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ORIGINAL ARTICLES |
From the Department of Psychology, University of Miami, Coral Gables, FL.
Address correspondence and reprint requests to Neil Schneiderman, Department of Psychology, University of Miami, P. O. Box 248185, Coral Gables, FL 33124-2070. E-mail: nschneid{at}miami.edu
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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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.
Key Words: cognitive behavior therapy, • depression, • perceived social support, • myocardial infarction.
Abbreviations: BDI = Beck Depression Inventory;; CBT = cognitive behavior therapy;; CI = confidence interval;; DISH = Depression Interview and Structured Hamilton;; ENRICHD = Enhancing Recovery in Coronary Heart Disease;; ESSI = ENRICHD Social Support Instrument;; HR = hazard ratio;; MI = myocardial infarction;; RCPP = Recurrent Coronary Prevention Project.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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Although some other post-MI psychosocial intervention trials have likewise not shown a positive effect on medical endpoints (2,3), two meta-analyses have reported a reduction in mortality and cardiac morbidity (4,5). The major study reporting positive results was the Recurrent Coronary Prevention Project (RCPP), which used group-based cognitive behavior therapy (CBT) and decreased hostility and depressed affect (6) and the composite medical endpoint of cardiac death and nonfatal MI (7). Whereas the RCPP, like most other post-MI rehabilitation trials was conducted primarily with white men (92%), ENRICHD enrolled a large percentage of women (44%) and minorities (34%). The ENRICHD trial found a significant (p = .03) interaction between treatment and sex on the risk of all-cause mortality or recurrent nonfatal MI (1). This interaction effect was substantially attenuated (p > .2) after adjustment for clinically important prognostic factors. The interaction between treatment and ethnic group (minority, nonminority) also was not significant.1 However, because ENRICHD deliberately enrolled a large number of diverse participants, including 973 white men, 674 white women, 424 minority men, and 410 minority women, we had the opportunity to conduct secondary post hoc analyses to examine the consistency of the intervention effect on medical endpoints in the four sex by minority subgroups.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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Eligibility, Assessment, and Randomization
Patients were recruited to 28 days after acute MI. A qualifying MI required a characteristic elevation in one or more biomarkers of myocardial injury to twice the institution-specific upper limit of normal, except for creatine kinase-MB fraction, for which any elevation with a rising and falling pattern deemed indicative of acute MI by the attending physician was considered acceptable. Patients also had to manifest either a) symptoms compatible with acute MI or b) characteristic evolutionary electrocardiographic ST-T changes or new Q waves (8). Patients who underwent intervention for ST elevation on seeking treatment could be included even if biomarker criteria were not met.
Exclusion criteria included any of the following: acute MI that occurred after coronary artery bypass graft or other invasive cardiac procedures, presence of a noncardiac condition likely to be fatal within 1 year, presence of a medical condition limiting ability to participate in the trial, participation in a concurrent behavioral research protocol that conflicted with ENRICHD, major psychiatric morbidity (eg, schizophrenia, bipolar disorder, dementia, active substance abuse), imminent suicide risk, unwillingness to provide informed consent, inability to complete screening visits, inaccessibility for intervention and/or planned follow-up, current participation in psychotherapy, or taking an antidepressant medication for less than 14 days.
Psychosocial eligibility for recruitment required that patients meet criteria for depression, low social support, or both, determined within 28 days of the onset of acute MI. Patients were classified as depressed if they met the ENRICHD modified DSM-IV diagnostic criteria for major or minor depression or dysthymia (9) based on the Depression Interview and Structured Hamilton (DISH), which was developed for the ENRICHD study (10). The DISH also yields a depression severity score on the Hamilton Rating Scale for Depression (11). Criteria for low perceived social support were based on the ENRICHD Social Support Instrument (ESSI; 12).
At a baseline visit, demographic, medical history, and electrocardiographic and physical examination data were collected. Comorbidity was assessed using the D’Hoore adapted Charlson Index (13,14), which assigns cumulative weights for each separate disorder: 1, eg, previous MI, congestive heart failure, peripheral vascular disease, or cerebrovascular disease; 2, eg, diabetes, renal disease; 3, moderate or severe liver disease; and 6, metastatic solid tumor, an exclusion criterion in this trial. The DISH, ESSI, Beck Depression Inventory (BDI) (15), and Perceived Social Support Scale (16) were administered. Patients meeting psychosocial and medical eligibility requirements were then randomized by a central coordinating center into either a psychosocial intervention or a usual care group.
