Relationship of Psychological Characteristics to Daily Life Ischemia: An Analysis From the National Heart, Lung, and Blood Institute Psychophysiological Investigations in Myocardial Ischemia.

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.

The evaluation of Arkansas Act 1220 of 2003 to reduce childhood obesity: conceptualization, design, and special challenges.

This article describes the evaluation of the Arkansas Act 1220 of 2003, a comprehensive legislative proposal to address the growing epidemic of childhood obesity through changes in the school environment. In addition, the article discusses specific components of the evaluation that may be applicable to other childhood obesity policy evaluation efforts. The conceptual framework for the evaluation, research questions, and evaluation design are described, along with data collection methods and analysis strategies. A mixed methods approach, including both quantitative (surveys, telephone interviews) and qualitative (key informant interviews, records reviews) approaches, was utilized to collect data from a range of informant groups including parents, adolescents, school principals, school district superintendents, and other stakeholders. Challenges encountered with the evaluation are discussed, as are strategies to overcome those challenges. Now in its 9th year, this evaluation has documented substantial changes to school policies and environments but fewer changes to student and family behaviors. The evaluation may inform the methods of other evaluations of childhood obesity prevention policies, as well as inform policymakers about how quickly they might expect implementation of such policies in their own states and localities and anticipate both positive and adverse outcomes.

Creating and using index scores in the analysis of school policy implementation and impact.

BACKGROUND: Epidemic increases in childhood obesity and associated health risks are resulting in efforts to implement school policies related to nutrition and physical activity (NPA). With multicomponent policy efforts, challenges exist in characterizing the extent of policy change across the breadth of NPA policies. METHODS: Aggregated policy indices were created to characterize NPA policy implementation in Arkansas public schools from 2004 through 2009. Index scores are presented by year, domain, and school level. RESULTS: Both mean and median index scores increased over time, with greater changes seen in nutrition than in physical activity policy scores. The composite index score was heavily dependent on the nutrition index score and, thus, is relatively less useful for the purposes of our evaluation. Policy index scores varied by school level, rurality, enrollment size, and percentage of students eligible for federal meal programs. CONCLUSIONS: The policy index approach facilitates the consideration of the effect of school policy change in a holistic, aggregated way. School characteristics influence policy adoption, and thus, should be taken into consideration in the promotion of policy change.

Core competencies for doctoral education in public health.

The Association of Schools of Public Health (ASPH) released the Doctor of Public Health (DrPH) Core Competency Model in 2009. Between 2007 and 2009, a national expert panel with members of the academic and practice communities guided by the ASPH Education Committee developed its 7 performance domains, including 54 competencies. We provide an overview and analysis of the challenges and issues associated with the variability in DrPH degree offerings, reflect on the model development process and related outcomes, and discuss the significance of the model, future applications, and challenges for integration across educational settings. With the model, ASPH aims to stimulate national discussion on the competencies needed by DrPH graduates with the new challenges of 21st-century public health practice and to better define the DrPH degree.

Public policy versus individual rights in childhood obesity interventions: perspectives from the Arkansas experience with Act 1220 of 2003.

Childhood obesity is a major public health problem. Experts recommend that prevention and control strategies include population-based policies. Arkansas Act 1220 of 2003 is one such initiative and provides examples of the tensions between individual rights and public policy. We discuss concerns raised during the implementation of Act 1220 related to the 2 primary areas in which they emerged: body mass index measurement and reporting to parents and issues related to vending machine access. We present data from the evaluation of Act 1220 that have been used to address concerns and other research findings and conclude with a short discussion of the tension between personal rights and public policy. States considering similar policy approaches should address these concerns during policy development, involve multiple stakeholder groups, establish the legal basis for public policies, and develop consensus on key elements.

Development and evaluation of the school cafeteria nutrition assessment measures.

