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ORIGINAL ARTICLES |
From the ENRICHD Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina. ENRICHD investigators are listed in the Appendix.
Address reprints requests to: The ENRICHD Coordinating Center, University of North Carolina, Department of Biostatistics, CB#8030, Collaborative Studies Coordinating Center, 137 East Franklin Street, Suite 203, Chapel Hill, NC 27514-4145.
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ABSTRACT |
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METHODS: Key features of the intervention include the integration of cognitive-behavioral and social learning approaches to the treatment of depression and a diverse set of problems that can contribute to low social support; rapid initiation of treatment after MI; a combination of individual and group modalities; adjunctive pharmacotherapy for severe or intractable depression; training, certification, and supervision of therapists; and quality assurance procedures.
RESULTS: The trial’s psychosocial and medical outcomes will be presented in future reports.
CONCLUSIONS: The ENRICHD protocol targets two complex psychosocial risk factors with a multifaceted intervention, which is delivered in an individualized manner to accommodate a demographically, medically, and psychiatrically diverse patient population. Additional research will be needed to identify optimal matches between patient characteristics and specific components of the intervention.
Key Words: myocardial infarction • coronary heart disease • depression • social support • clinical trials
Abbreviations: ENRICHD = Enhancing Recovery in Coronary Heart Disease Patients;; MI = myocardial infarction;; CHD = coronary heart disease;; CAD = coronary artery disease;; CBT = cognitive behavior therapy;; DISH = depression interview and structured Hamilton;; DIS = diagnostic interview schedule;; LPSS = low perceived social support;; BDI = Beck Depression Inventory;; SSRI = selective serotonin reuptake inhibitor;; PSSS = Perceived Social Support Scale.
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INTRODUCTION |
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Low social support has also been linked to morbidity and mortality, independent of disease severity, in patients with CAD or MI. Ruberman et al. (13) reported a greater than four-fold increase in post-MI mortality among men with low perceived social support and high life stress, whereas Gorkin et al. (14) found the level of perceived social support to be a significant multivariate predictor of mortality in a similar population. Orth-Gomer et al. (15) found that socially isolated men with CAD had three times the rate of total mortality as nonisolated men, although others (16, 17) have found that patients who were married at the time of an MI were significantly less likely to die during hospitalization and follow-up than their unmarried peers. Williams et al. (5) found that CAD patients who were unmarried and/or without a confidant had a significantly lower 5-year survival rate than patients who were married, had a confidant, or both. Similarly, living alone has been found to be an independent risk factor for mortality after MI (18). Lastly, in a study of elderly men and women hospitalized with MI, perceived presence of emotional support before the MI was found to be the most powerful and consistent predictor of survival, with perceived lack of such support related to in-hospital, 6-month, and 12-month mortality (3).
The negative impact of depression and low perceived social support on post-MI prognosis underscores the need for interventions to address these problems. There have been few studies of treatments specifically targeting these psychosocial risk factors in post-MI patients. Other intervention trials for cardiac patients, however, suggest the promise of such efforts. For example, the Recurrent Coronary Prevention Project compared a group-based cognitive behavioral intervention for reduction of type A behavior with standard cardiological counseling (19). The cognitive-behavioral treatment resulted in decreased depression (20), improved quality of social interaction (19), and lower 4.5-year total, fatal, and nonfatal cardiac recurrence rate, compared with controls (19). In other studies, post-MI group-based psychoeducational interventions resulted in significantly fewer coronary deaths (21), and recurrences (22) at 3- to 4-year follow-up. In the Ischemic Heart Disease Life Stress Monitoring Study (23, 24), male post-MI patients who received monthly phone monitoring regarding symptoms of stress, and nurse-delivered, home-based interventions when stress levels were high, had significantly fewer recurrent MIs than male patients who received standard medical care. Recent work from these investigators did not replicate the earlier results (25). Further analyses of the data, however, revealed that those patients who responded to the support intervention within two home visits showed improved medical outcomes, whereas those who continued to display high levels of distress worsened (26). This indicates the importance of designing interventions that specifically target the presenting psychosocial problem.
