Diabetes Care and Mental Health During the COVID-19 Pandemic: Perspectives of Adolescents with Diabetes, Parents, and Providers.

This study explored ways in which the COVID-19 pandemic impacted adolescents' diabetes management and psychosocial functioning, and how adolescents, parents, and providers viewed telemedicine. We present data from three studies: (1) a comparison of psychosocial functioning and glycemic levels before and after pandemic onset (n = 120 adolescents; 89% with type 1 diabetes), (2) an online survey of parents about pandemic-related stressors (n = 141), and (3) qualitative interviews with adolescents, parents, and medical providers about the pandemic's impacts on adolescents' diabetes care and mental health (n = 13 parent-adolescent dyads; 7 medical providers). Results suggested some adverse effects, including disrupting routines related to health behaviors and psychosocial functioning and impairing adolescents' quality of life. Despite these challenges, most participants did not endorse significant impacts. Some even noted benefits, such as increased parental supervision of diabetes management that can be leveraged beyond the pandemic. Furthermore, telemedicine offers benefits to continuity of diabetes care but presents challenges to care quality. These findings underscore the varied and unique impacts of the COVID-19 pandemic on adolescents with diabetes.

The relationship between health worry, work distress, and affective symptoms during the COVID-19 pandemic: The mediating role of hopelessness and helplessness.

OBJECTIVES: The COVID-19 pandemic presented both serious health threats and economic hardships, which were reflected in increased rates of mood and anxiety symptoms. We examined two separate distress domains, health worries and work distress, as predictors of mood and anxiety symptoms. Additionally, we considered whether these two domains might be uniquely associated with the development of dysfunctional beliefs, as a proposed mechanism to account for increased symptoms during the pandemic. Two separate models were considered to examine if associations remained stable through the first year of the pandemic. METHODS: Participants (N = 2152) were a representative sample of Florida adults. They completed online surveys at three waves: Wave 1 (April-May 2020), Wave 2 (May-June 2020), and Wave 3 (December-February 2021). Participants completed measures of COVID-19 health worry and work distress, anxiety, and depression. They also reported their level of hopelessness and helplessness (indices of dysfunctional beliefs). RESULTS: In an early pandemic model (Wave 1-Wave 2), health worry directly and indirectly predicted anxiety and depression via dysfunctional beliefs. In contrast, work distress only indirectly predicted both outcomes. In a longer-term model (Wave 2-Wave 3), health worry had direct and indirect effects on downstream anxiety but not depression. Pandemic work distress had no effect on depression or dysfunctional beliefs; however, it was associated with less anxiety. CONCLUSIONS: Although health worry and work distress predicted later symptoms of anxiety and depression, they appeared to operate through different pathways. These findings provide guidance for the development of more effective interventions to reduce the impact of pandemics.

Psychosocial screening in a pediatric diabetes clinic: Adolescents' and mothers' perspectives.

OBJECTIVE: Adolescents with type 1 diabetes (T1D) frequently experience psychosocial concerns, and mental health screening is becoming increasingly common in routine diabetes care. However, little is known about what adolescents or their caregivers think about the role of mental health screening and intervention within the context of comprehensive diabetes care, or how their diabetes care providers should be involved in navigating mental health concerns. This study used qualitative methods to obtain the perspectives of adolescents with T1D and their caregivers regarding these issues. METHODS: Participants were 13 adolescents with T1D (ages 12-19 years; M = 15.1 years; 53.8% female; 61.5% Hispanic/Latinx White) and 13 mothers, recruited from an outpatient pediatric endocrinology clinic in South Florida, who participated in semi-structured interviews via video teleconference. Thematic content analysis was used to evaluate participants' responses. RESULTS: Adolescents and their mothers reported positive experiences with the clinic's psychosocial screening procedures and appreciated meeting with the psychology team during visits. They wanted the clinic to offer more opportunities for peer support. Mothers highlighted barriers to seeking mental health care outside of the clinic and the importance of mental health professionals understanding diabetes. Mothers also wanted the clinic to offer more on-site therapeutic services. DISCUSSION: Study participants valued psychosocial screening and supported addressing mental health as a routine part of diabetes comprehensive care.