BACKGROUND: Foods provided in schools represent a substantial portion of US children's dietary intake; however, the school food environment has proven difficult to describe due to the lack of comprehensive, standardized, and validated measures. METHODS: As part of the Arkansas Act 1220 evaluation project, we developed the School Cafeteria Nutrition Assessment (SCNA) measures to assess food availability in public school cafeterias (n = 113). The SCNA provides a measure to evaluate monthly school lunch menus and to observe foods offered in school cafeterias during the lunch period. These measures provide information on the availability of fruit, vegetables, grains (whole or white), chips (reduced fat or regular), side dishes, main dishes, beverages, à la carte selections, and desserts, as well as information on healthier preparation of these items. Using independent raters, the inter-rater reliability of the measure was determined among a subsample of these schools (n = 32). RESULTS: All food categories assessed, with the exception of the side dish and chip categories, had inter-rater reliability rates of 0.79 or greater, regardless of school type. The SCNA scores encompassed the majority of the possible scores, indicating the ability for the measures to differentiate between school cafeterias in the availability of healthier options. CONCLUSION: These measures allow comprehensive, rapid measurement of school cafeteria food availability with high inter-rater reliability for public health and school health professionals, communities, and school personnel. These measures have the potential to contribute to school health efforts to evaluate cafeteria offerings and/or the impact of policy changes regarding school foods.

Changes in school environments with implementation of Arkansas Act 1220 of 2003.

Changes in school nutrition and physical activity policies and environments are important to combat childhood obesity. Arkansas Act 1220 of 2003 was among the first and most comprehensive statewide legislative initiatives to combat childhood obesity through school-based change. Annual surveys of principals and superintendents have been analyzed to document substantial and important changes in school environments, policies, and practices. For example, results indicate that schools are more likely to require that healthy options be provided for student parties (4.5% in 2004, 36.9% in 2008; P

Overweight children, weight-based teasing and academic performance.

BACKGROUND: School performance of overweight children has been found to be inferior to normal weight children; however, the reason(s) for this link between overweight and academic performance remain unclear. Psychosocial factors, such as weight-based teasing, have been proposed as having a possible mediating role, although they remain largely unexplored. METHODS: Random parental telephone survey data (N=1 071) of public school students collected as part of the statewide evaluation of Arkansas Act 1220, a law to reduce childhood obesity, were used. Overweight status (body mass index > 85th percentile for gender and age) and weight-based teasing were examined as predictors of poorer school performance. RESULTS: Overweight status was a significant predictor of poorer school performance (OR=1.51; 95% CI=1.01, 2.25), after adjustment for gender, school level, free and reduced lunch participation, and race. However, the addition of weight-based teasing to the model (with weight category and covariates) reduced the weight category parameter estimate by 24%, becoming non-significant (OR=1.40; 95% CI=0.93, 2.10) and indicating a possible mediating effect of weight-based teasing on the relationship between weight category and school performance. Weight-based teasing was significantly associated with school performance, with lower odds of strong school performance among weight-based teased children (OR=0.44; 95% CI=0.27, 0.74). CONCLUSION: Psychosocial variables, such as weight-based teasing, should be considered in future research examining the impact of childhood obesity on school performance and in future intervention studies.

Arkansas Act 1220 of 2003 to reduce childhood obesity: its implementation and impact on child and adolescent body mass index.

Arkansas was among the first states to pass comprehensive legislation to combat childhood obesity, with Arkansas Act 1220 of 2003. Two distinct but complementary evaluations of the process, impact, and outcomes of Act 1220 are being conducted: first, surveillance of the weight status of Arkansas children and adolescents, using the statewide data amassed from the required measurements of students' body mass indexes (BMIs); and second, an independent evaluation of the process, impact, and outcomes associated with Act 1220. Various stakeholder groups initially expressed concerns about the Act, specifically concerns related to negative social and emotional consequences for students and an excessive demand on health care. Evaluation data, however, suggest that few adverse effects have occurred either in these areas of concern or in other concerns which have emerged over time. Schools are changing environments and implementing policies and programs to promote healthy behaviors and BMI levels have not increased since the implementation of Act 1220 in 2004. The Arkansas experience to date may serve to inform the efforts of other states to adopt policies to address the epidemic of childhood obesity.

No change in weight-based teasing when school-based obesity policies are implemented.

