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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.

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

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.

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: 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.

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.

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.

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.

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 .

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...

Objective The primary objective was to determine whether occupational exposure to organic solvents is related to an increased risk of systemic sclerosis (SSc; scleroderma). Methods Occupational histories were obtained from 178 SSc patients and 200 controls. Exposure scores were computed for each individual using job exposure matrices, which were validated by an industrial expert. Results Among men, those with SSc were more likely than controls to have a high cumulative intensity score (odds ratio [OR] 2.9, 95% confidence interval [95% CI] 1.1-7.6) and a high maximum intensity score (OR 2.9, 95% CI 1.2-7.1) for any solvent exposure. They were also more likely than controls to have a high maximum intensity score for trichloroethylene exposure (OR 3.3, 95% CI 1.0-10.3). Among men and women, significant solvent-disease associations were observed among SSc patients who tested positive for the anti-Scl-70 autoantibody; these trends were not observed among the men and women who tested negative for anti-Scl-70. Conclusion These results provide evidence that occupational solvent exposure may be associated with an increased risk of SSc.

Background An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offer new opportunities to support patients with T2DM while waiting to be seen by their health care providers at actual office visits. A variety of interventions testing the efficacy of telemedicine interventions have been conducted, but the outcomes have yielded equivocal results, emphasizing the shortage of controlled, randomized trials in this area. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina. Methods We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200) male and female participants, 18 years of age or older and with an HbA1c ≥ 8%, will be randomized into one of two groups: (1) an intervention arm employing the innovative FORA system coupled with nurse case management or (2) a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care. Discussion Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM) for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's. Trial Registration National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489

BACKGROUND The long-term predictive significance of a single ECG tracing for mortality was explored among the white and black men of the Charleston Heart Study. METHODS AND RESULTS The 1960 baseline tracings of men ages 35 to 74 in the Charleston Heart Study cohort were coded according to the Minnesota classification. Tracings were categorized as being normal or having minor or major abnormalities. The 30-year vital status was ascertained for the cohort, and the association between ECG findings and coronary and all-cause mortality was evaluated. The proportion of black men with major abnormalities at the 1960 baseline examination was almost twice that of white men. Rates of all-cause mortality increased with severity of abnormalities for white and black men. The absolute excess risk for black men with major abnormalities was 23.3 per 1000 person-years and 12.8 for white men. The excess risk for coronary mortality was 7.3 for white men and 6.5 for black men. CONCLUSIONS Many of the findings in this study confirm earlier associations derived from studies of white populations and extend the observations to black men. However, the magnitude of the relative risk for mortality was different for white and black men. After controlling for traditional coronary disease risk factors and minor abnormalities, white men with major abnormalities were 2.72 (95% confidence interval, 1.47, 5.04) times more likely to die of coronary disease compared with black men, who were 1.95 (95% confidence interval, 0.93, 4.11) times more likely to die of coronary disease.

Introduction: Major depressive disorder (MDD) is thought to negatively impact cognitive function; however, the relationship has not been well explored.Objective: This study examined the association between depression severity and global cognitive function and memory in subjects with severe, treatment-resistant MDD.Methods: We enrolled 66 subjects with Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosed unipolar MDD in a multicenter trial to assess the efficacy and neurocognitive effects of electroconvulsive therapy (ECT). We measured depression severity with the 24 item Hamilton Rating Scale for Depression (HRSD24). Neuropsychologic measures included the Mini Mental State Examination (MMSE), Rey Auditory Verbal Learning Test (RAVLT), and the Complex Figure Test (CFT). Correlational and regression analyses were conducted to explore associations between depression severity and cognitive function.Results: The mean age of the subjects was 53.6 years (SD=15.8), 65% were female, and mean HRSD24 was 33.9 (SD=6.7). Mean demographic-corrected T-scores for each neurocognitive measure were in the average to borderline range, and HRSD24 values were unrelated to performance on the MMSE, RAVLT immediate and delayed recall, and CFT immediate and delayed recall.Conclusion: In this sample of severely depressed subjects referred for ECT, depression severity was unrelated to global cognitive function or memory. Future research should examine the interactions between other depressive characteristics and neurocognitive function.