Cardiovascular reactivity and cardiometabolic risk in adolescents.

BACKGROUND: Cardiovascular reactivity has been examined as a risk marker or factor in the pathogenesis of hypertension or cardiovascular disease, but few have examined the relationship with the metabolic syndrome. PURPOSE: We examined whether cardiovascular reactivity to laboratory stress is associated with individual cardiometabolic risk factors and their co-occurrence. A significant positive relationship was hypothesized for both individual and clustered risk factors in their cross-sectional associations with reactivity to multiple stressors. METHODS: A sample of 144, 15-17-year-old adolescents (74 % boys) largely from ethnic minority groups (54 % Hispanic White, 26 % Black) were identified at annual blood pressure (BP) screening (39 % with elevated BP) at high schools in Miami, Florida, USA. Participants completed the evaluated speaking, mirror star tracing, and cold pressor tasks, as well as cardiometabolic risk factor blood sampling. Participants were classified into metabolic syndrome criterion groups (0, 1, 2, or ≥3 criteria) based on American Heart Association adult criteria. RESULTS: Multiple regression analyses with individual metabolic syndrome variables demonstrated that diastolic (D)BP reactivity during the mirror star tracing task accounted for 1.3 %, 3.8 %, and 5.1 % of the respective variances in casual systolic BP, waist circumference, and triglycerides (ps < 0.05). In multinomial logistic regression models, increased DBP reactivity during mirror star tracing and cold pressor tasks, and decreased HR reactivity during the cold pressor, were associated with greater likelihood of risk factor co-occurrence (ranging from 8.3 % to 15.8 %). CONCLUSIONS: Findings indicate that autonomic reactivity to the mirror star tracing and cold pressor tasks, but not the evaluated speaking task, is associated with risk factor co-occurrence, and reactivity may be a clinical prognosticator of cardiometabolic disease risk.

Trait and situation-specific intolerance of uncertainty predict affective symptoms during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic, a high-uncertainty situation, presents an ideal opportunity to examine how trait intolerance of uncertainty (IU) and situation-specific IU relate to each other and to mental health outcomes. The current longitudinal study examined the unique associations of trait and COVID-specific IU with general distress (anxiety and depression) and pandemic-specific concerns (pandemic stress and vaccine worry). METHODS: A community sample of Florida adults (N = 2152) was surveyed online at three timepoints. They completed measures of trait IU at Wave 1 (April-May 2020) and COVID-specific IU at Wave 2 (May-June 2020). At Wave 3 (December-February 2021), they reported symptoms of depression, anxiety, pandemic stress, and vaccine worry. RESULTS: We used structural equation modeling to test our overall model. Trait IU significantly predicted later COVID-specific IU, however there was no significant effect of trait IU on any outcome measure after accounting for COVID-specific IU. Notably, COVID-specific IU fully mediated the relationship between trait IU and all four symptom measures. LIMITATIONS: There were several limitations of the current study, including the use of a community sample and high participant attrition. CONCLUSIONS: Results suggest that COVID-specific IU predicts mental health outcomes over and above trait IU, extending the existing literature. These findings indicate that uncertainty may be more aversive when it is related to specific distressing situations, providing guidance for developing more specific and individualized interventions. Idiographic treatments which target situation-specific IU may be more efficacious in reducing affective symptoms and related stress during the COVID-19 pandemic or other similar events.

Risk estimation in relation to anxiety and depression for low probability negative events.

Foundational cognitive models propose that people with anxiety and depression show risk estimation bias, but most literature does not compute true risk estimation bias by comparing people's subjective risk estimates to their individualized reality (i.e., person-level objective risk). In a diverse community sample (N = 319), we calculated risk estimation bias by comparing people's subjective risk estimates for contracting COVID-19 to their individualized objective risk. Person-level objective risk was consistently low and did not differ across symptom levels, suggesting that for low probability negative events, people with greater symptoms show risk estimation bias that is driven by subjective risk estimates. Greater levels of anxiety, depression, and COVID-specific perseverative cognition separately predicted higher subjective risk estimates. In a model including COVID-specific perseverative cognition alongside anxiety and depression scores, the only significant predictor of subjective risk estimates was COVID-specific perseverative cognition, indicating that symptoms more closely tied to feared outcomes may more strongly influence risk estimation. Finally, subjective risk estimates predicted information-seeking behavior and eating when anxious, but did not significantly predict alcohol or marijuana use, drinking to cope, or information avoidance. Implications for clinical practitioners and future research are discussed.

