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Psychosomatics 39:134-143, April 1998
© 1998 The Academy of Psychosomatic Medine

Effect of Intervention for Psychological Distress on Rehospitalization Rates in Cardiac Rehabilitation Patients

John L. Black, M.D., F.A.P.M., Thomas G. Allison, Ph.D., M.P.H., Donald E. Williams, Ph.D., Teresa A. Rummans, M.D., F.A.P.M., and Gerald T. Gau, M.D.

Received March 27, 1997; revised May 15, 1997; accepted July 11, 1997. From the Department of Psychiatry and Psychology, and the Department of Internal Medicine, Division of Cardiovascular Diseases, Mayo Clinic and Foundation, Rochester, Minnesota. Address reprint requests to Dr. Black, Department of Psychiatry and Psychology, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905.


  ABSTRACT

 
 TOP
 ABSTRACT
 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Psychosocial factors affect the development of coronary heart disease and morbidity and mortality of patients with known coronary heart disease. A prior study has shown that psychological distress in patients with known coronary heart disease increased medical and economic costs. This study examined the effects of commonly available psychological interventions offered to patients entering cardiac rehabilitation after hospitalization for angina, myocardial infarction, angioplasty, or coronary artery bypass grafting. A total of 380 patients were screened with the Symptom Checklist-90-Revised (SCL-90-R). Those with T-scores >=63 (>=91 percentile) on the General Severity Index (GSI) subscale were randomly assigned to usual care or special intervention. Special intervention included a psychiatric evaluation, plus one to seven sessions of behavioral therapy. The percentage of patients rehospitalized for cardiac symptoms within 12 months of psychological evaluation was 43% for special intervention and 40% for usual care (NS). A correction for crossover between the treatment groups resulted in a favorable trend toward intervention, with 35% of the psychologically treated patients rehospitalized vs. 48% of the untreated patients (NS). Although there was a nonsignificant reduction of the SCL-90-R's GSI T-score, the depression score was significantly reduced in the special intervention group.

Key Words: Cardiac Patients • Rehabilitation • Intervention • Distress • Rehospitalization • Coronary Heart Disease • Heart Disease • Myocardial Infarction


  DO NEGATIVE EMOTIONS PREDICT CORONARY HEART DISEASE?

 
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 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
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The role of psychosocial risk factors in the development of coronary heart disease (CHD) has been studied since Friedman and Rosenman reported that patients with "type A" behavior patterns were at high risk for cardiac disease.1 Subsequent studies have attempted to tease out the toxic factor in the type A personality. Williams et al.2 associated hostility, as measured by the Minnesota Multiphasic Personality Inventory's (MMPI) hostility (Ho) scale, with the risk of significant occlusion in coronary arteriography patients. These findings were supported by research done by Barefoot et al.3 and Shekelle et al.4 However, Maruta et al.,5 in a 25-year follow-up study of 620 general medical patients who completed the MMPI between 1962 and 1965, failed to find the MMPI's Ho scale predictive when the risk factors age and gender were considered. Other researchers have shown, in the context of large prospective studies, an association between depressed affect and hopelessness and ischemic heart disease6 and an association between anxiety and phobic anxiety and fatal CHD, especially sudden cardiac death.7,8


  DO NEGATIVE EMOTIONS PREDICT MORBIDITY AND MORTALITY IN PATIENTS WITH KNOWN CORONARY HEART DISEASE?

 
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 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
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Several studies have associated psychosocial stress with poor outcomes in patients with CHD. Frasure-Smith et al.9,10 found in their study that the patients with psychological stress, as measured by the General Health Questionnaire (GHQ) after acute myocardial infarction (AMI), had a three-fold increase in risk of cardiac mortality over 5 years and about 1.5-fold increased risk of reinfarction over the same time period. The researchers also found that depression following myocardial infarction (MI), as measured by the Diagnostic Interview Schedule, placed patients at significantly increased risk for mortality even when the impact of left-ventricular dysfunction and previous MI were considered. Williams et al.11 measured the impact of poor economic resources and social isolation in medically treated patients with stenosis 75% or greater in at least 1 major coronary artery and found that these 2 factors significantly decreased survival rates. Goodman et al.12 found that high total potential for hostility ratings, as measured by the Type A Structured Interview, predicted risk of restenosis and number of arteries restenosed in patients undergoing single- or multiple-artery percutaneous transluminal coronary angioplasty (PTCA). Allison et al.13 found that a SCL-90-R's GSI T-score >=63 (>=91 percentile) placed patients at increased risk for cardiovascular rehospitalization during a 6-month follow-up period after hospitalization for CHD. The mean rehospitalization costs were significantly higher in the distressed patients than in the nondistressed patients ($9,504 vs. $2,146).