Several studies have shown no demonstrable benefit of psychosocial interventions for post-MI patients (27, 28). These studies, however were limited by small sample sizes or insufficient power, flawed randomization procedures, inadequate or unreliable ascertainment of clinical endpoints, brief follow-up periods, differential loss to follow-up of treatment and control groups, and absence of "intention to treat" analyses. In addition, these interventions were not directed specifically at depression or low social support. Two more recent trials demonstrated no beneficial effect on cardiac mortality associated with a "psychological rehabilitation" or distress reduction treatment (25, 29). These studies, however, failed to impact participants’ psychosocial risk status (eg, depression). The ENRICHD trial was, therefore, established to determine the impact on subsequent morbidity and mortality of treatment for depression and low social support in post-MI patients.
ENRICHD is sponsored by the National Heart, Lung, and Blood Institute (NHLBI). The study’s design and baseline data have been published elsewhere (30). Briefly, 2481 patients were recruited for the study from eight clinical centers across the United States between October 1996 and October 1999 (see Table 1 for a profile of recruited patients). Participants were patients recovering from acute MI who, when screened during the first 28 days after their index event, met DSM-IV criteria for major depression, minor depression with a history of major depression, or dysthymia, and/or the ENRICHD criteria for LPSS. Patients who met all of the study’s eligibility criteria were randomized either to a psychosocial, or to a usual care condition; those assigned to intervention also received adjunctive pharmacotherapy if needed for severe or unremitting depression. The study’s primary endpoints are all-cause mortality, or recurrent nonfatal MI; secondary end points include depression, LPSS, cardiovascular mortality, revascularization, cardiovascular hospitalizations, change in cardiac risk factor profile, and health-related quality of life. The study was designed with a power of approximately 0.88 to detect a treatment effect of 30% in patients adhering to the treatment, or an observed treatment effect of 24% in all patients (assuming a nonadherence rate of 25%).
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CBT and other social learning approaches served as the basis for the intervention. In earlier clinical trials, CBT has been found to be as effective as imipramine in the treatment of depression (31). In addition, these approaches have been shown to be an effective treatment for depression for older adults (32, 33), for those with severe depression (31, 34), and for minorities, when the therapist has sufficient cultural sensitivity (35). For patients who are depressed, socially withdrawn with poor social skills, or both, these approaches have been found superior to other approaches (36, 37). As relatively brief goal-oriented, collaborative, and emotionally supportive forms of treatment, cognitive-behavioral and social learning approaches are generally well accepted by cardiac patients. They can be adapted to the mild-to-moderate depressions commonly observed in this population, and to those issues that contribute to a subjective sense of low social support (38). In addition, cognitive-behavioral group therapy has been found effective in the treatment of major depression (39), minor depression (39–41), and psychological distress (40–42). It has been widely used in work with chronic medical populations (43–46), and is particularly well suited to patients with CHD (19, 47, 48).
CONCEPTUAL FRAMEWORK
The design of the ENRICHD intervention was guided by a number of considerations. First, the risk of post-MI mortality is greatest in the first few months after the index event (49). Thus, to maximize the odds of a reduction in mortality risk, it was necessary to initiate the intervention as rapidly as possible after the MI and to treat the patients intensively. Second, the intervention had to use therapeutic approaches previously found to be effective with the target risk factors and with the target population, particularly because ineffective interventions with this population had the potential for increasing patient mortality (26). Third, the intervention had to be cost-effective. Last, although the intervention had to be standardized, operationalized in a manual of operations, and administered uniformly across eight clinical centers, it also had to be decidedly flexible to enable the counselors to accommodate a broad range of clinical presentations and the regional, cultural, and ethnic diversity of the ENRICHD sample. The locations of the study’s clinical sites range from large, densely populated inner city settings, to small, thinly populated rural settings. To address these issues, CBT and social learning approaches, which focus on rapid social behavioral activation, active problem solving, alteration of dysfunctional automatic thoughts, and coping skills training, were used. In addition, to maximize the intervention’s cost-effectiveness without sacrificing the prospects for rapid initiation and intensive delivery of treatment, it was necessary to use a combination of individual and group treatment modalities.
STRUCTURE
Individual treatment typically was provided in the counselors" offices and/or participants’ homes. Individual sessions usually lasted 1 hour and were conducted weekly, although shorter and more frequent sessions were used when needed either to reduce patient burden, especially early after the MI when patients are often easily fatigued or overwhelmed, or to address crises, severe depression, or suicidality. The duration of individual psychotherapy ranged from six sessions to a maximum of 6 months, depending on the patient’s progress.