Cardiometabolic risk in adolescents: associations with physical activity, fitness, and sleep.

BACKGROUND: Physical activity and fitness are independently associated with cardiometabolic dysfunction, and short sleep duration is an emerging marker of obesity. Few have examined interrelations among these factors in a comprehensive risk model. PURPOSE: Investigate the influence of behavioral and lifestyle risk factors on the metabolic syndrome and inflammation. METHODS: A sample of 367 15-17-year-olds (73 % boys) from ethnic minority groups (45.8 % Hispanic, 30.8 % Black), most with elevated blood pressure (72 %), underwent aerobic fitness testing, blood sampling, and completed behavioral questionnaires. RESULTS: Structural model results are consistent with the notion that short sleep duration, poor sleep quality and fatigue, and decreased physical activity are associated with increased risk of metabolic syndrome and inflammation possibly via effects on reduced cardiorespiratory fitness. CONCLUSIONS: The combination of negative lifestyle and behavioral factors of physical inactivity, sleep loss, and poor fitness has serious implications for cardiovascular health complications in at-risk youth.

Psychosocial and health stressors during the COVID-19 pandemic and their association with sleep quality.

OBJECTIVE: We investigated how psychosocial and health stressors and related cognitive-affective factors were differentially associated with sleep quality during the early months of the COVID-19 pandemic. METHODS AND MEASURES: Adults living in Florida (n = 2,152) completed a Qualtrics survey in April-May 2020 (Wave 1). Participants (n = 831) were reassessed one month later (Wave 2; May-June 2020). At Wave 1, participants reported their level of physical contact with someone they care about, presence of a pre-existing chronic disease, employment status, loneliness, health worry, and financial distress. At Wave 2, participants rated their quality of sleep and insomnia symptoms. RESULTS: Loneliness, but not health worry or financial distress, directly predicted worse sleep quality. Lack of physical contact was indirectly associated with worse sleep quality via greater levels of loneliness. Further, results showed the presence of a pre-existing chronic disease was associated with both greater health worry and worse sleep quality. CONCLUSION: Loneliness was the sole cognitive-affective predictor of worse sleep quality when controlling for other psychosocial factors. As expected, adults living with a chronic disease reported impaired sleep quality. Understanding the processes influencing sleep quality during a significant time of stress is important for identifying risk factors, informing treatment, and improving sleep health beyond the pandemic.

Elevated body mass index and obesity among ethnically diverse adolescents.

OBJECTIVE: To examine trends in prevalence and odds of elevated body mass index (BMI) and obesity among ethnically diverse adolescents. DESIGN AND SETTING: Data from countywide (Miami-Dade) health screenings from 1999-2005. Weight, height, days/week of vigorous activity, hours/day of sedentary activity, parental hypertension, and eating habits were reported. PARTICIPANTS: 77,050 adolescents, average age 15.6 years (51% girls, 9.4% White non-Hispanic, 59.2% White Hispanic, 16.4% African American, 7% Black Hispanic, and 8% Black Caribbean). OUTCOME MEASURES: Prevalence and ethnic differences in odds of obesity (BMI > or = 95th percentile) and elevated BMI (BMI > or = 85th percentile), adjusting for academic years, days/week of vigorous activity, and hours/day of sedentary activity. RESULTS: Prevalence of elevated BMI and obesity increased from 1999-2005. Overall, White non-Hispanics had lower odds of obesity and elevated BMI than African Americans and White Hispanics. African American girls displayed higher odds of obesity and elevated BMI than Black Hispanic girls and higher odds of elevated BMI than Black Caribbean girls. African American boys showed higher odds of obesity and elevated BMI than Black Caribbean boys. Black Hispanic girls had greater odds of obesity and elevated BMI than White Hispanic girls, but boys were similar. CONCLUSIONS: This study is among the first to examine BMI status in both Black and Hispanic subgroups. Viewing Black and Hispanic ethnic subgroups as homogeneous obscures important weight-related differences. Further research is warranted to determine factors contributing to differential risk.