Although the participants and interventionists were aware of the participants’ treatment assignment, study staff who performed endpoint data collection, verification, and classification, and those who conducted the follow-up psychosocial assessments, were blind to treatment assignment insofar as possible.
Treatment
Both the psychosocial intervention and usual care groups received written materials providing education about risk factors based on the American Heart Association Active Partnership Program (17). The basis of the ENRICHD intervention was CBT. For depressed patients, CBT as described by Beck et al. (15) and Beck (18) was used. For patients with low perceived social support, the CBT intervention was adapted to treat patients’ lack of perceived social support (1). In addition, depressed patients who scored 
24 on the Hamilton Rating Scale for Depression, or who showed <50% reduction in BDI scores after 5 weeks, were referred to study psychiatrists for consideration of pharmacotherapy, usually sertraline (1). Some intervention patients were prescribed antidepressant medication as part of the trial, but antidepressant usage was tracked for both usual care and intervention patients.
Of 43 therapists, 25 were women and 18 were men. There were 38 white, 2 Asian, 2 Hispanic, and 1 black therapist. The study intervention, therapist training, and quality control procedures are described in detail elsewhere (19). Intervention patients received individual CBT; 30% of patients also received group-based CBT. The CBT intervention continued until either a patient met the ENRICHD criteria for successful termination of treatment or 6 months had elapsed. These criteria included a) completion of at least 6 individual and/or group therapy sessions; b) demonstration of adequate self-therapy skills (ie, CBT skills to maintain treatment gains and prevent relapse); c) report by the patient of at least one sustainable, supportive relationship outside of therapy (for patients enrolled for low perceived social support); and d) two consecutive scores during weekly sessions of 7 or less on the BDI (for patients enrolled for depression) or two consecutive scores of 4 or more on at least two items on a short form of the Perceived Social Support Scale (for patients enrolled for low perceived social support).
Follow-up Evaluations
Follow-up assessments were performed 6 months after randomization and annually thereafter, for a mean of 2.4 and a maximum of 4.5 years. The assessments included a brief medical history, physical examination, resting electrocardiogram to detect otherwise unrecognized acute MI, the BDI, and the ESSI. A treatment-blind Endpoints Review Committee evaluated records for every hospitalization using standardized criteria. An electrocardiogram core laboratory classified electrocardiograms by the Minnesota code using serial change rules (20). Additional details concerning the ascertainment of endpoints are provided elsewhere (1).
Statistical Analyses
The primary prespecified medical endpoint combined recurrent nonfatal MI and death from any cause. We also used the composite endpoint of cardiac death and recurrent nonfatal MI in the present analyses because, although not prespecified for ENRICHD, it a) was the primary endpoint in the previously mentioned RCPP (7); b) decreased the number of statistical tests necessary for analyses of two prespecified ENRICHD secondary endpoints, cardiac death and nonfatal MI, by replacing the two with a composite endpoint; and c) maximized power for analyses of secondary endpoints in subgroups (eg, minority women) by combining the two prespecified secondary endpoints. Analyses were conducted after first evaluating whether there was any evidence of differential ascertainment of the cardiac death endpoint by sex and minority subgroup. Such bias might arise as a result of differences in the completeness of the documentation provided to the Endpoint Review Committee. No differences in agreement between the adjudicated and death certificate classification of cause of death (cardiac vs. noncardiac) were found.
The subgroups analyzed in this article were a) white men, b) minority men, c) white women, and d) minority women. Analysis of variance was used to test whether the continuous variables of interest differed across sex and ethnicity subgroups, and the 
2 test was used for categorical variables. Cox proportional hazards regression analysis was used to obtain subgroup-specific intervention effects on the time to an event for each of the primary and secondary endpoints. Estimates of probability of cardiovascular death or recurrent nonfatal MI were calculated for the usual care and intervention groups, and differences between groups were tested using the log-rank statistic. To investigate whether sex and ethnic minority subgroups responded differently to intervention, we included in the proportional hazards model a term for the interaction between treatment and the sex and ethnicity covariates (21). Adjustments were made for multiple comparisons (4 subgroups x 2 endpoints = 8 comparisons) by Bonferroni correction.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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The major previous study reporting positive results for a psychosocial intervention in post-MI patients was the RCPP (7). That study, which used a group-based psychosocial intervention emphasizing behavioral skills training, reduced hostility and depressed affect (6) and the composite medical endpoint of cardiac death and nonfatal MI (7). Although the RCPP trial found positive results using CBT in a cohort consisting primarily of white men, it should be noted that important differences existed between ENRICHD and the RCPP. These include medical entry criteria, absence of specific psychosocial diagnosis in RCPP, objectives of treatment, treatment timing, and treatment duration.