Consistent with the intervention’s CBT framework, individual treatment sessions typically began with rapport-building interactions focusing on the participant’s experience of the prior session, experiences during the past week, and current concerns. An agenda for the session was then set. Homework from the prior session was reviewed with an emphasis on problems and accomplishments since the previous session. During this discussion, the therapist used the participant’s experiences to reinforce previously learned concepts and to introduce new ones. The session ended with an assignment of new homework and feedback from the participant regarding the session.
The group modality was used to reinforce and extend progress made during individual therapy, provide a setting for rehearsal of new skills, foster social support, and normalize experiences and concerns related to the MI. Group members also benefited from opportunities to exchange advice and suggestions for coping with heart disease and other stressors (50). Participation in the group component of the intervention was contingent on the availability of a group within the 6-month limit of the patient’s treatment window. Other requirements included the lack of any contraindications for group participation (eg, a pattern of antisocial behavior that would harm other group members), and willingness to be involved with group participation. A participant could be enrolled into a group anytime after three individual sessions had been completed, but no later than 6 months after enrollment. Group sessions lasted for 2 hours and ran for 12 weeks. Hence, the full course of psychosocial treatment could last up to 9 months in exceptional cases. Patients could be seen in both individual and group therapy either sequentially or concurrently, depending on such factors as the availability of a group and the patient’s readiness to participate in one.
The groups were comprised of approximately five to eight participants. Members included those with depression, LPSS, or both, and the cultural diversity of the population resulted in groups comprised of members with wide ranging backgrounds. Sessions began with a 15-minute relaxation practice, followed by announcements, setting of an agenda, and discussion of homework and participants’ experiences of the past week (35–40 minutes), building on work done in individual treatment. The group then spent approximately 1 hour focusing on one of the 12 substantive topics described in the curriculum, including assertiveness training, life goals and planning, and enhanced efficacy dealing with life circumstances (Table 2). A brief review of the session’s main point, assignment of homework tasks, participant feedback, and a preview of the next session completed the session.
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TREATMENT OF DEPRESSION
The primary goal for patients with depression was to eliminate their depressive symptoms as quickly as possible, or at least reduce them to a subclinical level. The intervention helped participants develop an ability to: 1) identify the problem situations and associated cognitions that promote depressed moods; 2) apply cognitive and behavioral skills as needed in their daily life; 3) appraise their thoughts and beliefs about current problematic situations or issues; and 4) apply newly learned skills to problematic situations in the future. To monitor progress in treatment, the BDI was administered every session. Treatment continued until the participant completed at least six sessions, was in at least partial remission, had developed self-therapy skills, and scored below seven on the BDI for two consecutive assessments. For participants who met these criteria but who relapsed within 6 months of randomization, treatment was resumed. Adjunctive pharmacotherapy was also provided for patients with severe depression and for those whose response to psychotherapy was too slow. AHCPR clinical practice guidelines for treatment of depression (51) were followed, under the direction of study psychiatrists. Sertraline was selected as the initial agent (unless contraindicated), based on previous studies supporting its efficacy and safety in patients with cardiovascular disease (cf. (52). Patients unable to tolerate sertraline or judged to have an inadequate response to treatment were considered for alternative treatment, usually with another SSRI or with nortriptyline. Patients who achieved an adequate therapeutic response to the medication were continued on it for 12 months and seen by the study psychiatrist on a weekly basis for the first 3 to 5 weeks, and then at 2- to 4-week intervals as needed.
TREATING LOW PERCEIVED SOCIAL SUPPORT
The primary goal of treatment for LPSS was to alter the participant’s perception of his or her social support by modifying the environmental, behavioral and/or cognitive factors that lead to LPSS. Treatment was individually tailored on the basis of a multimodal assessment that included both qualitative and quantitative strategies (53–55). It identified the participant’s instrumental and emotional needs, and revealed his or her cognitions, attitudes, and beliefs relating to social ties and network availability. It also identified the degree of the participant’s social integration, current satisfaction with specific sources of support, and preference for, and importance to them of, specific types of support. It determined the sophistication of the participant’s social planning, communication, and problem-solving skills, and identified whether social anxiety or phobia was contributing to the experience of insufficient support. Modular intervention components were closely linked to this assessment and addressed 1) behavioral/social skill deficits, 2) cognitive factors contributing to the perception or maintenance of unsatisfying levels of social support, and 3) social outreach and network development. Inasmuch as a host of factors provide an individual with a sense of support, most cases of LPSS required an integration of these three treatment modules.