  DOES INTERVENTION FOR PSYCHOLOGICAL DISTRESS REDUCE MORBIDITY AND MORTALITY IN PATIENTS WITH CHD?

 
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 ABSTRACT
 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Friedman et al.14 attempted to modify type A behavior in 1,300 AMI patients, of which 983 patients were studied and followed for 4.5 years. The patients received either cardiac counseling, cardiac counseling with type A counseling, or usual care. Those patients receiving cardiac counseling with type A counseling had a significant reduction in recurrence (recurrent MI or cardiovascular death). Frasure-Smith et al.15 studied patients with AMI by using the GHQ and followed the patients for 5 years. The patients with non-Q-wave AMIs and psychological stress were found to have a significantly increased risk for cardiac mortality. However, when the stressed non-Q-wave AMI patients received intervention for psychological distress, the group did not experience an increase in risk of mortality.

Linden et al.16 performed a meta-analysis of 23 randomized control trials that evaluated the impact of psychosocial treatment on rehabilitation from documented CHD and found that the patients who did not receive psychosocial treatment showed a greater mortality and cardiac recurrence rate during the first 2 years of follow-up, with log-adjusted odds ratios of 1.7 for cardiac mortality and 1.84 for recurrence, leading the author to conclude that the addition of psychosocial treatments to standard cardiac-rehabilitation regimens reduces morbidity and mortality, psychological distress, and some biological risk factors.

Prior studies have generally set up specialized intervention programs that were attended by groups of patients who had been recruited from large medical centers. There was little consistency across studies in the identification of patients at risk or the specifics of the intervention. In addition, the model used in most studies would not be applicable to the routine clinical setting, especially in smaller communities. The purpose of this study, therefore, was to evaluate the effects of commonly available psychological interventions offered to patients entering cardiac rehabilitation after hospitalization for angina, MI, angioplasty, or coronary artery bypass grafting (CABG). Our goal was to determine if an individualized psychological intervention performed by clinically available mental health professionals would have a beneficial effect on rehospitalization rates in psychologically distressed patients in follow-up, compared with our prior study that showed rehospitalization rates and costs were higher for the distressed patients.13


  METHODS

 
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 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
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 RESULTS
 DISCUSSION
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Patient Selection
Patients were recruited from consecutive patients referred to cardiac rehabilitation. The patients were approached for consent during their second visit to the cardiac-rehabilitation center (median=24 days after index cardiac event). Inclusion criteria were as follows: 1) coronary artery disease documented by cardiac catheterization or MI; 2) hospitalization for a coronary event such as unstable angina, AMI, PTCA, or CABG surgery within 3 months of referral into cardiac rehabilitation (patients with combined coronary and noncoronary events, e.g., CABG plus aortic-valve replacement were also considered eligible); and 3) willingness to be screened and give informed consent to participate in randomization to special intervention or usual care. Patients were excluded from the study if they failed to meet any of these criteria or were >80 years of age, judged to be mentally incompetent, or currently undergoing treatment by a psychiatrist or psychologist.

When the patients were referred to cardiac rehabilitation, they were asked to complete the SCL-90-R.17 This 90-item questionnaire consists of multiple-choice questions with a 5-point (0–4) scale for distress, ranging from "not-at-all" to "extremely" distressed. The primary purpose of the SCL-90-R is to measure general psychologic distress, but specific symptoms are also classified. Responses are transformed into nine individual symptom scales or dimensions (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism) and three global measures. The GSI represents overall psychological distress and is a product of both the number of positive symptoms and their severity. On each scale, results are expressed as T-scores, with a mean of 50 and a standard deviation of 10.

Norms for both psychiatric and adult normal populations are available for the SCL-90-R; the latter were used for scoring the patient population in this study. The SCL-90-R was chosen because of the relatively brief time needed to complete the questionnaire (15–20 minutes), good acceptance by the patients, established norms, and published studies that have validated its use in cardiac patients.13,17 The cut-off of a GSI T-score >=63 (>=91 percentile) is for the normal distribution sample, not a psychiatric sample. Thus, a GSI >63 does not necessarily signify psychiatric disease states. A GSI T-score >=63 was also used because our prior study showed these patients to be at high risk for rehospitalization after an index cardiac event.13 The patients with GSI T-scores >=63 were randomized to either usual care (UC) or special intervention (SI). Those patients with GSI T-scores <63 were considered psychologically not distressed and simply followed for comparison.

