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Strategies are needed to ensure greater participation of underrepresented groups in diabetes research. We examined the impact of a remote study protocol on enrollment in diabetes research, specifically the Pre-NDPP clinical trial. Recruitment was conducted among 2807 diverse patients in a safety-net healthcare system. Results indicated three-fold greater odds of enrolling in remote versus in-person protocols (AOR 2.90; P < 0.001 [95% CI 2.29-3.67]). Priority populations with significantly higher enrollment included Latinx and Black individuals, Spanish speakers, and individuals who had Medicaid or were uninsured. A remote study design may promote overall recruitment into clinical trials, while effectively supporting enrollment of underrepresented groups., Competing Interests: The authors report no conflicts of interest., (© The Author(s) 2024.)

This is an introduction to the special issue "Vaccine Hesitancy and Refusal." This special issue of Health Psychology examines various aspects of vaccine hesitancy using a health psychology lens. The timing of this issue, following a call for papers issued in the summer of 2021, in the midst of the COVID-19 pandemic, is reflected in the focus on COVID-19 vaccine hesitancy in the papers included here. This is important, as the field of vaccine hesitancy research has expanded greatly in response to the COVID-19 pandemic. As of March 2, 2023, a search of PubMed for "vaccine hesitancy" yielded 5,635 papers, dating back to 1968. A similar search for "COVID vaccine hesitancy" yielded 3,851 papers, starting in 2020. This highlights the need for new and novel theory-based interventions that can be broadly applicable to hesitancy to other routine vaccinations. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Healthcare workers (HCWs) experienced significantly higher burdens and life demands due to the COVID-19 pandemic. This study sought to assess the longitudinal effects among HCWs throughout the pandemic. Qualtrics surveys collected self-reported data on weight changes, eating patterns, physical activity (PA), and psychological factors with data organized by timepoints prior to the pandemic (PP0—prior to March 2020), baseline (M0—January 2021), month 6 (M6—July 2021), and month 12 (M12—January 2022). Eating patterns were negatively impacted at the M0, with reported increases in snacking/grazing (69.7%), fast food/take-out consumption (57.8%), and alcohol (48.8%). However, by M6 and M12 there were no statistically significant differences in eating patterns, suggesting that eating patterns normalized over time. Mean weight increased from PP0 to M0 by 2.99 pounds (p < 0.001, n = 226) and from PP0 to M6 by 2.12 pounds (p < 0.027, n = 146), though the difference in mean weight from PP0 to M12 was not statistically significant (n = 122). PA counts decreased from 8.00 sessions per week PP0 to 6.80 by M0 (p = 0.005) before jumping to 12.00 at M6 (p < 0.001) and 10.67 at M12 (p < 0.001). Psychological factors comparing M0 to M12 found statistically significant differences for depression (p-value = 0.018) and anxiety (p-value = 0.001), meaning depression and anxiety were initially increased but improved by M12. Additionally, higher scores on depression and insomnia scales were associated with lower PA levels. These overall results imply that the COVID-19 pandemic had immediate effects on the eating patterns, weight changes, PA, and psychological factors of HCWs; however, routines and lifestyle habits appeared to have normalized one year later.

To explore whether case-based learning will enhance a weight bias reduction (WBR) programme among nursing students to improve their attitudes and beliefs towards persons with obesity. A cluster-randomized controlled trial (CRT) among 13 medical-surgical clinical practicum groups consisting of six to eight third-year baccalaureate nursing students was conducted to compare a WBR training enhanced by case-based learning (WBR-I, n = 7) with a standard WBR control group (n = 6). All participants completed the Attitudes Towards Obese Persons (ATOP) and Beliefs About Obese Persons (BAOP) questionnaires before the randomized assignment and at the end of the 14-week semester. The BAOP scores of participants in the WBR-I group were significantly improved compared to controls (26.68 ± 7.85 and 22.93 ± 2.80, respectively; F = 18.23; p = .001 (<.01) indicating improved beliefs about the controllability of obesity. There were no significant changes to attitudes about individuals with obesity, as indicated by the ATOP scores. The findings of this pilot study suggest that a more intensive WBR programme that includes case-based learning scenarios that elicit critical thinking coupled with a standard WBR programme may reduce some aspects of weight bias., (© 2021 World Obesity Federation.)

Objective: Cardiac ischemia during daily life is associated with an increased risk of adverse outcomes. Mental stress is known to provoke cardiac ischemia and is related to psychological variables. In this multicenter cohort study, we assessed whether psychological characteristics were associated with ischemia in daily life., Methods: This study examined patients with clinically stable coronary artery disease (CAD) with documented cardiac ischemia during treadmill exercise (n = 196, mean [standard deviation] age = 62.64 [8.31] years; 13% women). Daily life ischemia (DLI) was assessed by 48-hour ambulatory electrocardiophic monitoring. Psychological characteristics were assessed using validated instruments to identify characteristics associated with ischemia occurring in daily life stress., Results: High scores on anger and hostility were common in this sample of patients with CAD, and DLI was documented in 83 (42%) patients. However, the presence of DLI was associated with lower anger scores (odds ratio [OR] = 2.03; 95% confidence interval [CI] = 1.12-3.69), reduced anger expressiveness (OR = 2.04; 95% CI = 1.10-3.75), and increased ratio of anger control to total anger (OR = 2.33; 95% CI = 1.27-4.17). Increased risk of DLI was also associated with lower hostile attribution (OR = 2.22; 95% CI = 1.21-4.09), hostile affect (OR = 1.92; 95% CI = 1.03-3.58), and aggressive responding (OR = 2.26; 95% CI = 1.25-4.08). We observed weak inverse correlations between DLI episode frequency and anger expressiveness, total anger, and hostility scores. DLI was not associated with depression or anxiety measures. The combination of the constructs low anger expressiveness and low hostile attribution was independently associated with DLI (OR = = 2.59; 95% CI = 1.42-4.72)., Conclusions: In clinically stable patients with CAD, the tendency to suppress angry and hostile feelings, particularly openly aggressive behavior, was associated with DLI. These findings warrant a study in larger cohorts, and intervention studies are needed to ascertain whether management strategies that modify these psychological characteristics improve outcomes., (Copyright © 2022 by the American Psychosomatic Society.)

