Despite seemingly adequate drug treatment and control of traditional cardiovascular risk factors in women with ischemic heart disease (IHD) in recent years,1,2 there has been much less improvement in survival in women with severe IHD than in men.3,4 Women now have a worse short-term5–7 as well as long-term8 outcome than men after an acute myocardial infarction (AMI), even after adjusting for clinical covariates, and younger women seem to be most vulnerable. A secondary prevention strategy complementary to drug treatment and conventional lifestyle advice is psychosocial intervention. Beneficial effects of such intervention programs have been reported.9,10 Effective psychosocial interventions contain elements of mediating knowledge, group support, and stress management.11,12 However, Frasure-Smith et al13 reported higher cardiac and all-cause mortality in their female subjects when compared with the controls, although reanalyses of the data14 showed that there was a group of women that had benefited from their program. Also, the ENRICHD Investigators found a possibly less beneficial effect on all-cause mortality and recurrent MI in the women in their treatment group.15
After an AMI, women are more likely than men to be depressed, anxious,16 and exhausted.17 Post-AMI women are also more limited in social17 and emotional functioning, less satisfied with their current life situation, and report worse perceived health, regardless of age and severity of disease.18 Psychosocial factors like depression,19,20 vital exhaustion,21,22 stress,23 low socioeconomic status,24 and lack of social support25 are also recognized as risk factors for first and/or recurrent cardiac events.
Most of the early studies have included only, or mostly, men with IHD.26 Men and women have seldom been treated and analyzed separately or compared with each other.25 Previous evaluations of gender-mixed programs have shown that women are less likely to participate in cardiac rehabilitation programs than men. They show lower attendance rates and greater dropout rates from conventional lifestyle intervention programs.16,17,27 However, when women do participate in cardiac rehabilitation, they have similar or better improvements in functional capacity with physical training,28 as well as in lifestyle changes and psychosocial measures.10,29
These gender differences in attendance and clinical and psychosocial patterns possibly contribute to the fact that women seem to have benefited less than men from rehabilitation programs. The aim of the present randomized treatment study was to evaluate a 1-year group-based cognitive-behavioral stress management program designed specifically for women with IHD. We adopted a broad concept of stress management aimed at reducing impatience and irritation, depression, anxiety, and fatigue, and improving self-esteem and quality of life. Prespecified primary endpoints were self-rated stress behavior, vital exhaustion, depressive mood, and quality of life.
SUBJECTS AND METHODS
Eligible women for the Women's Hearts trial were identified from hospital discharge registers. Inclusion criteria were a woman younger than 80 years, living in the county of Västerbotten, Sweden, who from 1996 onwards had had a first or recurrent AMI, or had been subjected to coronary angioplasty or coronary artery bypass graft (CABG) surgery, or had angina pectoris with coronary artery disease confirmed by angiography and treated noninvasively, and had given informed consent. Exclusion criteria were (a) AMI, coronary angioplasty, or CABG surgery within the past 4 months (these women could be enrolled later), (b) unstable coronary artery disease with a planned invasive investigation or treatment, (c) any disease that could interfere with the participation in the trial or otherwise interfere with the therapy (eg, malignancy or psychiatric disease [except depressive mood]), (d) non–Swedish-speaking, (e) other apparent obstacles, for example, of social character, making it difficult to participate in regular group activities (eg, alcohol or drug abuse, inability to leave home or work), and (f) participation in another treatment study. Eligible women were contacted in writing, by telephone calls, and sometimes by personal contacts. The diagnosis of AMI was confirmed by symptoms, electrocardiogram, and/or cardiac enzymes. In uncertain cases, an independent cardiologist evaluated the hospital discharge diagnosis.
We used a prospective, randomized trial design. The women were enrolled and randomized during the years 1997–2001 to either 1-year cognitive-behavioral stress management intervention or usual care (UC) (trial profile, Fig 1). Randomization was by sealed envelopes, stratified by place of living into 3 geographical areas. A follow-up was conducted 1 year after inclusion, when the intervention program was concluded, with the last patients concluding treatment on May 31, 2002. Prespecified primary outcome variables were self-rated stress behavior, vital exhaustion, depressive mood, and quality of life. The study protocol also included a number of secondary outcome variables as well as follow-ups 2 and 5 years after inclusion (not reported in the present article). The Women's Hearts study was approved by the Research Ethics Committee of Umeå University.