Usual Care
The patients in the UC group received cardiac rehabilitation involving monitored exercise sessions one to three times per week based upon travel distance and availability of transportation. Exercise procedures were conducted according to the American Association of Cardiovascular and Pulmonary Rehabilitation Guidelines.18 Daily home exercise was also prescribed. The patients also were offered a series of educational lectures, which included information about type A behavior and stress management, a two-part support group meeting for patients and spouses or significant others, and individualized dietary counseling. The total cardiac-rehabilitation program length was about 8 weeks. At the end of the rehabilitation program, each patient underwent exercise testing and assessment of blood lipids, then received individualized counseling to establish an ongoing home-exercise program and to intensify risk-factor reduction strategies as necessary. The patients were seen again at about 3, 6, 9, and 21 months after the program ended. At that time, a blood-lipid recheck; monitored exercise sessions (at 3 and 9 months) or repeat exercise tests (at 6 and 21 months); and review of home exercise, diet, and other risk factors were performed. Lipid-lowering agents may have been added at any visit under the advice of a cardiologist. Other medication changes in response to a patient's complaints or obvious change in symptoms were coordinated through the patient's cardiologist. Cardiac rehabilitation follow-up did not take the place of regular medical follow-up by each patient's cardiologist. Generally, the patients were seen at least once by their cardiologist during the active phase of the cardiac rehabilitation and had additional medical follow-up as needed. The patients receiving UC were not prohibited from being referred to a psychiatrist or psychologist by their cardiologist or primary care physician if this was felt to be necessary.

Special Intervention
The patients randomized to SI were first seen by a board-certified psychiatrist for evaluation of the source of their psychological distress to assess the need for medical therapy for psychological distress, and to clear them for further involvement in the SI program. A semistructured, rater-administered, computerized interview based on DSM-III-R (D-Tree, American Psychiatric Press, Washington, DC) was used with most patients.

While the intent of the SI was to treat patients according to a counseling model, psychoactive drugs that were considered essential were prescribed accordingly. A total of one to seven weekly sessions were then scheduled with a clinical behavioral psychologist to deal with issues identified in the treatment plan. Intervention included 1 or more of the following: 1) individualized relaxation training; 2) stress management; 3) efforts to reduce behavioral risk factors; 4) efforts to improve compliance with medical, dietary, and exercise regiments; and 5) cognitive-behavioral interventions for identified sources of distress, such as anxiety, depression, hostility.

Data Collection
Data were collected at the following 6 time points: program entry; program exit; and 3-, 6-, 9-, and 21-month follow-up visits. Data were collected by means of an intake interview, review of medical record by the study coordinator, and by specific physiologic testing. The SCL-90-R was repeated at the 6-month follow-up visit only. Because these patients were getting all of their cardiac care at the Mayo Clinic over the time course of the study, it was possible to accurately track all rehospitalizations. The patients who failed to keep scheduled appointments were tracked through review of their medical records and phone interviews.

Statistical Considerations
A two-way analysis of variance was used to test differences in changes in each of the 9 individual symptom scales and 3 global distress scales on the SCL-90-R from program entry to program exit between the groups receiving UC and SI. Each cardiac rehospitalization was reviewed by a designated cardiologist and classified as to whether either of the following occurred: 1) "hard" event, including MI, cardiac arrest, sudden cardiac death; or 2) "cardiac" event, including hard event, PTCA, CABG, or congestive heart failure. The association of 12-month rehospitalization and hard-event vs. cardiac-event rates with the experimental group was tested by means of Pearson's chi-square analysis. Sample size was based on an expected 80% power to achieve a 25% reduction in rehospitalization rates.


  RESULTS

 
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 ABSTRACT
 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
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A total of 396 rehabilitation referrals were made over the time course of the study; 380 patients agreed to participate in the study (13 men and 3 women refused to participate). The SCL-90-R GSI score revealed 60 patients positive with GSI T-score >=63. Thirty patients were randomized each to UC and SI. The average age of the subjects was 60.2±10.7 years. Most (88%) of the patients were men. There were no statistically significant differences between the experimental groups in terms of scores on the SCL-90-R subscales, age, lipid profiles, smoking history at index event, diabetes, hypertension, family history of CHD before age 50, use of antilipidemics, anticoagulants (including aspirin), and beta-blockers (before or after MI), number of rehabilitation-exercise sessions per week, educational level, marital status, or such cardiac factors as type of index event, number of diseased vessels, or left-ventricular ejection fraction. The patients completed the SCL-90-R within 23±21 days of discharge from the index hospitalization.