Objective: Difficulty achieving preset goals (e.g., ≥5% weight loss, ≥150 min of weekly physical activity) in the yearlong National Diabetes Prevention Program (NDPP) can prompt dropout and diminish benefits. We piloted a more patient-centered NDPP adaptation (NDPP-Flex) that promotes a variety of attainable and individually tailored goals to reduce diabetes risks, along with flexibility to adjust goals each week as needed., Research Design and Methods: Retention, physical activity, weight, and glycated hemoglobin (HbA 1c ) were evaluated among diverse participants with diabetes risks who received our pilot of NDPP-Flex beginning in January and July 2018 ( n = 95), with a planned comparison with standard NDPP delivery in preceding cohorts that launched between September 2016 and October 2017 ( n = 245). Both the standard NDPP and NDPP-Flex interventions were 1 year in duration and implemented in phases (i.e., nonrandomized)., Results: Average adjusted retention (e.g., 158.90 ± 15.20 vs. 166.71 ± 9.38 days; P = 0.674), physical activity (157.97 ± 11.91 vs. 175.64 ± 7.54 weekly min; P = 0.231), and weight loss (1.46 ± 0.38% vs. 1.90 ± 0.24%; P = 0.396) were similar between NDPP-Flex versus standard NDPP. However, NDPP-Flex participants had greater HbA 1c reduction on average (0.22 ± 0.05% vs. 0.06 ± 0.03%; P = 0.018) and were more likely to have normoglycemia at follow-up (odds ratio 4.62; P = 0.013 [95% CI 1.38-15.50]) than participants in the standard NDPP., Conclusions: An adapted, more patient-centered NDPP that focuses on flexible, self-selected goals may be a promising strategy to improve glycemia even in the absence of substantial weight loss., (© 2021 by the American Diabetes Association.)

Background: Early in the development of the COVID-19 pandemic, it was evident that health care workers, first responders, and other essential workers would face significant stress and workplace demands related to equipment shortages and rapidly growing infections in the general population. Although the effects of other sources of stress on health have been documented, the effects of these unique conditions of the COVID-19 pandemic on the long-term health and well-being of the health care workforce are not known., Objective: The COVID-19 Study of Healthcare and Support Personnel (CHAMPS) was designed to document early and longitudinal effects of the pandemic on the mental and physical health of essential workers engaged in health care. We will investigate mediators and moderators of these effects and evaluate the influence of exposure to stress, including morbidity and mortality, over time. We will also examine the effect of protective factors and resilience on health outcomes., Methods: The study cohort is a convenience sample recruited nationally through communities, professional organizations, networks, social media, and snowball sampling. Recruitment took place for 13 months to obtain an estimated sample of 2762 adults who provided self-reported information administered on the web through structured questionnaires about their work environment, mental and physical health, and psychosocial factors. Follow-up questionnaires will be administered after 6 months and annually thereafter to ascertain changes in health, well-being, and lifestyle. Participants who consented to be recontacted form the longitudinal cohort and the CHAMPS Registry may be contacted to ascertain their interest in ancillary studies for which they may be eligible., Results: The study was approved by the Institutional Review Board and launched in May 2020, with grants from Travere Therapeutics Inc, McKesson Corporation, anonymous donors, and internal funding from the M. Louise Fitzpatrick College of Nursing at Villanova University. Recruitment ended in June 2021 after enrolling 2762 participants, 1534 of whom agreed to participate in the longitudinal study and the registry as well as to be contacted about eligibility for future studies., Conclusions: The CHAMPS Study and Registry will enable the acquisition of detailed data on the effects of extended psychosocial and workplace stress on morbidity and mortality and serve as a platform for ancillary studies related to the COVID-19 pandemic., Trial Registration: ClinicalTrials.gov NCT04370821; https://clinicaltrials.gov/ct2/show/NCT04370821., International Registered Report Identifier (irrid): DERR1-10.2196/30757., (©Peter G Kaufmann, Donna S Havens, Janell L Mensinger, Patricia K Bradley, Heather M Brom, Linda C Copel, Alexander Costello, Christine D'Annunzio, Jennifer Dean Durning, Linda Maldonado, Ann Barrow McKenzie, Suzanne C Smeltzer, Jennifer Yost, CHAMPS Study Investigators. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.10.2021.)

Background: Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov., Objective: This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment., Methods: This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery., Results: This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024., Conclusions: This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country., Trial Registration: ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499., International Registered Report Identifier (irrid): PRR1-10.2196/15499., (©Natalie D Ritchie, Jodi Summers Holtrop, R Mark Gritz, Katherine Ann Sauder, Michael Josh Durfee, L Miriam Dickinson, Peter G Kaufmann. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.06.2020.)