Women assigned to the UC group received usual care and follow-up for women with IHD, including outpatient visits to cardiologists and cardiology nurses. Specifically for the present trial, before randomization, all patients underwent 1 week of psychometric and laboratory testing during which they also received general lifestyle advice concerning diet, physical training, and smoking cessation. During this week, the women got a 1-hour lecture about type-A behavior and stress. They were informed about and introduced to relaxation practices, as well as relaxing qigong-type exercises. Stress reactions and stress prevention were briefly mentioned during the lectures of physiology (with emphasis on IHD) and physical exercise.
All women answered the self-administered psychosocial instruments and a questionnaire concerning demographic and lifestyle factors, both at inclusion and at the follow-up. At the follow-up, they also reported hospital contacts, if any.
Patients entered the program 4 to 10 months after the coronary or diagnostic event. Each treatment group consisted of 5 to 9 participants. The program composed of 20 two-hour sessions over the course of 1 year. Sessions were held weekly for the first 10 weeks. All groups were treated by the same leader, especially educated for this purpose.
There were 5 key components of the program with specific goals (for a more detailed description of the program, see reference 12):
Education: To develop knowledge about basic anatomy and physiology of the cardiovascular system; manifestations of and treatment procedures for IHD; symptoms and signs of different stress reactions; and the relationship between stress and IHD.
Self-monitoring: To become more alert to bodily signals such as muscular tension, heart rate, and pain; noticing behavioral and cognitive cues; observing, reflecting, and drawing conclusions about contingencies of behavior.
Skills training: To reduce negative affect by learning to express thoughts and emotions directly, honestly, and in a caring manner; and learning to act, rather than merely react, to everyday problems of living.
Cognitive restructuring: Can be summarized as the development of self-talk to enhance self-respect and self-esteem; the ability to cope with the unexpected; tolerance, acceptance, and respect for people different from oneself; trust in others; and positive emotions such as joy, enthusiasm, curiosity, optimism, and love.
Spiritual development: A discussion of spiritual and life values to create a balance between work, family, health, pleasurable activities, spiritual interests; finding new interests; developing joy, enthusiasm, and hope; accepting and giving love.
The structure of the program is similar to most cognitive-behavioral treatment programs. We want to emphasize 2 aspects in particular that are related to the profiling of this program to women.
Within the structure of the program, the specific contents and themes were tailored to women's typical daily life experiences. The examples from and applications to daily life experiences were solicited through self-monitoring diaries. For the women, they were most often related to home, family, and household. Many men may not show much empathy with and understanding of such worries. Some examples: self-monitoring was often focused on fears, anxieties, and guilt feelings in relation to relationship burdens. Social network is almost invariably positive for men, but for women it might entail demands, perceived shortcomings, and worries.23 Therefore, the social network may demand her support but not provide it reciprocally. Skills training for women in this group needs to focus on self-confidence and self-assertion—speak out more—while in contrast, many men with IHD in similar groups need to develop skills to be less aggressively assertive—speak out less—and be more intimate and trusting.
The second major reason for single-gender groups is group dynamics. Many men are more socially dominant than many women, and gender roles create communication patterns where women tend to supportively listen to others. In gender-mixed cardiac stress management groups, women are often relatively fewer in number, a bit older than the men, and exhibit less self-confidence in social situations. Therefore, they may be reluctant to express their own opinions and feelings. This is precisely captured by the quotation of one cardiologist, “But isn't it nice for the men in the group if there are women present?”
Self-rated stress behavior and reactions was assessed by a self-rating instrument (The Everyday Life Stress scale) developed by the research group for use in behavioral modification trials in subjects with cardiovascular disease.12,30 This instrument does not assess stressors, but rather the subjective response to stressors, mainly other people's behavior. The reason for including this instrument is that many cardiac patients are excessively reactive to and frustrated by minor “inadequate” behaviors in other people. Such easily triggered reactivity may be linked to increased burden on the cardiovascular system.31 Twenty statements on a 4-point scale (0–3) refer to self-rated stress behavior in everyday life situations and are connected to either time urgency/impatience or easily aroused irritation/hostility. Thus, the score ranges between 0 and 60 points, with higher scores indicating more self-rated stress behavior. “I feel time urgent,” “I strongly dislike waiting in lines,” “I get irritated when others are fumbling or negligent,” and “People tell me to relax and calm down” are examples of statements in the instrument. The internal consistency between the 20 items is high (Cronbach's α = .90). Test-retest reliability was tested in 2 groups, one comprising 33 hospital staff and office workers, the other group of 38 patients aged 28 to 71 years, most of them with cardiovascular disorders, undergoing a lifestyle intervention program. The Spearman correlation coefficient was high in both groups, 0.88 and 0.90, respectively.
