The effect of group-based cognitive behavioral therapy on inflammatory biomarkers in patients with coronary heart disease-results from the SUPRIM-trial.

BACKGROUND: The Secondary Prevention in Uppsala Primary Healthcare Project (SUPRIM) is a prospective randomized controlled trial of a group-based cognitive behavioral therapy (CBT) stress management program for coronary heart disease (CHD) patients. The intervention reduced the risk of fatal or non-fatal first recurrent cardiovascular (CV) events. The aim of the present study was to analyze if the positive effects of the CBT program on clinical outcomes could have been mediated by changes in biomarkers for inflammation. METHODS: Altogether 362 patients with CHD were randomly assigned to intervention or usual care. The inflammatory biomarkers (VCAM-1, TNF-R1, TNF-R2, PTX3, and hs-CRP) were serially assessed at five time points every six months from study start until 24 months later, and analyzed with linear mixed models. RESULTS: Baseline levels of the inflammatory markers were near normal, indicating a stable phase. The group-based CBT stress management program did not significantly affect the levels of inflammatory biomarkers in patients with CHD. Three out of five (VCAM-1, TNF-R2, and PTX3) inflammatory biomarkers showed a slight increase over time in both study groups, and all were positively associated with age. CONCLUSION: Group-based CBT stress management did not affect biomarkers for inflammation in patients with CHD. It is therefore unlikely that inflammatory processes including these biomarkers were mediating the effect the CBT program had on the reduction in CV events. The close to normal baseline levels of the biomarkers and the lack of elevated psychological distress symptoms indicate a possible floor effect which may have influenced the results.

Psychological mediators related to clinical outcome in cognitive behavioural therapy for coronary heart disease: A sub-analysis from the SUPRIM trial.

Background The Secondary Prevention in Uppsala Primary Healthcare Project (SUPRIM) was a randomized controlled trial of a group-based cognitive behavioural therapy stress management programme for patients with coronary heart disease. The project was successful in reducing the risk of fatal or non-fatal first recurrent cardiovascular events. The aim of this study was to analyse the effect of cognitive behavioural therapy on self-rated stress, somatic anxiety, vital exhaustion and depression and to study the associations of these factors with the reduction in cardiovascular events. Methods A total of 362 patients were randomly assigned to intervention or usual care groups. The psychological outcomes were assessed five times during 24 months and analysed using linear mixed models. The mediating roles of the outcomes were analysed using joint modelling of the longitudinal and time to event data. Results The intervention had a positive effect on somatic anxiety ( p < 0.05), reflecting a beneficial development over time compared with the controls. Stress, vital exhaustion and depression did not differ between the groups over time. Mediator analysis suggested that somatic anxiety may have mediated the effect of treatment on cardiovascular events. Conclusions The intervention had a small positive effect on somatic anxiety, but did not affect stress, vital exhaustion or depression in patients with coronary heart disease. Somatic anxiety was associated with an increased risk of cardiovascular events and might act as a partial mediator in the treatment effect on cardiovascular events. However, the mechanisms between the intervention and the protective cardiovascular outcome remain to be identified.

Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM).

BACKGROUND: Psychosocial factors are independently associated with increased risk of cardiovascular disease (CVD) morbidity and mortality, but the effects of psychosocial factor intervention on CVD are uncertain. We performed a randomized controlled clinical trial of cognitive behavioral therapy (CBT) to measure its effects on CVD recurrence. METHODS: The study included 362 women and men 75 years or younger who were discharged from the hospital after a coronary heart disease event within the past 12 months. Patients were randomized to receive traditional care (reference group, 170 patients) or traditional care plus a CBT program (intervention group, 192 patients), focused on stress management, with 20 two-hour sessions during 1 year. Median attendance at each CBT session was 85%. Outcome variables were all-cause mortality, hospital admission for recurrent CVD, and recurrent acute myocardial infarction. RESULTS: During a mean 94 months of follow-up, the intervention group had a 41% lower rate of fatal and nonfatal first recurrent CVD events (hazard ratio [95% confidence interval], 0.59 [0.42-0.83]; P = .002), 45% fewer recurrent acute myocardial infarctions (0.55 [0.36-0.85]; P = .007), and a nonsignificant 28% lower all-cause mortality (0.72 [0.40-1.30]; P = .28) than the reference group after adjustment for other outcome-affecting variables. In the CBT group there was a strong dose-response effect between intervention group attendance and outcome. During the first 2 years of follow-up, there were no significant group differences in traditional risk factors. CONCLUSIONS: A CBT intervention program decreases the risk of recurrent CVD and recurrent acute myocardial infarction. This may have implications for secondary preventive programs in patients with coronary heart disease. Trial Registration clinicaltrials.gov Identifier: NCT00888485.

Hazard function and secular trends in the risk of recurrent acute myocardial infarction: 30 years of follow-up of more than 775,000 incidents.

BACKGROUND: The incidence of a first acute myocardial infarction (AMI) has fallen considerably during the last decades. However, no previous studies have analyzed the underlying hazards function of experiencing a recurrent AMI, and none has analyzed the change of risk for a recurrent AMI over the last 3 decades. METHODS AND RESULTS: The study was based on the Swedish national myocardial infarction register. The register contained more than 1 million AMI events. After exclusion of events occurring in subjects younger than 20 or older than 84 years and events with uncertain first AMI status, 775 901 events occurring between 1972 and 2001 remained for analysis. During the study period, the risk of a new event among survivors of a previous AMI decreased sharply during the first 2 years after the previous event, had its minimum after 5 years, and then increased slowly again. The risk for a recurrent AMI during the first year after a previous event was fairly stable over the years until the late 1970s and then decreased by 36% in women and 40% in men until the late 1990s, irrespective of age and AMI number, mirroring the incidence decrease over the years for primary events. CONCLUSIONS: The risk of a recurrent AMI event was highly dependent on time from the previous event, a novel finding which may affect risk scoring. There were strong secular trends toward diminishing risk for a recurrent AMI in recent years, even when other outcome affecting variables were taken into account.

Psychosocial factors during the first year after a coronary heart disease event in cases and referents. Secondary Prevention in Uppsala Primary Health Care Project (SUPRIM).

BACKGROUND: A large number of studies have reported on the psychosocial risk factor pattern prior to coronary heart disease events, but few have investigated the situation during the first year after an event, and none has been controlled. We therefore performed a case-referent study in which the prevalence of a number of psychosocial factors was evaluated. METHODS: Three hundred and forty-six coronary heart disease male and female cases no more than 75 years of age, discharged from hospital within the past 12 months, and 1038 referents from the general population, matched to the cases by age, sex and place of living, received a postal questionnaire in which information on lifestyle, psychosocial and quality of life measures were sought. RESULTS: The cases were, as expected, on sick leave to a larger extent than the referents, reported poorer fitness, poorer perceived health, fewer leisure time activities, but unexpectedly reported better social support, and more optimistic views of the future than the referents. There were no significant case-referent differences in everyday life stress, stressful life events, vital exhaustion, depressive mood, coping or life orientation test. However, women reported less favourable situations than men regarding stressful life events affecting others, vital exhaustion, depressive mood, coping, self-esteem, sleep, and symptom reporting, and female cases reported the most unfavourable situation of all groups. CONCLUSION: In this first controlled study of the situation during the first year after a CHD event disease and gender status both appeared to be determinants of psychological well-being, with gender status apparently the strongest. This may have implications for cardiac rehabilitation programmes.