OBJECTIVES: To examine rates of weight-based teasing before initiation of school-based childhood obesity prevention policies (Arkansas Act 1220 of 2003) and during the 2 years following policy implementation, as well as demographic factors related to weight-based teasing. DESIGN: Analysis of consecutive random cross-sectional statewide telephone surveys conducted annually across 3 years. SETTING: Sample representative of Arkansas public school students with stratification by geographic region, school level (elementary, middle, and high school), and school size (small, medium, and large). PARTICIPANTS: Parents of children enrolled in Arkansas public schools and index adolescents 14 years or older. Intervention Statewide school-based obesity policies, including body mass index screening. MAIN OUTCOME MEASURES: Survey items about weight-based teasing, other teasing, body weight and height, and sociodemographic factors, as well as school characteristics obtained from the Common Core of Data of the National Center for Education Statistics. RESULTS: At baseline, 14% of children experienced weight-based teasing by parental report. The prevalence of weight-based teasing did not change significantly from baseline in the 2 years following school-based policy changes. Children and adolescents most likely to be teased because of weight were those who were overweight, obese, white, female, and 14 years or older, as well as those teased for other reasons. Adolescent report of weight-based teasing yielded similar patterns. CONCLUSION: Although the effectiveness of school-based obesity prevention policies remains unclear, policy changes did not lead to increased weight-based teasing among children and adolescents.

Parental recognition of overweight in school-age children.

OBJECTIVE: Examine the accuracy of parental weight perceptions of overweight children before and after the implementation of childhood obesity legislation that included BMI screening and feedback. METHODS AND PROCEDURES: Statewide telephone surveys of parents of overweight (BMI > or = 85th percentile) Arkansas public school children before (n = 1,551; 15% African American) and after (n = 2,508; 15% African American) policy implementation were examined for correspondence between parental perception of child's weight and objective classification. RESULTS: Most (60%) parents of overweight children underestimated weight at baseline. Parents of younger children were significantly more likely to underestimate (65%) than parents of adolescents (51%). Overweight parents were not more likely to underestimate, nor was inaccuracy associated with parental education or socioeconomic status. African-American parents were twice as likely to underestimate as whites. One year after BMI screening and feedback was implemented, the accuracy of classification of overweight children improved (53% underestimation). African-American parents had significantly greater improvements than white parents (P < 0.0001). DISCUSSION: Parental recognition of childhood overweight may be improved with BMI screening and feedback, and African-American parents may specifically benefit. Nonetheless, underestimation of overweight is common and may have implications for public health interventions.

Weight change after myocardial infarction--the Enhancing Recovery in Coronary Heart Disease patients (ENRICHD) experience.

BACKGROUND: The relationship of changes in weight to outcomes in patients after myocardial infarction (MI) is controversial. METHODS: From the ENRICHD trial data, we assessed weight change, and the associations of baseline weight and change at follow-up with outcomes and interactions between psychosocial factors. RESULTS: At baseline, 73.6% of patients (n = 1706) were overweight or obese; 134 patients had body mass index of > or = 40. Underweight patients were more likely to die or have nonfatal recurrent MI. After controlling for covariates, overweight and obese patients had similar outcomes to normal-weight patients. Eighteen percent of patients gained > 5%, 27% lost > 5%, and 55% had < or = 5% change in weight. Compared with weight loss of < or = 5%, the risk of death (adjusted hazard ratio 1.74, P = .01) and cardiovascular death (hazard ratio 1.79, P = .04) increased with weight loss of > 5%. After propensity matching, weight loss of > 5% remained as a significant risk factor for death and cardiovascular death. There was no interaction between weight change and depression and/or social support at baseline or follow-up. Weight change was not associated with recurrent MI or cardiovascular hospitalizations. CONCLUSIONS: A large proportion of patients lose or gain > 5% of body weight after an MI. The association between obesity and lower mortality is modulated by comorbidities. Weight loss after MI is associated with worse outcomes and is not related to depression or social support.

Recommendations from the ASPH/Legacy Scholarship, Training, and Education Program for Tobacco Use Prevention (STEP UP) strategy planning meeting Chicago, May 3, 2005.