Some of the differences between the RCPP and ENRICHD trials may be instructive for understanding the apparent differences we observed between the white men and the other subgroups. The RCPP, for example enrolled only patients younger than 65 years who were not diabetic and who had survived for 6 months past their MI (7). The RCPP participants also had a high likelihood of being married (89%) and college educated (52%), with a low prevalence of hypertension (30%) (6). In the present article, we have observed that the white men were significantly younger, healthier, better educated, and less likely to be living alone than participants in the other subgroups, but that these factors generally appear not to have contributed to treatment outcomes. Controlling for these factors did not reduce substantially the differences in outcome between white men and other patients. It is conceivable, however, that some combination of these factors together with other variables could in part moderate the effects of psychosocial treatment.
The RCPP and ENRICHD trials differed in other important respects. For example, ENRICHD treatment began soon after acute MI and lasted for 6 months, whereas treatment in the RCPP began at least 6 months after the MI and lasted for as long as 4.5 years (6). The primary ENRICHD article has speculated on why early treatment for depression or perceived social support may not reduce medical morbidity and mortality substantially unless treatment is provided longer than the first 6 months or outside the window of greatest medical risk (1). Furthermore, the ENRICHD intervention targeted depression and/or perceived lack of social support, whereas the RCPP targeted a reduction in Type A behavior. It should be noted that whereas ENRICHD excluded 75% of medically eligible patients because they were not depressed and/or low in perceived social support, the RCPP did not screen on psychosocial criteria. Nevertheless, both the RCPP and ENRICHD showed improvement in symptoms of depressed affect and marginally significant gains in social support and well-being (1,6). White men and other participants in the present ENRICHD analysis likewise showed significant decreases in depressed affect and increases in perceived social support. Thus, the psychosocial outcomes and the composite medical outcome of cardiac death and recurrent nonfatal MI appear to be similar among the white men enrolled in ENRICHD and the largely white male participants in the RCPP trial.
In addition to the differences in demographic and medical history between the white men and the other subgroups in ENRICHD, it appears that the white men received more intensive medical treatment than women and minority participants. This is consistent with findings in a report of the Institute of Medicine indicating that cardiac procedures are used less frequently in African American patients compared with white patients (22). A variety of potential explanations for ethnic disparities in cardiac procedures have been suggested, including a) health care providers’ perceptions about differences in risk factors and disease severity (23), b) accessibility of services among population subgroups (24), and c) physicians’ patterns of diagnosing coronary disease when patients present with suspected signs and symptoms (25,26). In any event, the white men in ENRICHD appear to have received more aggressive medical treatment than other participants, which does not in itself explain why the psychosocially treated group of white men apparently fared better than the control group of white men. It is conceivable, however, that the aggressiveness of medical treatment after MI could in part moderate the effects of psychosocial treatment.
In the present report, white men showed a marginally positive effect, white women and minority men a null effect, and minority women a marginally negative effect of treatment for the primary endpoint. In contrast, the white men showed an apparent positive effect and minority men and white and minority women a null effect in terms of the combined endpoint of cardiac death and recurrent nonfatal MI. In a previous study, Frasure-Smith et al. (2) provided a home nursing intervention for distressed post-MI patients. There was no evidence of either benefit or harm for men, but a trend for higher cardiac and all-cause mortality in treated women, although there was little evidence that the intervention influenced psychological factors. Nevertheless, the findings reported here and by Frasure-Smith et al. (2) suggest the need for the inclusion of adequate numbers of women and minorities in future post-MI trials and further research to determine whether there are modifications in the ENRICHD intervention that would benefit women and minorities with coronary heart disease.
The present report sought to determine whether the apparent treatment differences in medical endpoints between white men and the other subgroups could be accounted for either by differences in the effectiveness of psychosocial treatment or by differences in treatment participation or meeting treatment criteria among the subgroups. Neither of these appears to be the case. The apparent treatment-related differences in secondary medical endpoint between the white men and other subgroups cannot be attributed to disparities in meeting prespecified psychosocial objectives or treatment criteria or in differences in participation in therapy among subgroups.