Complexity of antidiabetic medication regimen is associated with increased diabetes-related distress in persons with type 2 diabetes mellitus.

INTRODUCTION: Diabetes-related distress is present in a high proportion of people with type 2 diabetes mellitus. We hypothesized that complexity of the antidiabetic medication regimen is a factor that is associated with diabetes-related distress. RESEARCH DESIGN AND METHODS: This was a retrospective study including a group of 74 patients managed at a tertiary care center. Patients with type 1 diabetes mellitus, steroid-induced diabetes, post-transplant diabetes, and other types of diabetes were excluded. Patients were screened using the Diabetes Distress Scale-2 (DDS-2). A Diabetes Medication Complexity Scoring (DMCS) system was developed to objectively assess the diabetes medication complexity. Based on DMCS, participants were categorized into three groups: low (n=26), moderate (n=22), and high (n=26) medication complexity. RESULTS: Complexity groups were similar in sociodemographic characteristics, diabetes duration, body mass index, and blood pressure as well as the prevalence of hypertension, hyperlipidemia and hypoglycemic episodes. However, there were significant differences for HbA1c with higher HbA1c in the high and moderate complexity groups than in the low group (p=0.006). The microvascular complications were also more common in higher complexity groups (p=0.003). The prevalence of diabetes-related distress (DDS-2 ≥6) was 34.6% in the low, 36.4% in the moderate and 69.2% in the high complexity groups (p=0.021). There were significant differences in DDS-2 score among complexity groups (p=0.009), with higher DDS-2 score in the high complexity group compared with the moderate (p=0.008) and low complexity groups (p=0.009). The difference in DDS-2 score remained significant after adjusting for HbA1c (p=0.024) but did not reach statistical significance after controlling for both HbA1c and microvascular complications (p=0.163). CONCLUSIONS: A complex antidiabetic medication regimen may be associated with high levels of diabetes-related distress.

Are Self-Efficacy and Weight Perception Associated With Physical Activity and Sedentary Behavior in Hispanic Adolescents?

Little is known about the correlates of physical activity and sedentary behavior in Hispanic adolescents. This study examined at baseline and 2-year follow-up: (1) the relationship between self-efficacy for physical activity and physical activity, (2) the association of weight perception with physical activity and sedentary behavior, and (3) whether sex moderated these associations. Hispanic adolescents ( N = 483 at baseline; age 15-17 years; 55.1% girls) completed questionnaires that assessed their self-efficacy for physical activity, weight perception, and time spent in physical activity and sedentary behavior. Multiple-group path analyses were conducted to examine the proposed relationships and determine whether they were moderated by sex. Models controlled for body mass index, weight loss intention, participation on a sports team, language spoken at home, parental education, and country of birth. Self-efficacy was related to time spent in physical activity in boys ( b = .35, p < .001) and girls ( b = .41, p < .001) at baseline, but not 2 years later. No association was found for weight perception and time spent in physical activity and sedentary behavior. Post hoc analyses for overweight participants at baseline showed that weight perception was associated with time spent watching television. Overall, the findings suggest that self-efficacy is an important correlate, but not a predictor, of physical activity among Hispanic adolescents. Including strategies to address and enhance self-efficacy for physical activity in lifestyle interventions may increase adherence to physical activity recommendations and help reduce the high prevalence of obesity in this population.

Predictors of treatment response for depression and inadequate social support--the ENRICHD randomized clinical trial.