A modified form of the PSSS (56) was used to monitor progress in treatment for LPSS. Treatment continued until the participant was engaged in at least one satisfying and supportive social relationship (other than with the counselor), was able to do "self therapy," and achieved a criterion score on the modified PSSS for at least two consecutive sessions.
COUNSELORS
The ENRICHD counselors had advanced graduate training in clinical or counseling psychology (PhD, PsyD), clinical social work (LCSW), clinical psychiatry (MD), or psychiatric nursing (MS or greater). The ideal candidate had substantial previous clinical experience with CBT, including treatment of depression and work with couples, families, groups, and patients with chronic disease or, more specifically, coronary disease. The counselors underwent intensive training and certification by the Beck Institute and by ENRICHD clinical investigators in the use of CBT and in the conduct of the ENRICHD intervention. They were supervised throughout the intervention phase of the trial by experienced cognitive-behavioral therapists, most of who were ENRICHD coinvestigators. Supervision consisted of a minimum of 2 hours per week of individual and/or group sessions and included analysis of audiotapes of therapy sessions and other case materials. The supervisors themselves received supervisory training from the Beck Institute.
QUALITY ASSURANCE
Adherence to the treatment protocol was documented on standardized treatment data logs. Additionally, a set of process measures was used to track clinical progress and patient engagement, and a variety of cognitive-behavioral assessment tools (eg, dysfunctional thought records, activity logs, coping cards, and homework forms) were provided to the counselors to use as needed. All sessions (both individual and group) were audiotaped, and systematic reviews of these audiotapes and case information served as the basis of weekly, site-based supervision. Beck Institute staff audited tapes of approximately 20% of the therapy sessions. In addition, regular conference calls between ENRICHD site supervisors, ENRICHD senior clinicians, and Beck Institute staff addressed issues that arose from the study (57).
CHALLENGES IN THE DELIVERY OF THE INTERVENTION
Delivering the EHRICHD intervention posed a number of difficult challenges. These challenges were a regular source of discussion and problem-solving effort during the weekly supervision sessions conducted at each ENRICHD site, and the regular conference calls conducted with all ENRICHD site supervisors and key study and Beck Institute staff. For example, prior clinical trials of psychosocial interventions with cardiac patients had been conducted with a largely homogenous population. The ENRICHD population was, however composed of 48% women, 40% over age 60, 24% with less than 12 years of education (15% with <8 years of education), and 34% minority. Hence, effort was required to increase the acceptability of this type of treatment for a highly diverse group. This was accomplished by a number of strategies. Counselors were trained in a range of "cultural competencies," including knowledge of different groups’ life-styles, values, and customs. In addition, they developed ways to talk about and conduct the intervention in a manner that "depathologized" the treatment and the presenting factors that made the participant eligible for the trial. Discussion of treatment strategies was held without resorting to jargon, and using the participant’s own language and a range of metaphors to communicate important concepts. Lastly, they dealt with issues of low literacy, concrete thinking, and decreased capacity for abstraction by reducing the use of written material, incorporating pictorial presentations, and relying on metaphors to demonstrate key concepts.
Delivering the treatment to patients recovering from an acute MI posed a number of additional challenges. For example, in contrast to typical outpatient clinical trials of treatments for psychiatric disorders or other psychosocial problems wherein prospective participants volunteer in response to advertisements, the ENRICHD participants were actively recruited by research nurses from in-patient units while recovering from an acute MI. In addition, while hospitalized, patients were mostly preoccupied with their health and health care. Under the circumstances, many of them were either unaware of, or relatively unconcerned about, their emotional distress or lack of social support. Even patients who admitted to depression or social isolation did not necessarily believe that these problems were related to their heart disease or that they required treatment. Furthermore, for many, psychotherapy or antidepressant medications were not personally acceptable forms of treatment. This presented a particular obstacle to the recruitment process and initiation of treatment for those randomized to intervention.
The spouse or other family members of participants, although often allies in the treatment process, were sometimes found to be obstacles inasmuch as they tried to prevent the patient from participating in the study, usually out of concern that it would be too burdensome. Furthermore, the transition from hospital to home is often accompanied by a marked change in outlook. Some patients, who consented eagerly to counseling in the crisis atmosphere of hospitalization for a life-threatening emergency, changed their minds after returning home to familiar surroundings and routines.