Although the overall ENRICHD trial (1) resulted in a significant decrease in depression and an increase in perceived social support between the intervention and usual care groups, these differences were small and appear not to account for the apparent treatment differences in medical endpoints that were observed for white men. Consequently, future trials should assess additional candidate factors found to influence medical endpoints in other psychosocial studies that may have been operating in the present trial. These include decreases in hostility (6), negative affect (27), arousal (28), and increases in self-efficacy, coping skills, and other aspects of social support (29). Such studies would likely benefit from examination of subclinical markers of disease that might mediate the relationships between treatment-related changes in psychosocial outcomes and differences in medical endpoints. It should also be noted that the question of whether a decrease in depression can lead to a reduction in post-MI mortality and morbidity may require a trial design leading to larger treatment differences in depression than those observed in the ENRICHD trial.
Previous studies have shown that after MI, the prognosis for women is worse than for men. Younger women (30) and African American women (31) fare more poorly. This has been attributed to greater severity of the index MI, longer delay between initial symptoms and arrival in the coronary care unit, and less aggressive therapy within the first 28 days (32). However, the present study indicates that variables such as age, education, living arrangement, Charlson comorbidity score, ejection fraction, hypertension, aggressiveness of interventional cardiology prescription of antidepressant medications, and frequency of major depression at baseline were not major moderators of treatment effects in terms of medical endpoints. To the extent that these variables collectively do not account for the apparent difference in treatment-related secondary medical endpoint between the white men and the other subgroups, it appears possible that other aspects of treatment are important.
The results of the ENRICHD clinical trial reflect in part a greater participation by women and minorities than reported in previous psychosocial intervention studies conducted on post-MI patients. Indeed, the intervention used in the present study was based on experience gained in cardiovascular clinical trials conducted largely in white men. Future trials are needed to confirm that the positive treatment effects that we apparently observed for morbidity and mortality in white men were not a result of chance. Such trials will require renewed effort to ensure that similar benefits will accrue also to minorities and women.
Based on the ENRICHD experience, future clinical trials designed to include representative populations need to consider carefully the sociodemographic attributes of the population in designing the behavioral interventions. For example, we do not know whether some subgroups would respond better to group than to individual therapy or to better demographic matching of participants and counselors. ENRICHD had few minority counselors, and fewer than a third of the participants in the ENRICHD trial received group treatment. In addition, there is at least anecdotal evidence that post-MI women patients fare better in same-sex than in mixed-sex groups (33). In any event, our present findings suggest that the design and implementation of future trials should attend to the special needs of women and minorities.
The present article has several limitations. First, because the sex by ethnicity by treatment interaction was not significant and the subgroup analyses were not specified a priori, these subgroup analyses should be considered post hoc and exploratory; the results obtained for white men could be a result of chance. Second, although cardiac death and recurrent nonfatal MI were prespecified individually as secondary endpoints in ENRICHD, their combination was not. Third, because ENRICHD excluded three quarters of medically eligible patients because they were not depressed and/or were low in perceived social support, the generalizability of the findings reported may be limited. Fourth, because of limitations in design and power, we were unable to subdivide minority groups or examine the extent to which different subgroups received only individual therapy rather than the individual plus group intervention. With these caveats in mind, the subgroup results provide an important complement to the primary ENRICHD findings and should be taken into consideration in the design of future trials.
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APPENDIX. ENRICHD INVESTIGATORS AND CLINICAL CENTERS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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Rush Presbyterian-St. Luke’s Medical Center, Chicago, IL
Lynda H. Powell, PhD (Principal Investigator), James E. Calvin, MD, David C. Clark, PhD, Steven Creech, MS, Gloria Darovic, Diane Downs, RN, Claudia Eaton, MS, RN, W. J. Elliott, MD, Joseph Fanelli, MD, Kristin Flynn, PhD, Pilar Frankowicz, Patricia Hernandez, Layla Kassem, PsyD, Alice Luten, PhD, Carlos Mendes de Leon, PhD, William S. Miles, PhD, Rocio Munoz-Dunbar, MA, Paige Pfenninger, RN, BSN, Carol Rogers Pitula, PhD, RN, Simona K. Reichmann, PhD, Nancy L. Sampson, BA, Leila Shahabi, RN, BSN, Susan Szeplakay, RN, Darla Vale, RN, John Zajecka, MD, Joe Zander, PhD.