Purpose: The National Diabetes Prevention Program (NDPP) is a widely disseminated lifestyle intervention. Attendance is problematic, leading to suboptimal weight loss, especially among racial/ethnic minority participants. We conducted a novel "presession" protocol to improve engagement of diverse NDPP candidates, comparing NDPP participants who attended a presession to those who did not on attendance and weight loss outcomes., Design: Longitudinal cohort study., Setting: A safety net health-care system., Participants: A total of 1140 patients with diabetes risks (58.9% Hispanic, 19.8% non-Hispanic black, 61.8% low income)., Intervention: The NDPP has been delivered in a Denver, Colorado health-care system since 2013. The program included 22 to 25 sessions over 1 year. Beginning September 2016, individuals were required to attend a presession before enrollment that focused on (1) increasing risk awareness, (2) motivational interviewing to participate in the NDPP, and (3) problem-solving around engagement barriers., Measures: Duration and intensity of NDPP attendance and weight loss., Analysis: Outcomes of 75 presession participants who enrolled in the NDPP were compared to 1065 prior participants using analysis of covariance and multivariable logistic regression., Results: Presession participants stayed in the NDPP 99.8 days longer ( P < .001) and attended 14.3% more sessions ( P < .001) on average than those without a presession. Presession participants lost 2.0% more weight ( P < .001) and were 3.5 times more likely to achieve the 5% weight loss target ( P < .001)., Conclusion: Presessions may improve NDPP outcomes for individuals from diverse backgrounds. A full-scale trial is needed to determine whether presessions reliably improve NDPP effectiveness.

Although deaths due to cardiovascular diseases have declined significantly since the 1970s, they remain the most common cause of morbidity and mortality in the United States. A large number of cardiovascular risk factors, such as smoking, obesity, and sedentary lifestyle, are modifiable. Psychologists and other behavioral scientists and practitioners are engaged in not only understanding the mechanistic links between behaviors and cardiovascular health but also developing effective interventions for improving health. The purpose of this special issue is to highlight some of the more innovative psychological research in cardiovascular health promotion, disease prevention, and management. Articles included in this issue focus on 2 primary areas. First, cutting-edge research on the current state of knowledge of modifiable health behaviors and their impact on cardiovascular health include articles on e-cigarette use as a putative risk factor, psychological factors involved in adherence to medications, the role of sleep in cardiovascular health, and innovative approaches to enhancing the treatment and recovery of patients with cardiovascular diseases. Second, outstanding research identifying the mechanisms by which psychological factors such as stress, depression, and anxiety impact cardiovascular disease include an overview of the current state of science examining psychological comorbidities that can accompany cardiovascular disease and influence outcomes, discussion of the neurocognitive processes that connect stress appraisal with biological functioning and diseases processes, and the role of genetics on behavioral interventions and clinical decision-making in the context of behavioral weight loss treatments. Our goal with these innovative articles is to stimulate additional advances in cardiovascular behavioral medicine. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

If the control of infectious diseases was the public health success story of the first half of the 20th century, then the decline in mortality from coronary heart disease and stroke has been the success story of the century's past 4 decades. The early phase of this decline in coronary heart disease and stroke was unexpected and controversial when first reported in the mid-1970s, having followed 60 years of gradual increase as the US population aged. However, in 1978, the participants in a conference convened by the National Heart, Lung, and Blood Institute concluded that a significant recent downtick in coronary heart disease and stroke mortality rates had definitely occurred, at least in the US Since 1978, a sharp decline in mortality rates from coronary heart disease and stroke has become unmistakable throughout the industrialized world, with age-adjusted mortality rates having declined to about one third of their 1960s baseline by 2000. Models have shown that this remarkable decline has been fueled by rapid progress in both prevention and treatment, including precipitous declines in cigarette smoking, improvements in hypertension treatment and control, widespread use of statins to lower circulating cholesterol levels, and the development and timely use of thrombolysis and stents in acute coronary syndrome to limit or prevent infarction. However, despite the huge growth in knowledge and advances in prevention and treatment, there remain many questions about this decline. In fact, there is evidence that the rate of decline may have abated and may even be showing early signs of reversal in some population groups. The National Heart, Lung, and Blood Institute, through a request for information, is soliciting input that could inform a follow-up conference on or near the 40th anniversary of the original landmark conference to further explore these trends in cardiovascular mortality in the context of what has come before and what may lie ahead., Competing Interests: Disclosure None, (© 2017 American Heart Association, Inc.)

Achieving health equity requires that every person has the opportunity to attain their full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances. Inequity experienced by populations of lower socioeconomic status is reflected in differences in health status and mortality rates, as well as in the distribution of disease, disability and illness across these population groups. This article gives an overview of the health inequities literature associated with heart, lung, blood and sleep (HLBS) disorders. We present an ecological framework that provides a theoretical foundation to study late-stage T4 translation research that studies implementation strategies for proven effective interventions to address health inequities.

The Centers for Population Health and Health Disparities program promotes multilevel and multifactorial health equity research and the building of research teams that are transdisciplinary. We summarized 5 areas of scientific training for empowering the next generation of health disparities investigators with research methods and skills that are needed to solve disparities and inequalities in cancer and cardiovascular disease. These areas include social epidemiology, multilevel modeling, health care systems or health care delivery, community-based participatory research, and implementation science. We reviewed the acquisition of the skill sets described in the training components; these skill sets will position trainees to become leaders capable of effecting significant change because they provide tools that can be used to address the complexities of issues that promote health disparities.