Thus, it was often difficult to induct depressed or socially isolated patients into the ENRICHD treatment during the early stages of recovery from the acute MI. Overcoming barriers to participation in, and adherence to, the treatment protocol, therefore, became a key task for the ENRICHD counselors. To accomplish this, it was important for the counselors to present themselves to participants and their family members as useful resources in the post-MI recovery process. The counselor would often visit the participant and initiate the treatment process while the participant was still in the hospital. A particularly useful strategy was to have participants "tell their story," ie, to describe the circumstances that led up to their MI, and the circumstances they expected to face in its aftermath. The counselors, by listening in an active manner, were able to develop a therapeutic alliance, and provide the participants with a sense of being understood and cared about. This process also allowed the counselor to conduct a thorough evaluation and determine potential targets for intervention. They were then able to personalize the trial, describing it in a way that made sense to all in the context of the participant’s unique circumstances. This often included educating the participant about the complementary nature of mind and body in the maintenance of health and the development of disease. Individualized motivational strategies were also used to engage the involvement of patients who were not distressed about the psychosocial risk factors that were the targets of the intervention.
There were equally formidable barriers to the effort for rapid intervention. Many patients were too infirm to attend outpatient sessions during the first few weeks after discharge, unable to drive themselves to the clinic, or unable to find other transportation. In addition, if the patient underwent coronary artery bypass graft surgery shortly after the MI, many days would pass before he or she was able to participate in outpatient sessions. Furthermore, many patients after the MI or revascularization were discharged to rehabilitation facilities for extended stays. Hence, it was often necessary to "take the treatment to the participant," rather than waiting until the participant was able/willing to come to the treatment. This was accomplished via bedside and home visits. Indeed, in some cases the treatment was conducted almost entirely in the patient’s home or at bedside if the patient was still in a care facility. Many sessions were also conducted via telephone. This approach also was used for group sessions, to "conference in" participants who lived at great distance or were unable to make a particular session. Visits to the home and the use of telephone were indispensable for overcoming the logistical difficulties that often prevented patients from attending outpatient clinic visits. It was also important to appreciate the limitations posed by medical illness. The pace of treatment, and the goals and assignments had to be adjusted accordingly.
Another challenge posed by the trial was the need to sustain a participant’s involvement long enough to reach a successful outcome. As time went on, many patients expressed a growing desire to put the heart attack behind them and move on with their lives. This was occasionally accompanied by a complaint that the treatment program was an ongoing reminder of the MI and was therefore seen as an impediment to "moving on." In addition, environmental constraints often caused participants to feel increasingly burdened by the trial. Consequently, counselors had to be sensitive to shifts over time in the psychological meaning and therapeutic importance to the participant of the index event and the overall treatment. At times, focusing on the MI or on the risk of a recurrent cardiac event was used to motivate the patient to participate actively in therapy. At other times, shifting the focus to other circumstances of the participant’s life that provoked feelings and thoughts of depression and the sense of being unsupported was more successful. Motivational interviewing methods were also indispensable as a tool for helping maintain a participant’s involvement with the study. Offering the participant transportation to sessions helped overcome real and perceived environmental constraints. In summary, the counselor had to always be aware of, and sensitive to, issues of participant engagement.
Some participants, despite every effort, did not have the opportunity to take part in a group. This was particularly the case when a sufficiently large cohort of study participants was not available at the right time to form a group (eg, wide geographical catchment area for sites, often involving two cities in two different states). The group component of the intervention was designed with this limitation in mind. In particular, this component of the intervention relied to a great extent on a curriculum format. This allowed for the presentation of group "material" within the setting of individual sessions. Hence, participants who were not able to attend a group were however, provided the group curriculum through handouts and discussions with their individual counselors.
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SUMMARY |
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APPENDIX |
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Clinical Sites
Duke University, Durham, North Carolina. James A. Blumenthal, PhD (Principal Investigator); Peggy Arias, BS; Michael Babyak, PhD; Teri Baldewicz, PhD; John Barefoot, PhD; Julie Bennett, RN; Rob Carels, PhD; Brian Crenshaw, MD; Suzanne Curtis, RN; Lesile Davis, RN; Kenneth Fath, MD; Les Forman, MD; Alycia Hassett, MD; Sadanand B Hegde, MD; Steven H. Herman, PhD; Alan Hinderliter, MD; Parinda Khatri, PhD; William Kraus, MD; Ranga Krishnan, MB, CHB; Steve Levenberg, PhD; Daniel Mark, MD; Pamela Marz, BA; Robert McCarthy, PhD; Gary Miller, MD; Jennifer Norten, PhD; Christopher O’Connor, MD; Joseph Puma, MD; Lorraine Rutt, BA; William Sessions, MD; Ilene Siegler, PhD; Lana Watkins, PhD; Robert Waugh, MD; Redford Williams, MD; Ann Wilson; and Bosh G Zakhary, MD.