During this meeting, the participants developed a strategic set of recommendations for ASPH to continue to advance the study of tobacco control in public health through research and education/training programs. The meeting focused on sustaining and further developing tobacco-related research and education/ training programs. All four issues were addressed in depth through valuable discussion and exchange and reflected in the nine areas of focus. Recommendations for advocacy for future funding for SPH in tobacco control included developing collaborative relationships with ASPH partners, organizations, and institutions with complementary objectives (state departments of health, third party payors, etc). Priorities for sustaining and further developing research and education/training programs within SPH included developing a focus on particular research areas (e.g., special populations, economic issues, dissemination and translational issues), building on existing knowledge, and attempting to avoid the effects of "siloing" with collaborative relationships and methods for addressing the sustenance of programs beyond initial funding periods. Methods to maintain vigilance on tobacco control with increasing concerns about other risk factors included fostering an increasing awareness of tobacco-related issues, projects, and programs as well as developing collaborative relationships with organizations and institutions with complementary health-risk related objectives. Other recommendations focused on enhancing SPH leadership in the tobacco control field by developing standards and methodologies and translating research to practice. They included (1) developing standards for consistent tobacco control-related education to public health students, public health professionals, and other students and professionals; (2) developing a standardized method for evaluating tobacco-attributable factors and effects; and (3) conducting effectiveness trials of treatments known to be efficacious. Effectively addressing these perennial issues will enable SPH to enhance its leadership position and contribute greatly to research and education/training in tobacco control. All of these issues were factors in program planning for the second National STEP UP Academic Tobacco Workshop. For instance, reviews of particular research areas might be offered or facilitated as well as methods for developing collaborative partnerships and subsequent efforts. Steps toward the development of tobacco control education core competencies might be developed as well. The second National STEP UP Academic Tobacco Workshop-STEP UP to Sustain Tobacco Control and Prevention through Education and Research--was held on January 30-31, 2006. The topics of discussion ranged from use of secondary data to behavioral economics. More information about the workshop can be found at http://www.asph.org/ document.cfm?page=882. Attention to the recommendations that resulted from the planning meeting will provide a strategic platform from which ASPH and the public health community can continue to address the single greatest cause of preventable disease and death in the world.

Training community health workers to reduce health disparities in Alabama's Black Belt: the Pine Apple Heart Disease and Stroke Project.

African American women have significantly higher mortality rates from heart disease and stroke than White women despite advances in treatment and the management of risk factors. Community health workers (CHWs) serve important roles in culturally relevant programs to prevent disease and promote health. This article describes the Pine Apple Heart and Stroke Project's activities to (1) revise the Women's Wellness Sourcebook Module III: Heart and Stroke to be consistent with national guidelines on heart disease and stroke and to meet the needs of African American women living in rural southern communities; (2) train CHWs using the revised curriculum; and (3) evaluate the training program. Revisions of the curriculum were based on recommendations by an expert advisory panel, the staff of a rural health clinic, and feedback from CHWs during training. Questionnaires after training revealed positive changes in CHWs' knowledge, attitudes, self-efficacy, and self-reported risk reduction behaviors related to heart disease, stroke, cancer, and patient-provider communication. This study provides a CHW training curriculum that may be useful to others in establishing heart disease and stroke programs in rural underserved communities.

Psychosocial treatment within sex by ethnicity subgroups in the Enhancing Recovery in Coronary Heart Disease clinical trial.

OBJECTIVE: Intervening in depression and/or low perceived social support within 28 days after myocardial infarction (MI) in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial did not increase event-free survival. The purpose of the present investigation was to conduct post hoc analyses on sex and ethnic minority subgroups to assess whether any treatment subgroup is at reduced or increased risk of greater morbidity/mortality. METHODS: The 2481 patients with MI (973 white men, 424 minority men, 674 white women, 410 minority women) who had major or minor depression and/or low perceived social support were randomly allocated to usual medical care or cognitive behavior therapy. Total mortality or recurrent nonfatal MI (ENRICHD primary endpoint) and cardiac mortality or recurrent nonfatal MI (secondary endpoint) were analyzed as composite endpoints by group for time to first event using Cox proportional hazards regression. RESULTS: There was a trend in the direction of treatment efficacy for white men for the primary endpoint (hazard ratio [HR], 0.80; 95% confidence interval, 0.61-1.05; p =.10) and a significant (p <.006, Bonferroni corrected) effect for the secondary endpoint (HR, 0.63; 95% CI, 0.46-0.87; p =.004). In contrast, the HRs for each of the other three subgroups were nonsignificant. The magnitude of differences in treatment effects between white men and the other subgroups remained significant for the secondary endpoint (p =.04) after adjustment for age, education, living alone, antidepressant use, comorbidity score, cardiac catheterization, ejection fraction, history of hypertension, and major depression. CONCLUSIONS: White men, but not other subgroups, may have benefited from the ENRICHD intervention, suggesting that future studies need to attend to issues of treatment design and delivery that may have prevented benefit among sex and ethnic subgroups other than white men.