BackgroundElectroconvulsive therapy (ECT) is an effective treatment for major depression. Optimising efficacy and minimising cognitive impairment are goals of ongoing technical refinements.AimsTo compare the efficacy and cognitive effects of a novel electrode placement, bifrontal, with two standard electrode placements, bitemporal and right unilateral in ECT.MethodThis multicentre randomised, double-blind, controlled trial (NCT00069407) was carried out from 2001 to 2006. A total of 230 individuals with major depression, bipolar and unipolar, were randomly assigned to one of three electrode placements during a course of ECT: bifrontal at one and a half times seizure threshold, bitemporal at one and a half times seizure threshold and right unilateral at six times seizure threshold.ResultsAll three electrode placements resulted in both clinically and statistically significant antidepressant outcomes. Remission rates were 55% (95% CI 43–66%) with right unilateral, 61% with bifrontal (95% CI 50–71%) and 64% (95% CI 53–75%) with bitemporal. Bitemporal resulted in a more rapid decline in symptom ratings over the early course of treatment. Cognitive data revealed few differences between the electrode placements on a variety of neuropsychological instruments.ConclusionsEach electrode placement is a very effective antidepressant treatment when given with appropriate electrical dosing. Bitemporal leads to more rapid symptom reduction and should be considered the preferred placement for urgent clinical situations. The cognitive profile of bifrontal is not substantially different from that of bitemporal.

This study examined therapists’ fidelity to a manualized multi-component cognitive-behavioral intervention for posttraumatic stress disorder (PTSD), including exposure therapy, among public sector patients with a psychotic disorder. Therapists’ competence and adherence was assessed by clinicians at the master’s level or higher who rated 20% of randomly selected audiotaped sessions (n = 57 sessions, coded by two independent raters, with strong interrater agreement). Adherence ratings indicated that therapists complied well with the protocol, and competency ratings typically averaged above “very good” (6 on 7-point Likert scale). Findings suggest that therapists can effectively deliver a manualized cognitive-behavioral intervention for PTSD, with exposure therapy, to patients with severe mental illness without compromise to the structure of sessions and/or to the therapeutic relationship. These data add needed support for the implementation of cognitive-behavioral interventions, including exposure therapy, as effective treatments for PTSD in complicated patient populations such as those with severe forms of mental illness.

In an open trial design, adults (n = 20) with posttraumatic stress disorder (PTSD) and either schizophrenia or schizoaffective disorder were treated via an 11-week cognitive-behavioral intervention for PTSD that consisted of education, anxiety management therapy, social skills training, and exposure therapy, provided at community mental health centers. Results offer preliminary hope for effective treatment of PTSD among adults with schizophrenia or schizoaffective disorder, especially among treatment completers (n = 13). Data showed significant PTSD symptom improvement, maintained at 3-month follow-up. Further, 12 of 13 completers no longer met criteria for PTSD or were considered treatment responders. Clinical outcomes for other targeted domains (e.g., anger, general mental health) also improved and were maintained at 3-month follow-up. Participants evidenced high treatment satisfaction, with no adverse events. Significant improvements were not noted on depression, general anxiety, or physical health status. Future directions include the need for randomized controlled trials and dissemination efforts.

We appreciate the important contribution of Spaans et al [1][1] to the evidence that electroconvulsive therapy (ECT) is a rapidly acting treatment in geriatric depression. Their data are a reminder that, despite the recent excitement about other neuromodulation modalities for the treatment of

Background Although electroconvulsive therapy (ECT) has been shown to be extremely effective for the acute treatment of major depression, it has never been systematically assessed as a strategy for relapse prevention. Objective To evaluate the comparative efficacy of continuation ECT (C-ECT) and the combination of lithium carbonate plus nortriptyline hydrochloride (C-Pharm) in the prevention of depressive relapse. Design Multisite, randomized, parallel design, 6-month trial performed from 1997 to 2004. Setting Five academic medical centers and their outpatient psychiatry clinics. Patients Two hundred one patients with Structured Clinical Interview for DSM-IV– diagnosed unipolar depression who had remitted with a course of bilateral ECT. Interventions Random assignment to 2 treatment groups receiving either C-ECT (10 treatments) or C-Pharm for 6 months. Main Outcome Measure Relapse of depression, compared between the C-ECT and C-Pharm groups. Results In the C-ECT group, 37.1% experienced disease relapse, 46.1% continued to have disease remission at the study end, and 16.8% dropped out of the study. In the C-Pharm group, 31.6% experienced disease relapse, 46.3% continued to have disease remission, and 22.1% dropped out of the study. Both Kaplan-Meier and Cox proportional hazards regression analyses indicated no statistically significant differences in overall survival curves and time to relapse for the groups. Mean ± SD time to relapse for the C-ECT group was 9.1 ± 7.0 weeks compared with 6.7 ± 4.6 weeks for the C-Pharm group ( P = .13). Both groups had relapse proportions significantly lower than a historical placebo control from a similarly designed study. Conclusions Both C-ECT and C-Pharm were shown to be superior to a historical placebo control, but both had limited efficacy, with more than half of patients either experiencing disease relapse or dropping out of the study. Even more effective strategies for relapse prevention in mood disorders are urgently needed.