Rush Presbyterian-St. Luke’s Medical Center, Chicago, Illinois. Lynda H. Powell, PhD (Principal Investigator); James E. Calvin, MD; David C. Clark, PhD; Steven Creech, MS; Diane Downs, RN; Claudia Eaton, MS, RN; W.J. Elliott, MD; Layla Kassem, PsyD; Alice Luten, PhD; Carlos Mendes de Leon, PhD; William (Bill) S. Miles, MD; Rocio Munoz-Dunbar, MA; Paige Pfenninger, RN, BSN; Carol Rogers Pitula, PhD, RN; Susan Szeplakay, RN; John Zajecka, MD; and Joe Zander, PhD.
Stanford University, Palo Alto, California. Robert F. DeBusk, MD (Principal Investigator); Linda Balenesi, RN; Anna Casteneda; Allison Deeter; Susan Duenke, PsyD; Lynda Fisher Forseth; Erika Sivarajan Froelicher, PhD, RN, FAAN; Robin Hanna, RN; Heidi Kaiser; Sarah Lamb, RN; Simone Madan, PhD; Margaret Marnell, PhD; Nancy Houston Miller, RN, BSN; Kathleen Parker, RN, MSN; Diane Strachowski, PhD; C. Barr Taylor, MD; and Carl E. Thoresen, PhD.
The University of Alabama at Birmingham, Birmingham, Alabama. James Raczynski, PhD (Principal Investigator); Barry Adams, PsyD; Stephanie Allison, RN; Melba Bandy, RN; James Barton, RN; Larry Bates, PhD; Vera Bittner, MD; Martha Cole; Carol E. Cornell, PhD; Vicki DiLillo, PhD; Jeff Dolce, PhD; M. Janice Gilliland, MA, MSPH; Shelly Jordan, BSN; Jerry Markovitz, MD; Dehryl Mason, JD, PhD; John Shuster, MD; Patricia White, PhD; and Suzan Winders, PhD.
The University of Miami, Miami, Florida. Neil Schneiderman, PhD (Principal Investigator); Marc Gellman, PhD; Gail Ironson, MD, PhD; Kristin Kilbourn, PhD; Marta E. Manrique-Reichard, PhD; Judith Rey McCalla, PhD; Thomas Mellman, MD; Caridad V. Mendoza, RN; Robert Myerburg, MD; Elsa Velez Robinson, RN; Patrice Saab, PhD; Rafael Sequeira, MD; and Pura Teixeiro, RN.
University of Washington, Seattle, Washington. 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 (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; and Susan L. Woods, RN, PhD.
Washington University, St. Louis, Missouri. Robert M. Carney, PhD (Principal Investigator); Linda Beller, RN, MSN; Teresa Benoist, RN, BSN; Stephen Berger, PhD; Sarah Breeden, RN; Jerome D. Cohen, MD; Iris Csik, MSW; Paul R. Eisenberg, MD; Jane Finn, RN, BSN; Kenneth E. Freedland, PhD; Patricia Hoffman, PhD; Janet Meyer, RN, BSN; Angela Misuraco, RN, BSN; Michael W. Rich, MD; Stephen Ristvedt, PhD; Debbie Sitton, RN, BSN; Judith Skala, RN, MA; and Edward S. Weiss, MD.
Yale/Harvard Universities, New Haven, Connecticut and Boston, Massachusetts. Matthew M. Burg, PhD (Principal Investigator); Lisa Berkman, PhD (Co-Principal Investigator); David Abrams, PhD; Dan Beck, PhD; Paula P. Clark, RN; Susan Farber, PhD; Sandy Ginter, RN, BSN; Keith R. Gonsor, PhD; Judy Hall, RN; L. Howard Hartley, MD; Shelby Jacobs, MD; Renee Kochevar-Sukkarie, PhD; Harlan Krumholz, MD; Andrew Littman, MD; Peter Manzo, PhD; Joanne McGloin, MDiv; Thalia Metalides, RN, BSN; Sandip Mukherjee, MD; James Muller, MD; Elaine Polishuk, RN; Jane Sherwood, RN, BSN; Thomas Stewart, MD; Andrew Stohl, MD; Peter Stone, MD; Karen Wu, RN; and Stuart Zarich, MD.
