Longitudinal Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Pharmacotherapy in Major Depressive Disorder in Older Adults: Phase 2 of the PRIDE Study.

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.

Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Venlafaxine in Geriatric Depression: Phase 1 of the PRIDE Study.

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.

BEHAVIORAL ACTIVATION AND THERAPEUTIC EXPOSURE FOR POSTTRAUMATIC STRESS DISORDER: A NONINFERIORITY TRIAL OF TREATMENT DELIVERED IN PERSON VERSUS HOME-BASED TELEHEALTH.

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.

Depression severity in electroconvulsive therapy (ECT) versus pharmacotherapy trials.

OBJECTIVE: We sought to compare the level of severity of depressive symptoms on entry into electroconvulsive therapy (ECT) clinical trials versus pharmacotherapy clinical trials. DATA SOURCES: English-language MEDLINE/PubMed publication databases were searched for ECT literature (search terms: ECT, electroconvulsive therapy, depression, and Hamilton) for clinical trials in which depressed patients had baseline Hamilton Rating Scale for Depression (HRSD) scores. For comparison, we used a convenience sample of 7 large pharmacotherapy trials in major depression (N = 3677). The search included articles from 1960 to 2011. STUDY SELECTION: We included 100 studies that met the following criteria: ECT trial for depression, patients adequately characterized by diagnosis at baseline, and patients rated at baseline by 15-item HRSD (HRSD15), HRSD17, HRSD21, HRSD24, or HRSD28, with mean (SD) and sample size (n) reported. For the comparator pharmacotherapy trials, we chose to use a subset of the studies (excluding one study of minor depression) in the widely publicized meta-analysis of Fournier et al, as well as the STAR*D study and one additional study by Shelton et al. This provided 7 studies of major depression using HRSD17 (total N = 3677). DATA EXTRACTION: Data extracted included number of subjects and baseline and final HRSD scores, with mean (SD) values. RESULTS: Of 100 ECT studies, 56 studies (N = 2243) used the HRSD17 version. The mean baseline HRSD17 score in the ECT trials was 27.6, the mean in the pharmacotherapy trials was 21.94, a statistically, and clinically, significant difference. In a subanalysis of the 16 ECT studies that used the HRSD24 version, the mean baseline score was 32.2. CONCLUSIONS: This selective literature review confirms that patients who entered ECT clinical trials were more severely ill than those who entered the selected comparator pharmacotherapy trials. Such data highlight the critical role of ECT in the treatment of severe and treatment-resistant mood disorders.

Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol.

OBJECTIVE: This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented. METHODS: Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants. RESULTS: Study is ongoing and open to enrollment. CONCLUSION: The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

Factors associated with delays in seeking treatment for stroke care in veterans.

BACKGROUND: Our objective was to examine the association between delay in seeking treatment (DST) for stroke care and demographic and clinical characteristics variables in a sample of veterans. METHODS: We used survey data from 100 veterans with a diagnosis of stroke who were receiving poststroke care at a Veterans Affairs (VA) Medical Center in the southeastern United States to evaluate the relationship between DST and key sample demographic and clinical characteristics. We used backward stepwise logistic regression models to assess the independent association between DST and demographic and clinical variables. RESULTS: We found that stroke survivors reporting DST were more likely to be black (56.4% versus 32.8%; P = .02) and younger at the time of stroke onset (58.1 years versus 63.7 years; P = .02). In backward stepwise logistic regression models, being black was an independent predictor of DST (odds ratio [OR] 2.76; 95% confidence interval [CI], 1.04-7.30; P = .04) in this veteran population. CONCLUSIONS: Race appears to be a key factor associated with an increased likelihood of delays in seeking urgent stroke care in veterans. Future studies need to further examine the complex sociodemographic profile of patients who are most likely to delay seeking care for stroke and to develop interventions to reduce the impact of DST.

Randomized controlled trial of technology-assisted case management in low-income adults with type 2 diabetes: Effect on quality of life and blood pressure.

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.

HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes-study protocol for a randomized controlled trial.

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.gov NCT04203147 ). Registered on December 18, 2019, with the National Institutes of Health Clinical Trials Registry.

Evaluation of the Effects of Severe Depression on Global Cognitive Function and Memory.

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 (HRSD(24)). 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 HRSD(24) was 33.9 (SD=6.7). Mean demographic-corrected T-scores for each neurocognitive measure were in the average to borderline range, and HRSD(24) 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.

Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) - Study protocol for a randomized controlled trial.