Of the 60 patients with GSI T-score >=63, 11 had prior psychiatric diagnoses. None was receiving active psychiatric treatment at study entry. Upon psychiatric assessment, medications were used relatively infrequently. A total of eight patients received psychotropic medication (three in the SI group and five in UC group). The medications used included sertraline (four patients, including one patient in combination with trazodone and one in combination with lorazepam); fluoxetine (one patient); trazodone alone (two patients); and chlordiazepoxide (one patient). Psychological treatment in the SI group consisted of a single session for 10 patients, 2 sessions for 6 patients, 3 sessions for 6 patients, 5 sessions for 1 patient, 6 sessions for 1 patient, 7 sessions for 1 patient, and 0 sessions for 5 patients. In the UC group, 6 patients received some form of psychological treatment: 3 had 1 session, 1 had 4 sessions, 1 had 7 sessions, and 1 had 18 sessions. Thirty percent (n=18) and 42% (n=25) of the patients with positive SCL-90-R GSI scores were rehospitalized at 6 and 12 months, respectively, postscreening. In the first 12 months after screening with the SCL-90-R, 13 (43%) patients in the SI group were rehospitalized for cardiac symptoms a total of 23 times, whereas 12 (40%) patients in UC were rehospitalized for cardiac symptoms a total of 25 times. Figure 1 shows the cumulative percentage of the patients rehospitalized within 12 months of completing the SCL-90-R by the experimental group. Differences between the groups were not significant at 6 and 12 months. Figure 2 compares rehospitalization between the groups by event type. Figures 1 and 2 do not correct for crossover of patients from 1 treatment group to another.



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FIGURE 1. Cumulative cardiac rehospitalization rate by randomization group during first-year post Symptom Checklist-90-Revised administration





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FIGURE 2. 12-month rates of any cardiac rehospitalization, new cardiac event (myocardial infarction [MI], cardiac death, out-of-hospital cardiac arrest, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, congestive heart failure), and new hard event (MI, cardiac death, out-of-hospital cardiac arrest) by randomization group



The decrease in GSI and depression scores on the SCL-90-R from initial to 6-month follow-up are displayed in Figure 3. The decrease in the GSI scores was not significant, but the decrease in the depression score was significant (P<0.034).



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FIGURE 3. Change in General Severity Index and depression subscale scores from initial to 6-month assessment by randomization group.Note: Values displayed are mean ± standard error. aDifference between usual care and special intervention: significant at P<0.034.



A total of five patients in the SI group refused or failed to keep appointments for psychological interviews and treatment despite initially agreeing to participate. In the UC group, six patients received psychological intervention upon referral by their cardiologist or primary care physician. Of these six, none was rehospitalized for cardiac symptoms, whereas three of the five patients randomized to SI who received no treatment were rehospitalized for cardiac symptoms. Because of the large number of crossovers, rehospitalization data were re-analyzed by treatment status independent of experimental group. Figure 4 shows the percentage of patients rehospitalized and the percentage with new cardiac and hard events within 12 months of screening corrected for crossover. None of the event rates was different between the treatment and no-treatment patients.



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FIGURE 4. 12-month rates of any cardiac rehospitalization, new cardiac event (myocardial infaction [MI], cardiac death, out-of-hospital cardiac arrest, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, congestive heart failure), and new hard event (MI, cardiac death, out-of-hospital cardiac arrest) by whether or not patients received psychological treatment, independent of randomization group




  DISCUSSION

 
 TOP
 ABSTRACT
 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Past studies have shown that patients with an SCL-90-R GSI T-score >=63 are at high risk for cardiac rehospitalization within 6 months of an index event.13 This finding was again true, as 30% of the patients with a positive SCL-90-R GSI score were rehospitalized for cardiac symptoms by 6 months and 42% rehospitalized by 12 months postscreening. In this study, intervention did not significantly reduce the GSI score but did significantly reduce scores on the depression subscale (Figure 3). However, intervention failed to reduce the risk of rehospitalization even when corrected for crossover of patients from 1 group to another (Figure 4).

Reasons for the inability of the SI to reduce the 12-month cardiac rehospitalization rate include several possibilities. First, there seemed to be limited acceptance of the counseling and other psychological treatments offered. Fewer than 50% of the patients in the SI group received more than 1 counseling session. The principal reason given by patients was that they had too many other medical appointments, including cardiac-rehabilitation classes, follow-up with their cardiologist, and returns to see their primary care physician. Thus, our results may differ from prior studies,14,15 and many of the studies included in the meta-analysis were done by Linden et al.16 because we did not strongly encourage compliance with the treatment program by design. Appointments were made as convenient as possible for patients, but the cardiac-rehabilitation staff did not specifically encourage the patients to keep appointments, as staff were kept blinded to randomization status to prevent possible bias in their treatment of patients within the rehabilitation classes.