Stanford University, Palo Alto, CA
Robert F. DeBusk, MD (Principal Investigator), Linda Balenesi, RN, Anna Casteneda, Dianne Christopherson, PhD, RN, Alison Deeter, Susan Duenke, PsyD, Lynda Fisher Forseth, Erika S. Froelicher, PhD, RN, FAAN (University of California, San Francisco, CA), Anne Blair Greiner, MS, Robin Hanna, RN, Heidi Kaiser, Sarah Lamb, RN, Simone Madan, PhD, Margaret Marnell, PhD, Kirsten Martin, RN, Nancy Houston Miller, RN, BSN, Lexa Most, RN, BSN, Kathleen Parker, RN, MSN, Stephen Rao, PhD, Peggy Raymond, Diane Strachowski, PhD, C. Barr Taylor, MD, Marcia Thompson, RN, BSN, Barbara Tremor, RN, BSN, Carl E. Thoresen, PhD.
University of Alabama at Birmingham, AL
James M. Raczynski, PhD (Principal Investigator), Barry Adams, PsyD, Stephanie Allison, RN, Melba Bandy, RN, James Barton, RN, Larry Bates, PhD, Vera Bittner, MD, Dianne Caddell, Martha Cole, Carol E. Cornell, PhD, Vicki DiLillo, PhD, Jeff Dolce, PhD, Angela Fort, RN, M. Janice Gilliland, MA, MSPH, Deborah K. Ingle, RN, Shelly Jordan, JD, BSN, Jerry Markovitz, MD, Dehryl Mason, JD, PhD, John Shuster, MD, MPH, Herman Taylor, MD, Suzanne Thompson, Patricia White, PhD, Suzan Winders, PhD (ClinSites SORRA Research).
University of Miami, Coral Gables, FL
Neil Schneiderman, PhD (Principal Investigator), Martha Diaz, Karen Esposito, MD, PhD, Marc Gellman, PhD, M. Gutt, PhD, Gail Ironson, MD, PhD, H. Jimenez, MD, Kristin Kilbourn, PhD, Gervasio Lamas, MD, F. Lopez-Jimenez, MD, MSc, Marta E. Manrique-Reichard, PhD, Judith Rey McCalla, PhD, Thomas Mellman, MD, Caridad V. Mendoza, RN, Robert Meyerburg, MD, F. Penedo, MS, Elsa Velez Robinson, RN, Patrice Saab, PhD, Rafael Sequeira, MD, Pura Teixeiro, RN, Joy Whitelock, RN, BSN.
University of Washington, Seattle, WA
Pamela Mitchell, PhD, RN (Principal Investigator), Patricia Betrus, PhD, RN, Elizabeth Bridges, MN, RN, Helen K. Budzynski, PhD, RN, Ann Buzaitis, MN, ARNP, Wan Chen, RN, Virginia Concannon, RN, BSN, Marie J. Cowan, PhD, RN, FAAN (University of California, Los Angeles, CA; Principal Investigator, 1995–1997), Susanna L. Cunningham, PhD, RN, Frances DeRook, MD, Cecily Erickson, RN, BSN, Peg Hanrahan, MS, RN, Pamela Hardin, RN, Becci Kimball, RN, BSN, Catherine Kirkness, RN, MN, David Kosins, PhD, Donald Kunz, BA, Murray Raskind, MD, Stephen Sholl, PhD, Fendley Stewart, MD, Karen Sturm, RN, Richard C. Veith, MD, Charles Wilkinson, PhD, Susan L. Woods, RN, PhD.
Washington University, St. Louis, MO
Robert M Carney, PhD (Principal Investigator), Linda Beller, RN, MSN, Kathy Bence, RN, MBA, Teresa Benoist, RN, BSN, Stephen Berger, PhD, Sarah Breeden, RN, Laura Brewer, PhD, Iris Csik, MSW, Jerome D. Cohen, MD, Paul R. Eisenberg, MD, Kelly Everard, PhD, Jane Finn, RN, BSN, Kenneth E. Freedland, PhD, Patricia Hoffman, PhD, Deirdre Kanakis, PhD, Janet Meyer, RN, BSN, Angela Misuraco, RN, BSN, Michael W. Rich, MD, Stephen Ristvedt, PhD, Kay Schneider, Debbie Sitton, RN, BSN, Judith Skala, RN, MA, Edward S. Weiss, MD.