OBJECTIVE: To determine whether the 'dose' of treatment exposure, delivery of specific components of cognitive behavior therapy (CBT), patient adherence and/or use of antidepressants predict favorable depression and social support outcomes after 6 months of cognitive behavioral treatment. METHODS: Secondary analyses of the intervention arm of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial involving persons with acute myocardial infarction (MI): n = 641 for the depression outcomes and n = 523 for the social support outcomes. The outcome measures were, for depression: the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HAM-D); for social support: the ENRICHD Social Support Instrument (ESSI) and Perceived Social Support Scale (PSSS). RESULTS: Better depression outcomes (measured by the BDI) were receiving a high number of depression-specific intervention components, p < 0.01, and completing a high proportion of homework assignments, p < 0.02. Better depression outcomes (measured by the HAM-D) were receiving a high number of the social communication and assertiveness components of the intervention, p < 0.01, and completing a high proportion of homework assignments, p < 0.01. Better social support outcomes (measured by the ESSI and PSSS) were predicted by membership in a racial or ethnic minority group, p < 0.02 and p < 0.01, respectively; and by completing a higher number of homework assignments, p < 0.01 and p < 0.05, respectively. Delivery of the social communication and assertiveness components of the intervention was an independent predictor of a worse social support outcome, p < 0.01 (measured by the PSSS). CONCLUSIONS: The standard components of CBT for depression are useful in treating comorbid depression in post-MI patients. Working on communication skills may help to improve depression but not necessarily social support outcomes in this patient population, while adherence to cognitive-behavioral homework assignments is important for both outcomes. Other components of the ENRICHD intervention that were designed to improve social support had no discernible effects on outcomes. Intervention refinements may be needed in order to achieve better results in future post-MI clinical trials. A greater emphasis on CBT homework adherence could improve both depression and social support outcomes.

Lifestyle factors, body mass index, and lipid profile in adolescents.

OBJECTIVE AND METHODS: A model specifying body mass index (BMI) as mediating the relationship between lifestyle factors (aerobic fitness determined by peak oxygen consumption; physical activity by 7-day physical activity recall; diet by 24 hr dietary recall), and lipid profile were tested in a sample of 205 adolescents (73% boys), who were on average at risk of overweight, aerobically unfit, and from ethnic minority groups. RESULTS: In this well-fitting model, consuming a diet low in fat and cholesterol, and being aerobically fit predicted lower BMI, which together resulted in increases in high-density lipoprotein cholesterol and decreases in triglycerides and low-density lipoprotein cholesterol. Being physically active, predicted greater aerobic fitness. CONCLUSIONS: In addition to furthering understanding of the interrelationships among predisposing, major, and conditional coronary heart disease risk factors in adolescents, these data suggest that improving diet and aerobic fitness will reduce BMI and result in a better lipid profile.

The epidemiology, pathophysiology, and management of psychosocial risk factors in cardiac practice: the emerging field of behavioral cardiology.

Observational studies indicate that psychologic factors strongly influence the course of coronary artery disease (CAD). In this review, we examine new epidemiologic evidence for the association between psychosocial risk factors and CAD, identify pathologic mechanisms that may be responsible for this association, and describe a paradigm for studying positive psychologic factors that may act as a buffer. Because psychosocial risk factors are highly prevalent and are associated with unhealthy lifestyles, we describe the potential role of cardiologists in managing such factors. Management approaches include routinely screening for psychosocial risk factors, referring patients with severe psychologic distress to behavioral specialists, and directly treating patients with milder forms of psychologic distress with brief targeted interventions. A number of behavioral interventions have been evaluated for their ability to reduce adverse cardiac events among patients presenting with psychosocial risk factors. Although the efficacy of stand-alone psychosocial interventions remains unclear, both exercise and multifactorial cardiac rehabilitation with psychosocial interventions have demonstrated a reduction in cardiac events. Furthermore, recent data suggest that psychopharmacologic interventions may also be effective. Despite these promising findings, clinical practice guidelines for managing psychosocial risk factors in cardiac practice are lacking. Thus, we review new approaches to improve the delivery of behavioral services and patient adherence to behavioral recommendations. These efforts are part of an emerging field of behavioral cardiology, which is based on the understanding that psychosocial and behavioral risk factors for CAD are not only highly interrelated, but also require a sophisticated health care delivery system to optimize their effectiveness.

Translation of the Diabetes Prevention Program to Ethnic Communities in the United States.