Vital exhaustion was measured by the Maastricht Questionnaire,32 used earlier in a similar study.21 The subjects responded to each of 21 statements on a 3-point scale (0–2), with a maximal total score of 42 after reversing responses to the same direction of exhaustion. Higher scores indicate more vital exhaustion. The first 59 women to participate in Women's Hearts received a slightly different 19-item questionnaire at inclusion. To obtain a score based on 21 items, we calculated the individual's mean from the 19 items after imputing missing items, and multiplied by 21. Of these 59 women, 48 remained at the follow-up.
Depressive mood was assessed by the 9-item depression subscale from the Comprehensive Psychopathological Rating Scale Self-Affective (CPRS-S-A), a self-rating scale derived from the Comprehensive Psychopathological Rating Scale (CPRS).33,34 CPRS is used to measure depression, anxiety, and compulsive behavior.33–35 The CPRS-S-A depression subscale uses a 7-point scale (0–3 with half-point steps), with a maximum score of 27 indicating the highest degree of depressive mood. Scores of 6 points and above are indicative of depression.34
Quality of life was measured using 3 scales. This instrument, Quality of Life,36,37 was used in a previous Swedish study of subjects with cardiovascular disease.38 It has also been used in the POST CABG Biobehavioral Study, which evaluates quality of life in patients undergoing CABG surgery.39 Patients are asked to rate the quality of life on a scale (“Ladder of Life”), and the assessment is done for the present situation, 1 year ago, and 1 year ahead from now. In the present trial, the scale assessing the current quality of life was used. The score for each scale ranges between 0 and 9 points, with the highest score indicating the best quality of life possible.
To adjust for missing responses in single items in the psychosocial instruments, we imputed scores using values obtained in the UC group (see below). If there was more than one mode, we used the median value. The proportion of imputed items was less than 0.1% for all psychosocial endpoints, both at baseline and follow-up.
Reference values used in Figure 2 for self-rated stress behavior, vital exhaustion, and quality of life were collected within the framework of the Northern Sweden Collaborating Centre of the World Health Organization (WHO) Monitoring of Trends and Determinants of Cardiovascular Disease (MONICA) project, described in detail elsewhere.40 The data, used in an earlier study by this study group,1 originated from 206 MONICA women without severe vascular disease, who were 45 years or older and living in the same geographical area as the present study subjects.
Sample size estimations were based on what were estimated to be clinically important differences in the psychosocial outcome measures. Assuming a standard deviation of 20% of the range of the psychosocial scores, a power of 0.80, and a P of .05, the number of patients needed ranged by psychosocial variable from 41 to 91 per group. Allowing for a dropout rate of 25% or less, the trial was designed to randomize a total of 200 patients.
To determine possible covariates with respect to the outcome variables a number of variables (Table 1) were tested to detect possible differences at baseline between the intervention and UC groups by using the χ2 or Fisher's Exact test when categorical variables, the T test when data of normal distribution, and the nonparametric Mann-Whitney test when not normally distributed (continuous or ordinal variables) data. To explore the outcome variables and possible differences between the intervention and UC groups at baseline, the T test and the nonparametric Mann-Whitney test were used. The developments from baseline to follow-up in the 2 groups were investigated by analyses of variance with repeated measures procedure. The variable for group assignment (intervention or UC) was included in the models, as was an interaction term (Group × Time of Assessment), to detect different magnitude of change of the outcomes between the intervention and UC groups. Separate models were built for each of the 4 outcome variables. To investigate eventual effects of age and to be able to control for age, an age variable was included as well. Finally, a term for interaction between age-group and group-assignment was included in the models to test whether age modified the treatment effects. Data transformations were done to obtain data that fitted the normal distribution, when necessary. If normality assumption was still uncertain, additional nonparametric tests were used to confirm results yielded by means of analysis of variance. The analyses were carried out using the statistical computer program SPSS v.11.0.
Out of the 255 women who were identified as eligible (Fig 1), 198 agreed to participate (mean age = 61 years, range = 35–77 years). Fifty-seven women (22.4%) with a mean age of 67 years (range = 41–78 years) declined to participate. Compared to the 198 participating women, they were significantly older (P < .001). The 3 most common reasons given for their decisions were long distance to the study site (including unwillingness to stay at a hotel), feelings of too poor health, and lack of interest in group treatment.