Background: Rapid publication of clinical trials is essential in order for the findings to yield maximal benefits for public health and scientific progress. Factors affecting the speed of publication of the main results of government-funded trials have not been well characterized., Methods: We analyzed 244 extramural randomized clinical trials of cardiovascular interventions that were supported by the National Heart, Lung, and Blood Institute (NHLBI). We selected trials for which data collection had been completed between January 1, 2000, and December 31, 2011. Our primary outcome measure was the time between completion of the trial and publication of the main results in a peer-reviewed journal., Results: As of March 31, 2012, the main results of 156 trials (64%) had been published (Kaplan-Meier median time to publication, 25 months, with 57% published within 30 months). Trials that focused on clinical events were published more rapidly than those that focused on surrogate measures (median, 9 months vs. 31 months; P<0.001). The only independent predictors of more rapid publication were a focus on clinical events rather than surrogate end points (adjusted publication rate ratio, 2.11; 95% confidence interval, 1.26 to 3.53; P=0.004) and higher costs of conducting the trial, up to a threshold of approximately $5 million (P<0.001). The 37 trials that focused on clinical events and cost at least $5 million accounted for 67% of the funds spent on clinical trials but received 82% of the citations. After adjustment of the analysis for a focus on clinical events and for cost, trial results that were classified as positive were published more quickly than those classified as negative., Conclusions: Results of less than two thirds of NHLBI-funded randomized clinical trials of cardiovascular interventions were published within 30 months after completion of the trial. Trials that focused on clinical events were published more quickly than those that focused on surrogate end points. (Funded by the National Heart, Lung, and Blood Institute.).

The Look AHEAD (Action for Health in Diabetes) Study is a long-term clinical trial that aims to determine the cardiovascular disease (CVD) benefits of an intensive lifestyle intervention (ILI) in obese adults with type 2 diabetes. The study was designed to have 90% statistical power to detect an 18% reduction in the CVD event rate in the ILI Group compared to the Diabetes Support and Education (DSE) Group over 10.5 years of follow-up. The original power calculations were based on an expected CVD rate of 3.125% per year in the DSE group; however, a much lower-than-expected rate in the first 2 years of follow-up prompted the Data and Safety Monitoring Board (DSMB) to recommend that the Steering Committee undertake a formal blinded evaluation of these design considerations. The Steering Committee created an Endpoint Working Group (EPWG) that consisted of individuals masked to study data to examine relevant issues. The EPWG considered two primary options: (1) expanding the definition of the primary endpoint and (2) extending follow-up of participants. Ultimately, the EPWG recommended that the Look AHEAD Steering Committee approve both strategies. The DSMB accepted these modifications, rather than recommending that the trial continue with inadequate statistical power. Trialists sometimes need to modify endpoints after launch. This decision should be well justified and should be made by individuals who are fully masked to interim results that could introduce bias. This article describes this process in the Look AHEAD study and places it in the context of recent articles on endpoint modification and recent trials that reported endpoint modification.

Depression is commonly present in patients with coronary heart disease (CHD) and is independently associated with increased cardiovascular morbidity and mortality. Screening tests for depressive symptoms should be applied to identify patients who may require further assessment and treatment. This multispecialty consensus document reviews the evidence linking depression with CHD and provides recommendations for healthcare providers for the assessment, referral, and treatment of depression.

Background: Evidence-based behavioral medicine (EBBM) aims to improve the process through which best scientific research evidence can be obtained and translated into best clinical decisions regarding behavioral treatments to improve health., Purpose: The objective was to examine some legitimate concerns raised by both clinicians and researchers about the evidence-based movement., Methods: This article begins with a discussion of clinicians' fears that EBBM devalues clinical judgment and the therapist-patient relationship, will be used to restrict practice, is unnecessary, and is based on research that is irrelevant to clinical decision making. Next we consider researchers' worries that EBBM neglects evidence not based on randomized controlled trials and ignores causal mechanisms., Results: We find that these fears, although understandable, largely reflect misinterpretations of the evidence-based movement. Further, it is suggested that behavioral medicine is in a unique position to enhance the evidence-based movement by encouraging increased attention to treatment mechanisms and to knowledge translation., Conclusions: Clinicians, researchers, and, importantly, the public will benefit from the evidence-based movement by having a health care system that is built on solid grounds of evidence in determining which treatments should constitute the standard of care. A full partnership between clinicians and researchers is called for to generate the practical, rigorous evidence base needed to take behavioral health treatments to the next level of scientific support and implementation.

Objective: The purpose of this review is to assess the relationship between mood disorders and development, course, and associated morbidity and mortality of selected medical illnesses, review evidence for treatment, and determine needs in clinical practice and research., Data Sources: Data were culled from the 2002 Depression and Bipolar Support Alliance Conference proceedings and a literature review addressing prevalence, risk factors, diagnosis, and treatment. This review also considered the experience of primary and specialty care providers, policy analysts, and patient advocates. The review and recommendations reflect the expert opinion of the authors., Study Selection/data Extraction: Reviews of epidemiology and mechanistic studies were included, as were open-label and randomized, controlled trials on treatment of depression in patients with medical comorbidities. Data on study design, population, and results were extracted for review of evidence that includes tables of prevalence and pharmacological treatment. The effect of depression and bipolar disorder on selected medical comorbidities was assessed, and recommendations for practice, research, and policy were developed., Conclusions: A growing body of evidence suggests that biological mechanisms underlie a bidirectional link between mood disorders and many medical illnesses. In addition, there is evidence to suggest that mood disorders affect the course of medical illnesses. Further prospective studies are warranted.