Yale/Harvard Center, New Haven, CT, and Boston, MA
Matthew M. Burg, PhD (Principal Investigator), Lisa Berkman, PhD (Harvard University, Boston, MA; Coprincipal Investigator), David Abrams, PhD, Daniel Beck, MBA, LICSW, Paula P. Clark, RN, Susan Farber, PhD, Sandy Ginter, RN, BSN, Keith R. Gonsor, PhD, L. Howard Hartley, MD (Harvard University, Boston, MA), Peter Herbert, MD, Selby Jacobs, MD, Renée Kochevar, PhD (Harvard University, Boston, MA), Harlan Krumholz, MD, Andrew Littman, MD, Peter Manzo, PhD, Joanne McGloin, MDiv, Thalia Metalides, RN, BSN, James Muller, MD, Sandip Mukherjee, MD, Jane Sherwood, RN, BSN (Harvard University, Boston, MA), Thomas Stewart, Andrew Stohl, MD, Peter Stone, MD (Harvard University, Boston, MA), Stuart Zarich, MD.
Coordinating Center: University of North Carolina at Chapel Hill, NC
James D. Hosking, PhD (Principal Investigator, 1995–2001), Diane Catellier, DrPH (Principal Investigator, 2001-present), Hope Bryan, Linda A. Hartig, Jean Johnson, Francis Keefe, PhD (Duke University, Durham, NC), Marc Huber, MS, Varsha Shah, MSE, Kathleen Light, PhD, Lynn Martin, Ravi Mathew, MS, Aluoch Ooro, James Schaefer, MS, David Sheps (University of Florida, Gainesville, FL), MD, Guochen Song, MS, Climmon Walker, Marston E. Youngblood, MA, MPH.
Project Office: National Heart, Lung and Blood Institute, Bethesda, MD
Susan M. Czajkowski, PhD (Project Officer), Robin Hill, PhD (deceased), Sally Hunsberger, PhD, Cheryl A. Jennings, Peter Kaufmann, PhD, Sarah Knox, PhD, James Norman, PhD, Julie Reid, Carolyn C. Voorhees, PhD.
Center for Therapist Training and Quality Control: Beck Institute for Cognitive Therapy and Research, Bala Cynwyd, PA
Judith S. Beck, PhD (Director), Naomi Dank, PhD, Christine Reilly, PhD, RN, Lesile Sokol, PhD.
Electrocardiogram Reading Center: St. Louis University, St. Louis, MO
Bernard Chaitman, MD (Principal Investigator), Theresa Belgeri, RN, P. Cameron, BS, Ihor Gussak, MD, PhD, M. Miller, BA, Karen Stocke, BS, MBA, Janet Holmes, BSN.
Study Chair and Cochair
Lisa F. Berkman, PhD (Harvard University, Boston, MA; Chair), Allan Jaffe, MD (Mayo Clinic Rochester, MN; Cochair).
Data and Safety Monitoring Board
Nanette Wenger, MD (Chair), Baruch Brody, PhD, Luther Clark, MD, James Coyne, PhD, Robert M. Kaplan, PhD, Roger Kathol, MD, Genell Knatterud, PhD.
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ACKNOWLEDGMENTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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Pfizer (Pfizer Inc., New York, NY) provided sertraline (Zoloft) for the study.
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NOTES |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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Received for publication August 6, 2003.
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIX. ENRICHD INVESTIGATORS...NOTESACKNOWLEDGMENTSREFERENCES |
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N. Frasure-Smith, D. Koszycki, J. R. Swenson, B. Baker, L. T. van Zyl, M.-A. Laliberte, B. L. Abramson, J. Lambert, G. Gravel, and F. Lesperance Design and Rationale for a Randomized, Controlled Trial of Interpersonal Psychotherapy and Citalopram for Depression in Coronary Artery Disease (CREATE) Psychosom Med, January 1, 2006; 68(1): 87 - 93. [Abstract] [Full Text] [PDF]
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H. S. Lett, J. Davidson, and J. A. Blumenthal Nonpharmacologic Treatments for Depression in Patients With Coronary Heart Disease Psychosom Med, May 1, 2005; 67(Supplement_1): S58 - S62. [Abstract] [Full Text] [PDF]
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