One hundred one women (51%) were randomized to the 1-year stress management intervention and the other 97 (49%) to the UC follow-up. A total of 27 women (13.6%, mean age = 62 years), 18 from the intervention group and 9 from the UC group, withdrew from the study after being randomized. In the intervention group, 8 women stated low motivation as their reason for withdrawal, 2 were unwilling to participate in a group, 2 stated economic reasons, 2 stated lack of time, 1 felt too ill, 1 could not leave home, 1 had not enough knowledge of the Swedish language, and 1 woman did not give her reason. In the UC group, 2 had planned journeys, 1 woman stated low motivation, 1 felt too ill, 1 could not leave home, 1 had onset of dementia, 1 experienced a distressing separation from her husband, 1 was dissatisfied with the conventional follow-up, and 1 did not give any reason. Also, 3 women who had completed the intervention and 2 women from the UC group did not find the time for the follow-up questionnaires and laboratory tests but wanted to stay in the study for the future follow-ups. Thus, a total of 32 women with a mean age of 61 years did not complete the whole follow-up, leaving 80 women in the intervention group and 86 women in the UC group for this study.
Characteristics at Randomization
Table 1 shows the characteristics at baseline in the intervention and UC groups. There was significantly younger age in the intervention group (mean age = 59 years, range = 37–77), as compared with the UC group (mean age = 62 years, range = 35–76) (P < .036). The 2 groups had similar body mass index and level of education, and a majority of the women in both groups exercised on a regular basis. More than 8 out of 10 were postmenopausal, and the manifestations of IHD and its treatment, including drug therapy, were similar in the 2 groups except for the use of β-blockers, which were more common in the UC group (P < .034). When comparing the 27 subjects who withdrew from the study with those remaining concerning the variables presented in Table 1, there were no significant differences (data not presented).
Major Adverse Cardiovascular Events and Deaths
During the year, a total of 28 women, 15 from the intervention group and 13 from the UC group, were admitted to hospital because of major adverse cardiovascular events. Of these, 2 women from the intervention group and 1 from the UC group had had an AMI, 1 woman from each group had been subjected to a coronary artery intervention, and 12 and 11 women, respectively, had experienced angina pectoris and/or other IHD-related symptoms. Also, 1 woman from each group had had a stroke.
There were no deaths during the study period in the 198 initially randomized women. Of those who declined to participate, 3 women had died.
Out of the 83 women completing the treatment, 59 women (71%) attended 16 to 20 group sessions out of 20, 23 women (28 %) attended 11 to 15 sessions, and 1 woman (1%) attended 9 sessions. The average participant attended 17 group sessions (83% of all sessions).
Data on the 4 primary outcome variables—self-rated stress behavior, vital exhaustion, depressive mood, and quality of life—were not available at the 1-year follow-up for the 27 women who withdrew during the trial. Since it was not possible to perform intention-to-treat analyses, explanatory (per protocol) analyse41 (including only women who were followed up at 1 year) are presented. All analyses were made after the imputation procedures, since the total scores for the individuals with one or more missing answers would have been falsely low.
Cross-sectional, univariate analyses at baseline for all 4 outcome variables showed no difference between the intervention and UC groups (all P nonsignificant). Changes in the psychosocial variables from baseline to the follow-up are illustrated in Figure 2. The intervention group showed a significantly greater reduction of self-rated stress behavior than the UC group (P = .006, analysis of variance with repeated measures procedure). The vital exhaustion scores also dropped significantly more for the intervention group (P = .03). Both groups showed less depressive mood and an increased quality of life over time; however, between-group differences did not reach statistical significance.
Multivariate models were built for each of the 4 psychosocial outcome variables, and next an interaction term, “group x age,” was included in the models, but age was not found to modify the effect of, or interact with, the intervention.
This is the first trial to evaluate a cognitive-behavioral stress management program designed specifically for women with IHD. Our results show that such a program, conducted over a period of 1 year, in some aspects improves psychological well-being in women with IHD. Their levels of self-rated stress behavior and vital exhaustion were reduced. They showed less signs of depression, but there were also some improvements in the UC group so that the rate of recovery did not reach statistical significance when comparing the groups. Finally, the women in the intervention group experienced an enhanced quality of life that was of a larger magnitude, although not significantly so when compared with women in the UC group.
The excess fatigue, hopelessness, listlessness, loss of libido, increased irritability, and problems with sleep are complaints that reflect the state of vital exhaustion. Most, if not all, of these feelings are also characteristic for a depressive disorder. However, a depressive mood is not a common complaint among vitally exhausted subjects.42 Although the syndromes overlap, the distinctive characteristic of vital exhaustion is fatigue, and depressive symptoms may be secondary to that. On the other hand, the primary characteristic of depressive disorder is loss of positive emotionality, which is an affective symptom. It has been shown that depressive symptoms and vital exhaustion, although strongly correlated, are differentially related to behavioral risk factors for coronary artery disease.43 Our treatment format might be better in targeting vital exhaustion than a depressive mood. Another explanation for the successful decrease in vital exhaustion in the intervention group, but the nonsignificant decrease in depressive mood, might be a spontaneous improvement in both groups. A spontaneous improvement in depressed subjects has been described earlier.44,45
Comparisons at baseline showed younger age and fewer with β-blockers in the intervention group. These differences were not statistically significant at the time of inclusion, indicating no major imbalance between intervention and UC women in the randomization process. Instead, the younger age and less usage of β-blockers in the intervention group resulted from the exclusion of the women who withdrew from the study and those who did not complete the follow-up questionnaires.
