C), BP, CVD risk, and quality of life. This study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven, tablet-aided behavioral intervention that utilizes real-time videoconferencing technology for education and skills training on self-management behaviors and quality of life among a high-risk, low-income AA population with an uncontrolled dyad or triad of CVD risk factors (diabetes with or without hypertension or hyperlipidemia). The intervention leverages the use of novel technology for education and skill-building to foster improved diabetes self-management. The findings of this study will inform the process of disseminating the intervention to a broader and larger sample of people and can potentially be refined to align with clinical workflows that target a subsample of patients with poor diabetes self-management. The trial was registered in April 2014 with the United States National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier NCT02128854), available online at: http://clinicaltrials.gov/ct2/show/NCT02128854 .

To examine rates of medical and psychiatric disorders among 187 female veterans recruited at four Veterans Affairs Medical Centers (VAMCs), the recognition of such disorders by VAMC care providers, and the use of relevant medical and mental health services by women both within and outside of the VA setting.We used a cross-sectional, epidemiological design incorporating self-report measures, structured interviews, and chart reviews to obtain relevant information for analyses.Forty-four percent (43.9%) of women met criteria for at least one psychiatric disorder; 34.0% of these women met criteria for two or more additional psychiatric diagnoses, and concordance rates between interview and chart diagnoses were low. Ninety-five percent (95.2%) of women had a medical condition noted in their charts; 86.6% had two or more additional medical conditions, and a significant number of women had both medical and psychiatric diagnoses. Forty-four percent (43.9%) of women with an identified mental health condition received specialized mental health care by the VA in the past year.Findings from this study suggest that female veterans treated in VAMCs had significant medical and psychiatric problems, and these women might not be getting their health care needs adequately met through the VA health care system. In light of our findings, we discuss relevant implications and future directions for research.

Objective This study assessed the efficacy and safety of sertraline in the treatment of generalized anxiety disorder (GAD). Method The study was conducted from April 2000 to May 2002. Outpatients with DSM-IV GAD (N = 326) who satisfied inclusion/exclusion criteria and completed a 1-week screening phase were randomly assigned to 10-week double-blind treatment with flexible dosing of sertraline (50-200 mg/day) or placebo. The primary efficacy measure was change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score. Response was defined as a 50% or greater decrease in HAM-A total score at endpoint. Results Sertraline produced a statistically significant reduction in anxiety symptoms, as measured by HAM-A total change scores (p = .032), HAM-A psychic anxiety subscale (p = .011), and Hospital Anxiety and Depression Scale-anxiety subscale (p = .001). Response rates were significantly higher (p = .05) for the sertraline group (59.2%) compared to the placebo group (48.2%). Sertraline was well tolerated, with only sexual side effects reported significantly more often by subjects receiving sertraline than those receiving placebo. Conclusion Despite the relatively small between-group differences, study findings suggest a role for sertraline in the acute treatment of GAD.

Most studies of trends in antidepressant pharmacotherapy have focused on relatively mildly ill, nonpyschotic outpatients. In this report, we provide detailed information on psychotropic use among patients with unipolar depression participating in a large, multisite electroconculsive therapy (ECT) study. Adequacy of antidepressant medication trials was assessed with the Antidepressant Treatment History Form. Among patients with nonpsychotic depression, 27% (60/220) had not had an adequate trial of an antidepressant before ECT, and 63% (139/220) had had at least one inadequate trial. Surprisingly, 33% (79/243) of nonpsychotic patients had been prescribed an antipsychotic. Among patients with psychotic depression, 95% (101/106) had not been given an adequate combination of an antidepressant and antipsychotic agent, mostly due to low doses of the latter class. Among all patients in the trial, 61% (213/352) had been prescribed at least one benzodiazepine, and only 7% (24/352) had been given a lithium augmentation trial. Use of hypnotic agents and anticonvulsants was common. In conclusion, patients with severe depression referred for ECT with a unipolar depressive episode have high rates of psychotropic usage, much of which is inadequate.

To examine the prevalence and correlates of social anxiety disorder (SAD) in veterans, 733 veterans from four VA primary care clinics were evaluated using self-report questionnaires, telephone interviews, and a 12-month retrospective review of primary care charts. We also tested the concordance between primary care providers' detection of anxiety problems and diagnoses of SAD from psychiatric interviews. For the multi-site sample, 3.6% met criteria for SAD. A greater rate of SAD was found in veterans with than without post-traumatic stress disorder (PTSD) (22.0% vs. 1.1%), and primary care providers detected anxiety problems in only 58% of veterans with SAD. The elevated rate of comorbid psychiatric diagnoses and suicidal risk associated with SAD was not attributable to PTSD symptom severity. Moreover, even after controlling for the presence of major depressive disorder, SAD retained unique, adverse effects on PTSD diagnoses and severity, the presence of other psychiatric conditions, and suicidal risk. These results attest to strong relations between SAD and PTSD, the inadequate recognition of SAD in primary care settings, and the significant distress and impairment associated with SAD in veterans.

Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature. We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ≥8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group. Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM. This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658 ).

OBJECTIVE: This study examined the frequency and associated distress of potentially traumatic or harmful experiences occurring within psychiatric settings among persons with severe mental illness who were served by a public-sector mental health system. METHODS: Participants were 142 randomly selected adult psychiatric patients who were recruited through a day hospital program. Participants completed a battery of self-report measures to assess traumatic and harmful events that occurred during the course of their mental health care, lifetime trauma exposure, and symptoms of posttraumatic stress disorder. RESULTS: Data revealed high rates of reported lifetime trauma that occurred within psychiatric settings, including physical assault (31 percent), sexual assault (8 percent), and witnessing traumatic events (63 percent). The reported rates of potentially harmful experiences, such as being around frightening or violent patients (54 percent), were also high. Finally, reported rates of institutional measures of...