This study assessed the incidence, severity, and course of expressed suicidal intent in depressed patients who were treated with ECT. The data are from the first phase of an ongoing, collaborative multicenter study, the overall aim of which was to compare continuation ECT with pharmacotherapy in the prevention of relapse after a successful course of ECT.Suicidal intent, as expressed by patients during an interview, was scored at baseline and before each ECT session with item 3 on the 24-item Hamilton Depression Rating Scale in 444 patients with unipolar depression.One hundred thirty-one patients (29.5%) reported suicidal thoughts and acts (score of 3 or 4) at baseline. Scores decreased to 0 after 1 week (three ECT sessions) in 38.2% of the patients, after 2 weeks (six ECT sessions) in 61.1%, and in 80.9% at the end of the course of treatment.Expressed suicidal intent in depressed patients was rapidly relieved with ECT. Evidence-based treatment algorithms for major depressive mood disorders should include dichotomization according to suicide risk, as assessed by interview. For patients at risk, ECT should be considered earlier than at its conventional "last resort" position.

Background Approximately 30% of intubated preterm infants with respiratory distress syndrome (RDS) will fail attempted extubation, requiring reintubation and mechanical ventilation. Although ventilator technology and monitoring of premature infants have improved over time, optimal extubation remains challenging. Furthermore, extubation decisions for premature infants require complex informational processing, techniques implicitly learned through clinical practice. Computer-aided decision-support tools would benefit inexperienced clinicians, especially during peak neonatal intensive care unit (NICU) census. Methods A five-step procedure was developed to identify predictive variables. Clinical expert (CE) thought processes comprised one model. Variables from that model were used to develop two mathematical models for the decision-support tool: an artificial neural network (ANN) and a multivariate logistic regression model (MLR). The ranking of the variables in the three models was compared using the Wilcoxon Signed Rank Test. The best performing model was used in a web-based decision-support tool with a user interface implemented in Hypertext Markup Language (HTML) and the mathematical model employing the ANN. Results CEs identified 51 potentially predictive variables for extubation decisions for an infant on mechanical ventilation. Comparisons of the three models showed a significant difference between the ANN and the CE (p = 0.0006). Of the original 51 potentially predictive variables, the 13 most predictive variables were used to develop an ANN as a web-based decision-tool. The ANN processes user-provided data and returns the prediction 0–1 score and a novelty index. The user then selects the most appropriate threshold for categorizing the prediction as a success or failure. Furthermore, the novelty index, indicating the similarity of the test case to the training case, allows the user to assess the confidence level of the prediction with regard to how much the new data differ from the data originally used for the development of the prediction tool. Conclusion State-of-the-art, machine-learning methods can be employed for the development of sophisticated tools to aid clinicians' decisions. We identified numerous variables considered relevant for extubation decisions for mechanically ventilated premature infants with RDS. We then developed a web-based decision-support tool for clinicians which can be made widely available and potentially improve patient care world wide.

The web-based implementation of a decision-support tool for the prediction of extubation outcome in mechanically ventilated premature infants enables the integration of advanced and computationally intensive modeling approaches with easy-usage, no maintenance requirements and wide availability. Accordingly, the artificial neural network predictive tool developed provides decision-support in determining whether to extubate a premature infant to clinicians in NICUs anywhere with access to the Internet.

Objective In response to new developments and interest in the area of telepsychiatry, literature on this topic has greatly increased over the past three years. Because of this increase, the authors conducted a literature review of telepsychiatry to update a previously published review that covered the years 1970 to 2000. Methods A search was conducted on the MEDLINE, PsycINFO, and Telemedicine Information Exchange (TIE) databases for literature published from March 2000 to March 2003 on telepsychiatry applications, using the following terms: telepsychiatry, telepsychology, telemental health, videoconferencing, and video conferencing. Results Sixty-eight publications were identified over this three-year period, exceeding the 63 publications identified in the previous literature review. The authors summarize the results of findings in six areas: novel clinical demonstrations and current program descriptions; the reliability of clinical assessments; clinical outcomes; satisfaction of patients and clinicians; cost and cost-effectiveness; and legal, regulatory, and ethical issues. Studies describing existing programs and novel clinical applications support the belief that the use of telepsychiatry is expanding. Overall, studies continued to support the notion that telepsychiatry assessments can produce reliable results, telepsychiatric services can lead to improved clinical status, and patients and clinicians are satisfied with treatment delivered via telepsychiatry. Evidence supported the notion that telepsychiatry is a cost-effective means of delivering mental health services; however, this conclusion was based on limited studies of economic models of telepsychiatry programs. Also limited were papers on the topics of legal, regulatory, and ethical issues. Conclusions Despite the rapid increase in information on telepsychiatry, methodologically sound studies in the area of telepsychiatry are still infrequent.