A second possibility was the lack of aggressive use of psychotropic medications in the SI group, again by design. Only three patients were treated with medications in the SI group. It is difficult to tell whether psychotropic medications were used on an as-needed basis in prior studies, thus affecting those outcomes. However, a recent, much larger multicenter, randomized trial also failed to show a significant effect of a program of psychological counseling without medication on 12-month clinical status, morbidity, or mortality in post-MI patients.19

Third, our cardiac rehabilitation program includes a good deal of the type of stress counseling that was apparently offered in the psychological intervention studies analyzed by Linden et al.16 This factor raises the possibility that the difference between SI and UC in our patients was difficult to detect because our patients were already receiving considerable education and cognitive-behavioral intervention from merely being involved in cardiac rehabilitation. Alternatively, it is possible that psychological intervention, as we delivered it, or as our patients used it, is ineffective in improving outcome.

Fourth, it is possible that the SCL-90-R was not an adequate tool for identifying at-risk patients who could respond to special intervention. However, this seems unlikely because our prior study showed that the patients with elevated SCL-90-R GSI scores were at risk for rehospitalization after an index cardiac event.13 In addition, factors such as psychological distress have been shown to be independently associated with total mortality and cardiac death in patients with known cardiac disease, and intervention for psychological distress has been shown to decrease mortality after MI, as discussed by the other researchers cited before.9,15,20,21 The SCL-90-R in general and the GSI specifically, have been shown to be appropriate for measuring distress.13,14 However, no research has been done to prove that the SCL-90-R can predict patient responsiveness to the therapies we offered.

A fifth possible reason that the SI did not reduce rehospitalization, compared with UC, was the relatively large (20%) number of crossovers to treatment from the UC group. In addition, these crossovers were treated aggressively, with 5 of 6 patients receiving psychotropic medications and 1 patient with 18 sessions of psychological treatment. While the numbers are too small to draw conclusions, it is interesting to note that none of the 6 crossovers from UC to treatment was rehospitalized for cardiac symptoms in the first 12 months postscreening, whereas 3 of 5 noncompliers in the SI group were rehospitalized. There may have been a large number of crossovers because patients and medical personnel were sensitized to the possibility that negative emotions have an adverse effect on cardiac patients who knew that this study was ongoing, thus causing distressed patients to ask for psychological intervention or for the patients' physicians to offer it. If so, this may be a positive trend indicating that once educated about the risk of negative emotions on outcome, patients may seek, and medical personnel may offer, mental health services with beneficial effects. Finally, taking all these factors into consideration, it is possible that the sample size of the study was too small to test the hypothesis.

We conclude that in our sample, SI did not cause differences in rehospitalization rates between the distressed cardiac patients receiving UC vs. SI, although the patients showed a significant reduction in the SCL-90-R depression T-score. Possible reasons for this were 1) limited acceptance of the SI arm of the study by patients; 2) conservative use of psychotropic drugs in the SI group; 3) the fact that cognitive-behavioral intervention was already part of the cardiac rehabilitation that the UC patients received; 4) the possibility that psychological intervention, as we offered it, or as patients used it, was ineffective; 5) the number of patients that crossed over from 1 treatment group to another was large, thus decreasing sensitivity of the study to detect differences between the UC and SI groups; 6) the SCL-90-R may not have been a good instrument to predict those patients responsive to the psychological intervention administered; and 7) the possibility that the number of patients was too small to effectively study the hypothesis. Interestingly, when corrected for crossover between the treatment groups, there was a trend for the patients who received psychiatric or cognitive-behavioral intervention to have fewer new hard events and cardiac rehospitalizations. We recommend that additional studies be done to determine the minimum amount of cognitive-behavioral intervention required to affect hospitalization rates of CHD patients. Furthermore, studies should be done that use pharmacological approaches to determine if these types of interventions may reduce morbidity and mortality in this patient group.


  REFERENCES

 
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 ABSTRACT
 DO NEGATIVE EMOTIONS PREDICT...
 DO NEGATIVE EMOTIONS PREDICT...
 DOES INTERVENTION FOR...
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

  1. Friedman M, Rosenman RH: Association of specific overt behavior pattern with blood and cardiovascular findings. JAMA 1959; 169:1286–1296
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