Coordinating Center
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. James D. Hosking, PhD (Principal Investigator); Diana J. Cattelier, PhD; Marie J. Cowan, PhD, RN, FAAN (University of California at Los Angeles); Linda A. Hartig; Jean A. Johnson; Francis Keefe, PhD (Ohio University); Kathleen Light, PhD; Brenda M. Mauer; Aluoch Ooro, MA; David Sheps, MD (East Tennessee State University); Marston E. Youngblood, MA, MPH; and Allan S. Jaffe, MD (State University of New York, Syracuse).
ECG Core Laboratory
St. Louis University Medical Center, St. Louis, Missouri. Bernard Chaitman, MD (Principal Investigator); Therese Belgeri, RN; and Karen Stocke, BS, MBA.
Beck Institute for Cognitive Therapy, Bala Cynwyd, Pennsylvania. Judith S. Beck, PhD; Naomi Dank, PhD; Christine J. Reilly, PhD, RN; and Lesile Sokol, PhD.
Project Office
National Institutes of Health–National Heart, Lung & Blood Institute, Bethesda, Maryland.Susan M. Czajkowski, PhD (Project Officer); Robin Hill, PhD; Sally Hunsberger, PhD; Cheryl A. Jennings; Peter Kaufmann, PhD; Sarah Knox, PhD; James Norman, PhD; and Carolyn C. Voorhees, PhD.
Data Safety and Monitoring Board Members. Nanette Wenger, MD (Chair); Baruch Brody, PhD; Luther Clark, MD; James Coyne, PhD; Robert M. Kaplan, PhD; Roger Kathol, MD; and Genell Knatterud, PhD.
ENRICHD Committees
Intervention Subcommittee. Lynda H. Powell, PhD, Chairperson; James A. Blumenthal, PhD; Matthew M. Burg, PhD; Robert M. Carney, PhD; Carol E. Cornell, PhD; Marie J. Cowan, PhD, RN, FAAN; Susan M. Czajkowski, PhD; Vicki DiLillo, PhD; Erika Sivarajan Froelicher, PhD, RN, FAAN; Marc Gellman, PhD; Steven H. Herman, PhD; Robin Hill, PhD; Peter Kaufmann, PhD; Francis Keefe, PhD; Pamela Mitchell, PhD, RN; Carol Rogers Pitula, PhD, RN; Patrice Saab, PhD; Neil Schneiderman, PhD; C. Barr Taylor, MD; Carl E. Thoresen, PhD; Richard C. Veith, MD; Carolyn C. Voorhees, PhD; Redford Williams, MD; and Suzan Winders, PhD.
Pharmacology Subcommittee. C. Barr Taylor, MD, Chairperson; Matthew M. Burg, PhD; Robert M. Carney, PhD; Diana J. Cattelier, PhD; Vicki DiLillo, PhD; Les Forman, MD; Steven H. Herman, PhD; Allan S. Jaffe, MD; Peter Kaufmann, PhD; Ranga Krishnan, MB, CHB; Thomas Mellman, MD; William (Bill) S. Miles, MD; James Norman, PhD; Lynda H. Powell, PhD; John Shuster, MD; Richard C. Veith, MD; and Marston E. Youngblood, MA, MPH.
Quality Assurance Subcommittee. Marie J. Cowan, PhD, RN, FAAN; Matthew M. Burg, PhD, Co-Chairs; John Barefoot, PhD; Diana J. Cattelier, PhD; Carol E. Cornell, PhD; Kenneth E. Freedland, PhD; Robin Hill, PhD; Cheryl A. Jennings; Alice Luten, PhD; Patrice Saab, PhD; and Marston E. Youngblood, MA, MPH.
Received for publication July 20, 1999.
Revision received January 8, 2001.