Knapp RG, Schreiner PJ, Sutherland SE, Keil JE, Gilbert GE, Klein RL, Hames C, Tyroler HA. Serum lipoprotein(a) levels in elderly black and white men in the Charleston Heart Study. Clin Genet 1993: 44: 225–231. © Munksgaard, 1993 Lipoprotein(a) [Lp(a)] is an important genetic trait associated with cardiovascular disease. While Lp(a) levels have been demonstrated to be approximately twice as high in black adults and children compared with whites, this relationship has not been assessed in the elderly. During the 1987 recall of the Charleston Heart Study cohort, plasma Lp(a) [mg\dl] was measured on 113 white men and 83 black men. The average age of those having Lp(a) measurements was 71 years (\pm6) for white men and 72 years (\pm 9) for black men. The distribution of Lp(a) was skewed in both whites = (mean = 14.8, median = 8.2 mg\dl) and blacks (mean = 18.1, median = 12.8 mg/dl). The skewed distribution in elderly black men was in contrast to the bell-shaped distribution commonly reported for younger blacks. The Charleston Heart Study data suggest a shift to lower values among elderly as compared to younger men, with the greatest shift occurring among the black men. For black men who have survived to the 7th, 8th, and 9th decades of life, Lp(a) levels appear to be approaching the lower levels of white men. Despite this shift in distribution among black men, there remained a statistically significant difference in Lp(a) between racial groups.

Although concerns have been expressed that mortality from coronary disease and all other causes is greater among Blacks than Whites, we hypothesized that, when socioeconomic status is adequately considered, mortality inequalities between Blacks and Whites are insignificant. The study population was a random sampling of Black and White men who were 35 years of age or older when recruited into the Charleston Heart Study in 1960. Education level and occupational status at baseline were used to compare mortality over the ensuing 28 years between Black and White men, who were classified as low or high socioeconomic status. In no instance were Black-White differences in all-cause or coronary disease mortality rates significantly different when socioeconomic status was controlled. We conclude that socioeconomic status is an important predictor of mortality and that, when socioeconomic status is considered, differences in Black-White mortality rates may be small.

A model describes the joint distribution of paired survival times based on certain reasonable assumptions appropriate for biological data generated in a clinical trial setting or for certain failure data. An exact parametric test for equality of mean survival times for data following this distribution is developed. The power of the exact test is investigated by a computer simulation study for various sample sizes and values of the model parameters and compared to that of alternative tests. Heretofore, researchers desiring to analyze paired survival data have resorted to paired t tests or nonparametric procedures such as the sign test or signed ranks test. The t-test is invalid for non-normally distributed data although the robustness of the test might minimize the difficulty. The nonparametric tests, by their nature, fail to use the data completely. This paper presents an exact parametric test based on a distribution whose justification requires rather modest and reasonable assumptions. Critical values for the test can be obtained from a table of the chi-square distribution. This exact test appears to be a viable alternative to non-parametric approaches to the analysis of paired survival data. It is extremely easy to calculate on a hand calculator. In fact, since no data storage is required (unlike the signed ranks test), the calculations can be readily programmed on a programmable calculator. The modeling of bivariate and multivariate survival data we believe has not been adequately addressed in the statistical and engineering literature. We hope that this paper will spark additional work.

Background Older adults who live in rural areas experience significant disparities in health status and access to mental health care. "Telepsychology," (also referred to as "telepsychiatry," or "telemental health") represents a potential strategy towards addressing this longstanding problem. Older adults may benefit from telepsychology due to its: (1) utility to address existing problematic access to care for rural residents; (2) capacity to reduce stigma associated with traditional mental health care; and (3) utility to overcome significant age-related problems in ambulation and transportation. Moreover, preliminary evidence indicates that telepsychiatry programs are often less expensive for patients, and reduce travel time, travel costs, and time off from work. Thus, telepsychology may provide a cost-efficient solution to access-to-care problems in rural areas. Methods We describe an ongoing four-year prospective, randomized clinical trial comparing the effectiveness of an empirically supported treatment for major depressive disorder, Behavioral Activation, delivered either via in-home videoconferencing technology ("Telepsychology") or traditional face-to-face services ("Same-Room"). Our hypothesis is that in-homeTelepsychology service delivery will be equally effective as the traditional mode (Same-Room). Two-hundred twenty-four (224) male and female elderly participants will be administered protocol-driven individual Behavioral Activation therapy for depression over an 8-week period; and subjects will be followed for 12-months to ascertain longer-term effects of the treatment on three outcomes domains: (1) clinical outcomes (symptom severity, social functioning); (2) process variables (patient satisfaction, treatment credibility, attendance, adherence, dropout); and (3) economic outcomes (cost and resource use). Discussion Results from the proposed study will provide important insight into whether telepsychology service delivery is as effective as the traditional mode of service delivery, defined in terms of clinical, process, and economic outcomes, for elderly patients with depression residing in rural areas without adequate access to mental health services. Trial registration National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT00324701).