The Diabetes Prevention Program (DPP), an evidenced-based lifestyle intervention for type 2 diabetes (T2D), has been translated for use with ethnic minority communities throughout the United States that are disproportionately at-risk for T2D. The present paper sought to critically review ethnic translation studies of the DPP with respect to translation methods utilized, the success of these methods, and alternative or supplemental methodologies for future translation efforts. Manuscripts reviewed were found by searching PubMed and PsycINFO, using the terms: "diabetes prevention program" AND ["translation" or "ethnic"]. Of 89 papers found, only 6 described ethnic translations of the DPP in the United States, and were included in this review. Translations of the DPP to African American, Hispanic/Latino, Native Hawaiian and Other Pacific Islander, Arab American, and American Indian and Native Alaskan communities were identified and reviewed. The most common translation strategies included group-based delivery and use of bilingual study personnel. Generally, these factors appeared to increase acceptability of the intervention within the ethnic communities reviewed, and should be considered in future efforts to implement and translate the DPP to ethnic communities in the United States.

Behavioral indices of threat and challenge in Hispanic adolescents and hemodynamic responses to a speech stressor.

Behavioral ratings of performance and nervousness during a speech were used to divide participants (n=54) into threat and challenge groups. Comparisons on cardiac output, Heather index, heart rate, vascular resistance, and blood pressure reactivity indicated greater myocardial responses for the challenge group. This study extends the threat-challenge literature by employing behavioral definitions of constructs and examining a Hispanic adolescent sample.

Applying latent growth curve modeling to the investigation of individual differences in cardiovascular recovery from stress.

OBJECTIVE: This paper provides an introduction to latent growth curve (LGC) modeling, a modern method for analyzing data resulting from change processes such as cardiovascular recovery from stress. LGC models are superior to traditional approaches such as repeated measures analysis of variance and simple change scores. METHODS: The basic principles of LGC modeling are introduced and applied to data from 167 men and women whose systolic blood pressure was assessed before, during, and after the cold pressor and evaluated speech stressors and who had completed the Cook-Medley Hostility Inventory. RESULTS: The LGC models revealed that systolic blood pressure recovery follows a different nonlinear trajectory after speech relative to the cold pressor. The difference resulted not from the initial decline at the completion of the stressor, but from higher levels at the end of the stressor and slower rate of change in decline for the speech. Hostility predicted the trajectory for speech but not for cold pressor. This relationship did not differ as a function of gender, although men had larger systolic blood pressure responses than women to both stressors. CONCLUSIONS: LGC modeling yields an understanding of the processes and predictors of change that is not attainable through traditional statistical methods. Although our application concerns cardiovascular recovery from stress, LGC modeling has many other potential applications in psychosomatic research.

Depression and late mortality after myocardial infarction in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) study.

OBJECTIVE: The Enhancing Recovery in Coronary Heart Disease study was a multicenter clinical trial in which patients with depression and/or low perceived social support after an acute myocardial infarction were randomly assigned to an intervention consisting of cognitive behavior therapy and, in some cases, sertraline, or to usual care. There was no difference in survival between the groups. A possible reason why the intervention failed to affect survival is that too many patients with mild, transient depression were enrolled. Another is that some patients died too soon to complete the intervention. This analysis evaluates whether there was a difference in late (ie, > or =6 months after the myocardial infarction) mortality among initially depressed patients who had a Beck Depression Inventory score > or =10 and a past history of major depression, and who completed the 6-month post-treatment assessment. It also examines the relationship between change in depression and late mortality. METHODS: Out of the 1,165 (47%) of the Enhancing Recovery in Coronary Heart Disease study participants who met our criteria, 57 died in the first 6 months, and 858 (409 usual care, 449 intervention) completed the 6-month assessment. Cox regression was used to analyze survival. RESULTS: The intervention did not affect late mortality. However, intervention patients whose depression did not improve were at higher risk for late mortality than were patients who responded to treatment. CONCLUSIONS: Patients whose depression is refractory to cognitive behavior therapy and sertraline, two standard treatments for depression, are at high risk for late mortality after myocardial infarction.

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.