The women who participated in the Women's Hearts study have earlier been found to be adequately treated concerning classical biological cardiovascular risk factors.1 This is probably an important explanation why there were no deaths during the year. Another explanation may be the time limit of 4 months after their cardiac event before enrollment.
STUDY DESIGN AND LIMITATIONS
Even if the women are at greater risk of a recurrent event earlier after discharge than the 4 months we used as a limit for entering the study, we presumed that the women would have been less susceptible to the psychosocial intervention in an earlier stage because of crisis reactions and massive information from cardiologists to process and reflect on. One question raised after the ENRICHD trial was if the time for initiating their intervention (median 17 days after the index MI) was optimal.15,46 The ENRICHD investigators also questioned if the duration of 6 months of their behavioral intervention, in combination with the early start, was sufficient to have effects on morbidity and mortality.15
The selection of women for a psychosocial intervention program may also be crucial. In the present trial, it seems likely that the women with the highest risk for recurrent events did not participate. The study participants may not be entirely representative of all women with IHD in the population, but they represented those 78% of the eligible women who were willing to participate. Thus, they constituted a population-based sample of women with IHD, suitable for psychosocial intervention. The women who declined to participate were older compared with the study subjects, but age did not significantly modify the treatment effect. The fact that more than 3 out of 4 women in the target group accepted to take part in the trial may reflect the need for psychosocial support felt by a great majority of women with IHD. Close relationships between the local healthcare system and academic medicine in Sweden may also have contributed. Intention-to-treat analyses were not suitable since there were no follow-up data on primary outcomes (psychosocial variables) in the women who withdrew from the study.
The duration and design of a program appear to be crucial for its success. A recent meta-analysis47 has shown that health education and stress management programs can contribute to a reduction of nonfatal and fatal cardiac events in patients with coronary heart disease (mostly men). The meta-analysis also suggests that this effect on distal targets is partly mediated by effects on proximal targets (systolic blood pressure, smoking behavior, physical exercise, and emotional distress). There is evidence that it is the content of the program and not the attendance per se that is related to the outcome.48,49 Reducing psychosocial risk factors may take longer time48 than achieving positive effects of physical exercise.10,50 Positive effects from group treatment51 or at least elements of group sessions10,30,49 have been reported. However, in a program with gender-mixed groups, Burell et al found the setting to be unfavorable for the women in terms of group dynamics.12 Women appear to have a higher sensitivity to psychosocial risk factors regarding IHD than do men.52 Hallman et al found that women had a higher relative sensitivity to work content, workload and control, physical as well as emotional stress reactions, and burnout. They conclude that this probably means that women might gain more than men from actions targeting unhealthy psychosocial conditions. The women's different psychosocial profile, their higher sensitivity to psychosocial risk factors, the unfavorable setting with gender-mixed groups together with the worse prognosis in women prompted us to evaluate a group-based cognitive-behavioral stress management program exclusively for women. The attendance was satisfactory; the average participant attended 17 of a total of 20 group sessions (83%).
Earlier studies have not shown clear-cut results of psychosocial intervention programs in women with IHD.13–15 This may be related not only to differences in intensity and duration of the intervention programs but also to the fact that differences in the needs of men and women were not sufficiently recognized when the programs were designed. The present study has shown the feasibility of a gender-specific approach and its important effects to relieve purposeless self-rated stress behavior and reduce vital exhaustion. Since survival after a coronary event is improving, more emphasis is placed on outcome in terms of quality of life and psychological well-being.53 This may be particularly important for women with IHD, many of whom have been exposed to considerable psychosocial load. Future follow-ups and analyses of the outcomes of the present trial will reveal any possible effects on proximal and distal targets.
This research was funded by the Vårdal Foundation, the Swedish Medical Research Council (grant no K2001-27X-13457-02B), the Swedish Council for Social Research, the Swedish Heart and Lung Foundation, foundations by the Faculty of Medicine and Odontology at the Umeå University, the Norrland Heart Foundation and the Västerbotten County Council. We are grateful to Barbro öström, RN, for data collection and to Katarina Steinholtz, group-leader and physiotherapist, for her competent work in conducting the intervention program.
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