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 F. Lesperance, N. Frasure-Smith, D. Koszycki, M.-A. Laliberte, L. T. van Zyl, B. Baker, J. R. Swenson, K. Ghatavi, B. L. Abramson, P. Dorian, et al. Effects of Citalopram and Interpersonal Psychotherapy on Depression in Patients With Coronary Artery Disease: The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) Trial JAMA, January 24, 2007; 297(4): 367 - 379. [Abstract] [Full Text] [PDF]
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P. J. Lustman, R. E. Clouse, B. D. Nix, K. E. Freedland, E. H. Rubin, J. B. McGill, M. M. Williams, A. J. Gelenberg, P. S. Ciechanowski, and I. B. Hirsch Sertraline for Prevention of Depression Recurrence in Diabetes Mellitus: A Randomized, Double-blind, Placebo-Controlled Trial. Arch Gen Psychiatry, May 1, 2006; 63(5): 521 - 529. [Abstract] [Full Text] [PDF]
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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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 C. Dickens, L. McGowan, C. Percival, J. Douglas, B. Tomenson, L. Cotter, A. Heagerty, and F. Creed Association Between Depressive Episode Before First Myocardial Infarction and Worse Cardiac Failure Following Infarction Psychosomatics, December 1, 2005; 46(6): 523 - 528. [Abstract] [Full Text] [PDF]
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M. M. Burg, J. Barefoot, L. Berkman, D. J. Catellier, S. Czajkowski, P. Saab, M. Huber, V. DeLillo, P. Mitchell, J. Skala, et al. Low Perceived Social Support and Post-Myocardial Infarction Prognosis in the Enhancing Recovery in Coronary Heart Disease Clinical Trial: The Effects of Treatment Psychosom Med, November 1, 2005; 67(6): 879 - 888. [Abstract] [Full Text] [PDF]
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C. B. Taylor, M. E. Youngblood, D. Catellier, R. C. Veith, R. M. Carney, M. M. Burg, P. G. Kaufmann, J. Shuster, T. Mellman, J. A. Blumenthal, et al. Effects of Antidepressant Medication on Morbidity and Mortality in Depressed Patients After Myocardial Infarction Arch Gen Psychiatry, July 1, 2005; 62(7): 792 - 798. [Abstract] [Full Text] [PDF]
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K. W. Davidson, N. Rieckmann, and M. A. Rapp Definitions and Distinctions Among Depressive Syndromes and Symptoms: Implications for a Better Understanding of the Depression-Cardiovascular Disease Association Psychosom Med, May 1, 2005; 67(Supplement_1): S6 - S9. [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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R. M. Carney, J. A. Blumenthal, K. E. Freedland, M. Youngblood, R. C. Veith, M. M. Burg, C. Cornell, P. G. Saab, P. G. Kaufmann, S. M. Czajkowski, et al. Depression and Late Mortality After Myocardial Infarction in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) Study Psychosom Med, July 1, 2004; 66(4): 466 - 474. [Abstract] [Full Text] [PDF]
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N. Schneiderman, P. G. Saab, D. J. Catellier, L. H. Powell, R. F. DeBusk, R. B. Williams, R. M. Carney, J. M. Raczynski, M. J. Cowan, L. F. Berkman, et al. Psychosocial Treatment Within Sex by Ethnicity Subgroups in the Enhancing Recovery in Coronary Heart Disease Clinical Trial Psychosom Med, July 1, 2004; 66(4): 475 - 483. [Abstract] [Full Text] [PDF]
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G. Schrader, F. Cheok, A.-L. Hordacre, and N. Guiver Predictors of Depression Three Months After Cardiac Hospitalization Psychosom Med, July 1, 2004; 66(4): 514 - 520. [Abstract] [Full Text] [PDF]
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H. S. Lett, J. A. Blumenthal, M. A. Babyak, A. Sherwood, T. Strauman, C. Robins, and M. F. Newman Depression as a Risk Factor for Coronary Artery Disease: Evidence, Mechanisms, and Treatment Psychosom Med, May 1, 2004; 66(3): 305 - 315. [Abstract] [Full Text] [PDF]
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Writing Committee for the ENRICHD Investigators 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 JAMA, June 18, 2003; 289(23): 3106 - 3116. [Abstract] [Full Text] [PDF]
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N. Frasure-Smith and F. Lesperance Depression--A Cardiac Risk Factor in Search of a Treatment JAMA, June 18, 2003; 289(23): 3171 - 3173. [Full Text] [PDF]
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 B. C. Sirois and M. M. Burg Negative Emotion and Coronary Heart Disease: A Review Behav Modif, January 1, 2003; 27(1): 83 - 102. [Abstract] [PDF]
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