Background: Depression after myocardial infarction (MI) is associated with higher morbidity and mortality. Although antidepressants are effective in reducing depression, their use in patients with cardiovascular disease remains controversial., Objective: To undertake a secondary analysis to determine the effects of using antidepressants on morbidity and mortality in post-MI patients who participated in the Enhancing Recovery in Coronary Heart Disease study., Design: Observational secondary analysis., Setting: Eight academic sites., Patients: The Enhancing Recovery in Coronary Heart Disease clinical trial randomized 2481 depressed and/or socially isolated patients from October 1, 1996, to October 31, 1999. Depression was diagnosed using a structured clinical interview. This analysis was conducted on the 1834 patients enrolled with depression (849 women and 985 men)., Intervention: Use of antidepressant medication., Main Outcome Measures: Event-free survival was defined as the absence of death or recurrent MI. All-cause mortality was also examined. To relate exposure to antidepressants to subsequent morbidity and mortality, the data were analyzed using a time-dependent covariate model., Results: During a mean follow-up of 29 months, 457 fatal and nonfatal cardiovascular events occurred. The risk of death or recurrent MI was significantly lower in patients taking selective serotonin reuptake inhibitors (adjusted hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.38-0.84), as were the risk of all-cause mortality (adjusted HR, 0.59; 95% CI, 0.37-0.96) and recurrent MI (adjusted HR, 0.53; 95% CI, 0.32-0.90), compared with patients who did not use selective serotonin reuptake inhibitors. For patients taking non-selective serotonin reuptake inhibitor antidepressants, the comparable HRs (95% CIs) were 0.72 (0.44-1.18), 0.64 (0.34-1.22), and 0.73 (0.38-1.38) for risk of death or recurrent MI, all-cause mortality, or recurrent MI, respectively, compared with nonusers., Conclusions: Use of selective serotonin reuptake inhibitors in depressed patients who experience an acute MI might reduce subsequent cardiovascular morbidity and mortality. A controlled trial is needed to examine this important issue.

The goal of evidence-based medicine is ultimately to improve patient outcomes and quality of care. Systematic reviews of the available published evidence are required to identify interventions that lead to improvements in behavior, health, and well-being. Authoritative literature reviews depend on the quality of published research and research reports. The Consolidated Standards for Reporting Trials (CONSORT) Statement (www.consort-statement.org) was developed to improve the design and reporting of interventions involving randomized clinical trials (RCTs) in medical journals. We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence-based practice. Additional behavioral medicine-specific guidelines (e.g., treatment adherence) are also presented. Use of these guidelines by clinicians, educators, policymakers, and researchers who design, report, and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice.

Context: Depression and low perceived social support (LPSS) after myocardial infarction (MI) are associated with higher morbidity and mortality, but little is known about whether this excess risk can be reduced through treatment., Objective: To determine whether mortality and recurrent infarction are reduced by treatment of depression and LPSS with cognitive behavior therapy (CBT), supplemented with a selective serotonin reuptake inhibitor (SSRI) antidepressant when indicated, in patients enrolled within 28 days after MI., Design, Setting, and Patients: Randomized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients (1084 women, 1397 men) enrolled from 8 clinical centers. Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression (HRSD); LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI). Random allocation was to usual medical care or CBT-based psychosocial intervention., Intervention: Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months, plus group therapy when feasible, with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50% reduction in Beck Depression Inventory scores after 5 weeks., Main Outcome Measures: Composite primary end point of death or recurrent MI; secondary outcomes included change in HRSD (for depression) or ESSI scores (for LPSS) at 6 months., Results: Improvement in psychosocial outcomes at 6 months favored treatment: mean (SD) change in HRSD score, -10.1 (7.8) in the depression and psychosocial intervention group vs -8.4 (7.7) in the depression and usual care group (P<.001); mean (SD) change in ESSI score, 5.1 (5.9) in the LPSS and psychosocial intervention group vs 3.4 (6.0) in the LPSS and usual care group (P<.001). After an average follow-up of 29 months, there was no significant difference in event-free survival between usual care (75.9%) and psychosocial intervention (75.8%). There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups (depression, LPSS, and depression and LPSS patients)., Conclusions: The intervention did not increase event-free survival. The intervention improved depression and social isolation, although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients.

A major factor in the context of evaluating depression in the elderly is the role of medical problems. With aging there is a rapid increase in the prevalence of a number of medical disorders, including cancer, heart disease, Parkinson's disease, Alzheimer's disease, stroke, and arthritis. In this article, we hope to bring clarity to the definition of comorbidity and then discuss a number of medical disorders as they relate to depression. We evaluate medical comorbidity as a risk factor for depression as well as the converse, that is, depression as a risk factor for medical illness. Most of the disorders that we focus on occur in the elderly, with the exception of HIV infection. This review focuses exclusively on unipolar disorder. The review summarizes the current state of the art and also makes recommendations for future directions.

Background: Ischemia during laboratory mental stress tests has been linked to significantly higher rates of adverse cardiac events. Previous studies have not been designed to detect differences in mortality rates., Methods and Results: To determine whether mental stress-induced ischemia predicts death, we evaluated 196 patients from the Psychophysiological Investigations of Myocardial Ischemia (PIMI) study who had documented coronary artery disease and exercise-induced ischemia. Participants underwent bicycle exercise and psychological stress testing with radionuclide imaging. Cardiac function data and psychological test results were collected. Vital status was ascertained by telephone and by querying Social Security records 3.5+/-0.4 years and 5.2+/-0.4 years later. Of the 17 participants who had died, new or worsened wall motion abnormalities during the speech test were present in 40% compared with 19% of survivors (P=0.04) and significantly predicted death (rate ratio=3.0; 95% CI, 1.04 to 8.36; P=0.04). Ejection fraction changes during the speech test were similar in patients who died and in survivors (P=0.9) and did not predict death even after adjusting for resting ejection fraction (P=0.63), which was similar in both groups (mean, 56.4 versus 59.7; P=0.24). Other indicators of ischemia during the speech test (ST-segment depression, chest pain) did not predict death, nor did psychological traits, hemodynamic responses to the speech test, or markers of the presence and severity of ischemia during daily life and exercise., Conclusions: In patients with coronary artery disease and exercise-induced ischemia, the presence of mental stress-induced ischemia predicts subsequent death.