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).

Toward individualized post-electroconvulsive therapy care: piloting the Symptom-Titrated, Algorithm-Based Longitudinal ECT (STABLE) intervention.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Effect of psychotherapy for depression via home telehealth on glycemic control in adults with type 2 diabetes: Subgroup analysis of a randomized clinical trial.

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.

Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial.

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 patients >60 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.

Effects of a Course of Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy Combined With Venlafaxine on Insomnia Symptoms in Elderly Depressed Patients.

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. METHODS: 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 in phase 1 of the National Institute of Mental Health-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 Depression Rating Scale-24 item (HDRS24), and measures of insomnia severity were extracted from the HDRS24. Participants were characterized at baseline as either "high-insomnia" or "low-insomnia" subtypes, based upon the sum of the 3 HDRS24 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 HDRS24 non-sleep items. Generalized linear models were used for longitudinal analysis of insomnia scores. RESULTS: Two hundred 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 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 HDRS non-insomnia items (HDRS-sleep) was accompanied by a "low" amount of improvement in insomnia scores (change of -1.6 ± 1.2, P < .0001), while a "high" amount of improvement on the sum of the HDRS non-insomnia items was accompanied by a "higher" amount of improvement in insomnia scores (change of -3.1 ± 1.6, P < .0001). After adjustment for non-insomnia symptoms, there was no change in insomnia in the low-insomnia group. CONCLUSIONS: We found that ECT, combined with venlafaxine, has a modest anti-insomnia effect that is linked to its antidepressant effect. Most patients will have some degree of residual insomnia after ECT, and will require some consideration of whether additional, targeted assessment and treatment of insomnia is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01028508.

Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE).

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.

Performance characteristics of the posttraumatic stress disorder checklist and SPAN in Veterans Affairs primary care settings.

BACKGROUND: Posttraumatic stress disorder (PTSD) is a treatable disorder, and individuals with this condition may benefit from early detection. Many people with PTSD are not aware of its symptoms and do not seek treatment, making a brief and targeted screening program a worthwhile endeavor. For this reason, research aimed at improving screening instruments could yield substantial benefits. OBJECTIVES: The primary objective of this research was to assess the diagnostic performance of two popular PTSD screening assessments, the PTSD Checklist (PCL) and the SPAN, in a Veterans Affairs (VA) primary care setting. Additionally, we compared the screening performance of these two assessments by sex and race. METHODS: The PCL and SPAN were compared with a gold standard, the Clinician-Administered PTSD Scale. Receiver operating characteristic curves were used in conjunction with sensitivity and specificity measures to assess the performance of each screening assessment. These analyses are based on a large database (n=1076) that was derived from a multisite cross-sectional study conducted at four southeastern VA medical centers. RESULTS: Results for the PCL support cutoff scores lower than those previously published, whereas results for the SPAN support the previously recommended cutoff score of 5 (sensitivity of 73.68% and specificity of 81.99%). We found no significant difference in areas under the curve (AUCs) by sex and by race between the PCL and SPAN. We did find that there was a highly significant difference (P<.0006) in overall diagnostic ability (as measured by the AUC) between the PCL (AUC=0.882) and SPAN (AUC=0.837), making the PCL the preferred screening tool, unless brevity is essential. CONCLUSIONS: Clinicians and researchers should consider lower cutoff scores for the PCL, but the originally suggested cutoff score for the SPAN is appropriate.

A randomized trial of telepsychiatry for post-traumatic stress disorder.

We compared the efficacy of telepsychiatry and same-room treatment of combat-related post-traumatic stress disorder (PTSD) using cognitive behavioural therapy in 14 weekly, 90-min treatment sessions. Of 97 patients referred for study participation, 38 were randomized (17 into telepsychiatry, 21 into same-room), and approximately 25 (the number differed by instrument) had at least one post-baseline assessment. Measures of clinical and process outcomes were examined. No group differences were found on clinical outcomes at three-month follow-up. Satisfaction with treatment ratings was similar in both groups, with 'strong satisfaction' indicated by veterans in both modalities. Attendance and drop-out were similar in the two groups. The same-room group reported more comfort in talking with their therapist at post-treatment and had better treatment adherence. The results provide preliminary support for the use of telepsychiatry in the treatment of PTSD to improve access to care.

Feasibility and Efficacy of Prolonged Exposure for PTSD among Individuals with a Psychotic Spectrum Disorder.

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. Conclusion: 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.

Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes.

OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.