Knowledge of heart attack symptoms in 20 US communities. Results from the Rapid Early Action for Coronary Treatment Community Trial.

BACKGROUND: Effective treatment for patients with acute myocardial infarction is limited by patient delay in seeking care. Inadequate knowledge of heart attack symptoms may prolong delay. An intervention designed to reduce delay was tested in the Rapid Early Action for Coronary Treatment (REACT) Community Trial. In this report, the impact on knowledge of heart attack symptoms is presented. METHODS: Twenty communities were randomized to intervention or comparison status in a matched-pair design. Intervention strategies included community organization, public education, professional education, and patient education. The main outcome measures were based on information regarding knowledge of symptoms collected in a series of four random-digit-dialed telephone surveys. RESULTS: Knowledge of REACT-targeted symptoms increased in intervention communities. No change was observed in comparison communities. The net effect was an increase of 0.44 REACT-targeted symptoms per individual (P<0.001). The intervention effect was greater in ethnic minorities, persons with lower household incomes, and those with family or spouse history of heart attack (P<0.05). CONCLUSIONS: The REACT intervention was modestly successful in increasing the general public's knowledge of the complex constellation of heart attack symptoms. The intervention program was somewhat more effective in reaching disadvantaged subgroups, including ethnic minorities and persons with lower income. Despite these successes, the post-intervention level of knowledge was suboptimal.

An approach to coordinate efforts to reduce the public health burden of stroke: the Delta States Stroke Consortium.

Stroke is the third leading cause of death and a leading cause of disability in the United States, with a particularly high burden on the residents of the southeastern states, a region dubbed the "Stroke Belt." These five states - Alabama, Arkansas, Louisiana, Mississippi, and Tennessee - have formed the Delta States Stroke Consortium to direct efforts to reduce this burden. The consortium is proposing an approach to identify domains where interventions may be instituted and an array of activities that can be implemented in each of the domains. Specific domains include 1) risk factor prevention and control; 2) identification of stroke signs and symptoms and encouragement of appropriate responses; 3) transportation, Emergency Medical Services care, and acute care; 4) secondary prevention; and 5) recovery and rehabilitation management. The array of activities includes 1) education of lay public; 2) education of health professionals; 3) general advocacy and legislative actions; 4) modification of the general environment; and 5) modification of the health care environment. The Delta States Stroke Consortium members propose that together these domains and activities define a structure to guide interventions to reduce the public health burden of stroke in this region.

Policy and environmental indicators for heart disease and stroke prevention: data sources in two states.

INTRODUCTION: Investigators in South Carolina and Alabama assessed the availability of data for measuring 31 policy and environmental indicators for heart disease and stroke prevention. The indicators were intended to determine policy and environmental support for adopting heart disease and stroke prevention guidelines and selected risk factors in 4 settings: community, school, work site, and health care. METHODS: Research teams used literature searches and key informant interviews to explore the availability of data sources for each indicator. Investigators documented the following 5 qualities for each data source identified: 1) the degree to which the data fit the indicator; 2) the frequency and regularity with which data were collected; 3) the consistency of data collected across time; 4) the costs (time, money, personnel) associated with data collection or access; and 5) the accessibility of data. RESULTS: Among the 31 indicators, 11 (35%) have readily available data sources and 4 (13%) have sources that could provide partial measurement. Data sources are available for most indicators in the school setting and for tobacco control policies in all settings. CONCLUSION: Data sources for measuring policy and environmental indicators for heart disease and stroke prevention are limited in availability. Effort and resources are required to develop and implement mechanisms for collecting state and local data on policy and environmental indicators in different settings. The level of work needed to expand data sources is comparable to the extensive work already completed in the school setting and for tobacco control.

Physical activity patterns among women in rural Alabama.

OBJECTIVE: To explore factors associated with physically active women in a rural community. METHODS: Physical activity patterns were assessed in 585 women in rural Alabama. RESULTS: When combining leisure and nonleisure activities, 68% of women reported > or = 150 minutes per week. Active African American women tended to be younger (AOR 0.97), married (AOR 1.75), less likely to report arthritis (AOR 0.58), or give health (AOR 0.30) or motivational reasons (AOR 0.39) for not being more active; active white women were less likely to report lower health perception (AOR 0.51). CONCLUSION: Ethnic differences in factors associated with higher activity levels need to be considered in physical activity interventions.

Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial.

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.