Background: Sex differences in the pathophysiologic course of coronary artery disease (CAD) are widely recognized, yet accurate diagnosis of coronary artery disease in women remains challenging., Methods: To determine sex differences in the clinical manifestation of CAD, we studied chest pain reported during daily activities, exercise, and mental stress in 170 men and 26 women. All patients had documented CAD (>50% narrowing in at least 1 major coronary artery or prior myocardial infarction) and all had 1-mm ST-segment depression on treadmill exercise. We collected psychologic test results, serum samples (potassium, epinephrine, norepinephrine, cortisol, b-endorphin, and glucose), and cardiac function, sensory threshold, and autonomic function data at specified times before, during, or after exercise and mental stress tests to assess measures of depression, anxiety, and neurohormonal and thermal pain perception., Results: Women reported chest pain more often than men during daily activities (P =.04) and during laboratory mental stressors (P =.01) but not during exercise. Men had lower scores than women on measures of depression, trait anxiety, harm avoidance, and reward dependence (P <.05 for all). Women had significantly lower plasma b-endorphin levels at rest (4.2 +/- 3.9 vs 5.0 +/- 2.5 pmol/L for men, P =.005) and at maximal mental stress (6.4 +/- 5.1 vs 7.4 +/- 3.5 pmol/L for men, P <.01). A higher proportion of women than men had marked pain sensitivity to graded heat stimuli applied to skin (hot pain threshold <41 degrees C, 33% vs 10%, P =.001)., Conclusions: Our results reflect sex differences in the affective and discriminative aspects of pain perception and may help explain sex-related differences in clinical presentations.

Purpose: Stress Management Intervention (SMI) was one of seven nonpharmacologic approaches evaluated in Phase I Trials of Hypertension Prevention (TOHP-I) for efficacy in lowering diastolic blood pressure (BP) in healthy men and women aged 30 to 54 years with diastolic BP 80-89 mm Hg., Methods: A total of 242 and 320 participants were randomized to SMI or an "assessment only" SMI Control, respectively, at four clinical centers. The SMI consisted of 37 contact hours in 21 group and two individual meetings over 18 months and included: training in four relaxation methods, techniques to reduce stress reactions, cognitive approaches, communication skills, time management, and anger management within a general problem-solving format. Standardized protocols detailed methods and timing for collecting BP, psychosocial measures, and urinary samples from both SMI and SMI Control participants., Results: In intention-to-treat analyses, although significant baseline to termination BP reductions were observed in both groups, net differences between the SMI and SMI Control groups' BP changes (mean (95% CI)) were not significant: -0.82 (-1.86, 0.22) for diastolic BP, and -0.47 (-1.96, 1.01) for systolic BP. Extensive adherence sub-group analyses found one effect: a significant 1.36 mm Hg (p = 0.01) reduction in diastolic BP relative to SMI Controls at the end of the trial for SMI participants who completed 61% or more of intervention sessions., Conclusions: While the TOHP-I SMI was acceptable to participants as evident from high levels of session completion, the absence of demonstrated BP lowering efficacy in intention-to-treat analyses suggests that the TOHP-I SMI is an unlikely candidate for primary prevention of hypertension in a general population sample similar to study participants. The isolated finding of significant diastolic BP lowering in SMI participants with higher adherence provides very weak evidence of SMI BP lowering efficacy and may be a chance finding. Whether similar or other stress management interventions can produce significant BP lowering in populations selected for higher levels of BP, stress, or intervention adherence remains to be demonstrated.

This study tested the reliability and validity of a diagnostic thermal vascular test (TVT) for patients with Raynaud's Phenomenon (RP). The TVT examined digital blood pressure responses to combined cooling and occlusion and was developed as part of the Raynaud's Treatment Study, a multicenter clinical trial comparing the efficacy of biofeedback and pharmacological treatment. A computerized system permitted efficient, accurate, and uniform testing at different geographical sites. A comparison of 199 patients with RP and 52 healthy controls is reported. The TVT showed a sensitivity of 79% and a specificity of 88%. Test-retest reliability was acceptable (r = .80). Addition of a psychological challenge failed to improve the discrimination between patients with RP and controls. The TVT separated patients with RP and controls as well as or better than existing tests and did so with enhanced ease of operation.

Objectives: The purpose of this study was to test whether cutaneous thermal pain thresholds are related to anginal pain perception., Background: Few ischemic episodes are associated with angina; symptoms have been related to pain perception thresholds., Methods: A total of 196 patients with documented coronary artery disease underwent bicycle exercise testing and thermal pain testing. The Marstock test of cutaneous sensory perception was administered at baseline after 30 min of rest on two days and after exercise and mental stress. Resting hot pain thresholds (HPTs) were averaged for the two baseline visits and divided into two groups: 1) average HPT <41 degrees C, and 2) average HPT > or =41 degrees C, to be clearly indicative of abnormal hypersensitivity to noxious heat., Results: Patients with HPT <41 degrees C had significantly shorter time to angina onset on exercise testing than patients with HPT > or =41 degrees C (p < 0.04, log-rank test). Heart rates, systolic blood pressure and rate-pressure product at peak exercise were not different for the two groups. Resting plasma beta-endorphin levels were significantly higher in the HPT <41 degrees C group (5.9+/-3.7 pmol/liter vs. 4.7+/-2.8 pmol/liter, p = 0.02). Using a Cox proportional hazards model, patients with HPT <41 degrees C had an increased risk of angina (p = 0.03, rate ratio = 2.0). These differences persisted after adjustment for age, gender, depression, anxiety and history of diabetes or hypertension (p < 0.01)., Conclusions: Occurrence of angina and timing of angina onset on an exercise test are related to overall hot pain sensory perception. The mechanism of this relationship requires further study.

Objectives: The purposes of this database study were to determine: 1) the relationship between mental stress-induced ischemia and ischemia during daily life and during exercise; 2) whether patients who exhibited daily life ischemia experienced greater hemodynamic and catecholamine responses to mental or physical stress than patients who did not exhibit daily life ischemia, and 3) whether patients who experienced daily life ischemia could be identified on the basis of laboratory-induced ischemia using mental or exercise stress testing., Background: The relationships between mental stress-induced ischemia in the laboratory and ischemia during daily life and during exercise are unclear., Methods: One hundred ninety-six stable patients with documented coronary disease and a positive exercise test underwent mental stress testing and bicycle exercise testing. Radionuclide ventriculography and electrocardiographic (ECG) monitoring were performed during the mental stress and bicycle tests. Patients underwent 48 h of ambulatory ECG monitoring. Hemodynamic and catecholamine responses were obtained during mental stress and bicycle tests., Results: Ischemia (reversible left ventricular dysfunction or ST segment depression > or = 1 mm) developed in 106 of 183 patients (58%) during the mental stress test. There were no significant differences in clinical characteristics of patients with, compared with those without, mental stress-induced ischemia. Patients with mental stress ischemia more often had daily life ischemia than patients without mental stress ischemia, but their exercise tests were similar. Patients with daily life ischemia had higher ejection fraction and cardiac output, and lower systemic vascular resistance during mental stress than patients without daily life ischemia. Blood pressure and catecholamine levels at rest and during the mental stress tests were not different in patients with, compared with those without, daily life ischemia. Patients with daily life ischemia had a higher ejection fraction at rest and at peak bicycle exercise compared with patients without daily life ischemia, but there were no other differences in peak hemodynamic or catecholamine responses to exercise. The presence of ST segment depression during routine daily activities was best predicted by ST segment depression during mental or bicycle exercise stress, although ST segment depression was rare during mental stress., Conclusions: Patients with daily life ischemia exhibit a heightened generalized response to mental stress. ST segment depression in response to mental or exercise stress is more predictive of ST segment depression during routine daily activities than other laboratory-based ischemic markers. Therapeutic management strategies might therefore focus on patients with these physiologic responses to stress and on whether lessening such responses reduces ischemia.

The objectives of this study were to compare and contrast indicators of ischemia in a well-characterized group of 196 patients with coronary artery disease, documented angiographically or by verified history of myocardial infarction, and a positive exercise test result. Myocardial ischemia occurs frequently in response to everyday stressors in patients with coronary artery disease. The Psychophysiological Interventions in Myocardial Ischemia study provides a unique opportunity to study neuroendocrine and psychological manifestations of ischemia. Patients with exercise-induced ischemia underwent exercise radionuclide ventriculography and electrocardiographic monitoring and 2 laboratory mental stressors (Speech and Stroop) after being withdrawn from cardiac medications. In addition, 48-hour ambulatory electrocardiograms were recorded during routine daily activities. Patients with a history of angina within the past 3 months reported angina during the bicycle or treadmill test with a much higher frequency than patients without such an anginal history (77% vs 26%). Ejection fraction (EF) responses to the Stroop test were abnormal in 48% of patients with an abnormal EF response to the Speech task, versus 17% in patients with a normal EF response (p <0.01). Seventy-six percent of patients had an abnormal EF response to bicycle exercise. Three indicators of ischemia (ST-segment depression, wall motion abnormality, and EF response) were compared during the same laboratory stressor and across different types of stress tests. Presence of the 3 indicators was only moderately associated during exercise, and only weak or nonsignificant associations occurred among the presence of the 3 ischemic markers during mental stress. Occurrence of the same ischemic markers was moderately associated between the 2 mental stress tasks, but few associations were found between the occurrence of the same ischemic marker during exercise and mental stress. There is a marked heterogeneity of responses to psychological and exercise stress testing using electrocardiography, ambulatory electrocardiography, or radionuclide criteria for ischemia during stress. The heterogeneity may be related to differences in the magnitude or types of physiologic responses provoked and to differences in the sensitivity and specificity of the different tests used to identify ischemia.

Objective: This study evaluated physiological, neuroendocrine, and psychological status and functioning of patients with coronary artery disease in order to clarify their role in the expression of symptoms during myocardial ischemia (MI), and to establish repeatability of responses to mental stress. Design and methods of the study are presented., Methods: One hundred ninety-six coronary artery disease patients were examined during physical and mental stress tests in four hospitals. Eligibility criteria included narrowing of at least 50% in the diameter of at least one major coronary artery or verified history of myocardial infarction, and evidence of ischemia on an exercise treadmill test. Psychological, biochemical, and autonomic function data were obtained before, during, and after exposure to mental and exercise stressors during 2 or 3 half-days of testing. Ventricular function was assessed by radionuclide ventriculography, and daily ischemia by ambulatory electrocardiography. Sixty patients returned for a short-term mental stress repeatability study. Twenty-nine individuals presumed to be free of coronary disease were also examined to establish reference values for cardiac responses to mental stress., Results: Study participants were 41 to 80 years of age; 83 (42%) had a history of MI, 6 (3%) of congestive heart failure, and 163 (83%) of chest pain; 170 (87%) were men; and 90 (46%) had ischemia accompanied by angina during exercise treadmill testing. Ischemia during ambulatory monitoring was found in 35 of 90 (39%) patients with and 48 of 106 (45%) patients without angina during exercise-provoked ischemia. Intraobserver variability of ejection fraction changes during bicycle exercise and two mental stress tests (Speech and Stroop) was good (kappa = 1.0, .90, and .76, respectively; percent agreement = 100, 97.5, and 93.8%, respectively). Variability of assessed wall motion abnormalities during bicycle exercise was better (kappa, agreement = 85%) than during Speech or Stroop kappa and .57, percent agreement = 70% and 82.5%, respectively)., Conclusions: Study design, quality control data, and baseline characteristics of patients enrolled for a clinical study of symptomatic and asymptomatic myocardial ischemia are described. Lower repeatability of reading wall motion abnormalities during mental stress than during exercise may be due to smaller effects on wall motion and lack of an indicator for peak mental stress.

Components of heart rate variability have attracted considerable attention in psychology and medicine and have become important dependent measures in psychophysiology and behavioral medicine. Quantification and interpretation of heart rate variability, however, remain complex issues and are fraught with pitfalls. The present report (a) examines the physiological origins and mechanisms of heart rate variability, (b) considers quantitative approaches to measurement, and (c) highlights important caveats in the interpretation of heart rate variability. Summary guidelines for research in this area are outlined, and suggestions and prospects for future developments are considered.

Background: The normal cardiovascular response to mental stress in middle-aged and older people has not been well characterized., Methods and Results: We studied 29 individuals 45 to 73 years old (15 women, 14 men) who had no coronary risk factors, no history of coronary artery disease, and a negative exercise test. Left ventricular (LV) volumes and global and regional function were assessed by radionuclide ventriculography at rest and during two 5-minute standardized mental stress tasks (simulated public speaking and the Stroop Color-Word Test), administered in random order. A substantial sympathetic response occurred with both mental stress tests, characterized by increases in blood pressure, heart rate, rate-pressure product, cardiac index, and stroke work index and rises in plasma levels of epinephrine and norepinephrine but not beta-endorphin or cortisol. Despite this sympathetic response, LV volume increased and ejection fraction (EF) decreased secondary to an increase in afterload. The change in EF during mental stress-varied among individuals but was associated positively with changes in LV contractility and negatively with baseline EF and changes in afterload. EF decreased > 5% during mental stress in 12 individuals and > 8% in 5; 3 developed regional wall motion abnormalities., Conclusions: Mental stress in the laboratory results in a substantial sympathetic response in normal middle-aged and older men and women, but EF commonly falls because of a concomitant rise in afterload. These results provide essential age- and sex-matched reference data for studies of mental stress-induced ischemia in patients with coronary artery disease.

Brain and rectal temperatures were measured in guinea pigs exposed to helium-oxygen environments at pressures as high as 50 bars. Very high correlations (r = .856, P less than 0.001) between the two values were observed, with an average difference of 0.47 degrees C (computed SD = 0.31). Brain temperature was usually higher than rectal. At a given ambient temperature, heat loss at 50 bars was more rapid than at 20 bars, which supports existing data for lower pressures. At 50 bars, normal equilibrium temperatures (approximately equal to 39 degrees C) could be maintained only if ambient temperature was in the vicinity of 35 degrees C. Lower ambient temperatures resulted in lower equilibrium temperatures. Between 33 and 39 degrees C, brain temperature can be predicted from rectal temperature, with an error of about 0.5 degree C.

Adult guinea pigs with electrodes chronically implanted in the optic chiasm (OC(, lateral geniculate nucleus (LGN), and visual cortex (CX) were compressed at 1 bar/min to 120 bars pressure in helium-oxygen. Body temperature was controlled to within +/- 1 degree C, CO2 was removed by a soda-lime absorbent. Electrical stimuli (50 microA, 0.05 msec) were delivered to the OC at 9.6/sec at 10 bar intervals, with pressure held constant. Pressure caused only negligible changes inthe amplitudes of pre- and postsynaptic components of potentials in the LGN. Amplitudes of evoked potentials in the CX increased approximately linearly with pressure, reaching values of up to 300% above normobaric. Latencies did not change independently of temperature. Excitability of nerve fibers changed very little, but intracortical synaptic transmission was substantially enhanced. Differences in the effects of elevated helium pressure at the LGN and CX may be attributed to differences in organization of local circuits.

Receptive fields of 245 cells in areas 17 and 18 were explored in tree shrews. Cells with simple and complex receptive fields were found in both areas but with different statistical distriubtions. A small percentage of non-oriented fields were found to be binocularly activated in both areas. Cells in area 17 preferred dark over light stimuli. Selective for direction, speed of stimulus movement, and level of background illumination, as well as combinations of these were common. Few hypercomplex cells were found. The superior retention of visually guided behavior of three shrews after lesions of the striate cortex is not explained by any radical difference between the properties of their striate neurons and those of other mammals.