Success factors in Behavioral Medicine

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1 Success factors in Behavioral Medicine interventions post myocardial infarction Depression Gunilla post myocardial Burell, PhD infarction Department of Public Health, Uppsala University, Sweden XIII Svenska Kardiovaskulära Vårmötet 4 maj 2011, Örebro Success factors in Behavioral Medicine Gunilla Burell, PhD interventions Department of Public post Health, myocardial Uppsala University, Sweden infarction Ingen intressekonflikt.

2 Background Psychosocial factors, such as stress load and stress behaviors, are independently associated with increased risk of cardiovascular disease (CVD) morbidity and mortality. e g the Interheart Study However, the outcome effect of intervention on these factors on these endpoints has so far been uncertain. e g the M-HART and ENRICHD Studies Therefore more intervention studies are needed Therefore, more intervention studies are needed, particularly outcome evaluations of behavioral programs.

3 Some previous findings Case-control studies Women s Hearts Trial

4 SUPRIM Case-control 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) Mats Gulliksson, Gunilla Burell, Lennart Lundin, Henrik Toss and Kurt Svärdsudd Published: 21 November 2007 BMC Cardiovascular Disorders 2007, 7:36 doi: / This article is available from:

5 SUPRIM Case-control 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 assessed. 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. 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. CHD disease and gender status both appeared to be determinants of psychological well-being, with gender status apparently the strongest.

6 Women s Hearts Case-control Psychosocial distress and impaired quality of life targets neglected in the secondary prevention in women with ischaemic heart disease. Maria Claesson, Gunilla Burell, Lisbeth Slunga Birgander, Bernt Lindahl and Kjell Asplund European Journal of Cardiovascular Prevention and Rehabilitation 2003, 10:

7 CHD women vs. healthy controls Compared to women without CHD, women with CHD reported significantly more stress behaviour and vital exhaustion. Women with CHD also had lower heart rate and a lower heart rate variability (HRV) than the healthy controls. The lower heart rate most likely was attributable to use of beta- blockers, but the lower HRV could reflect a dysfunctional autonomic nervous regulation of the heart rate. Reduced HRV is reported in post-ami patients and have been shown to increase the risk of cardiac arrhythmias and sudden death.

8 Women s Hearts Trial Women s Hearts Stress Management for Women With Ischemic Heart Disease EXPLANATORY ANALYSES OF A RANDOMIZED CONTROLLED TRIAL Maria Claesson, MS; Lisbeth Slunga Birgander, MD, PhD; Bernt Lindahl, MD, PhD; Salmir Nasic, MSci; Monica Åström, MD, PhD; Kjell Asplund, MD, PhD; Gunilla Burell, PhD Journal of Cardiopulmonary Rehabilitation 2005;25:93-102

9 Women s Hearts Trial: Aims and design In the Women s Hearts study, we have evaluated a one-year cognitivebehavioural stress management program designed specifically for women with IHD, in a randomised controlled trial. 198 women with IHD, with a mean age of 61 years and from the county of Västerbotten tt in Northern Sweden, were randomised d to either conventional treatment and follow-up of patients with IHD, or the stress management in addition to usual care.

10 Results At the first follow-up, the women who had participated in the stress management program had reduced the stress behavior and vital exhaustion, compared to the women in the usual care group. We could not find any evidence of a direct cause-effect relationship between stress management and biological cardiovascular risk indicators, or HRV; the intervention and control groups did not differ in insulin resistance, inflammatory, haemostatic and fibrinolytic factors, or HRV.

11 Conclusions and unanswered questions Cognitive-behavioral stress management treatment could accelerate psychosocial improvement in women with IHD, and thus reduce the amount of psychological and psychosocial suffering. Our results suggest that the patients with the greatest psychosocial burden should be identified and targeted. Consistent positive findings for effects on soft endpoints, but how about hard endpoints?

12 SUPRIM Trial 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) Mats Gulliksson, MD, PhD; Gunilla Burell, PhD; Bengt Vessby, MD, PhD; Lennart Lundin, MD, PhD; Henrik Toss, MD, PhD; Kurt Svärdsudd, MD, PhD Arch Intern Med. 2011;171(2):

13 SUPRIM Study: Methods Gunilla Burell 362 men and women, aged 75 or less, discharged from hospital after a coronary heart disease (CHD) event within the past 12 months, were randomized to cognitive behavioral therapy (CBT) focused on stress management during one year (n=192), or to usual care (n=170). There were no significant differences between intervention and control patients. Risk factor and quality of life data were measured at baseline and after 6, 12, 18, 24 months. Hospital admission data and survival data were obtained from national registers. Median attendance rate to the intervention program was 85%.

14 Treatment program Gunilla Burell Groups of 6-8 participants, separate groups for men and women Twenty 2-hour sessions during months Agendas and specific themes for each session Working material, exercises Homework assignments individual; shared by all group members Relaxation training

15 Treatment components Education Self-monitoring Behavioral skills training Application and practice Cognitive restructuring Spiritual development

16 Results (CVD endpoints) During 8 years of follow-up the intervention group had 41% less fatal and non-fatal first recurrent CVD rate (HR 0.59, 95%CI , p=0.003), and 45% less recurrent acute myocardial infarction (AMI) rate (HR 0.55, 95%CI , p=0.007) than the control group. There was a non-significant all cause mortality group difference (HR 0.72, 95%CI ). There was a strong dose-response effect between intervention group attendance and outcome.

17 Cumulative first recurrent fatal and non-fatal cardiovascular event, during 9 years (108 months) from baseline, adjusted. Gunilla Burell Reference group Behavioural intervention group Follow-up time, months

18 Cumulative first recurrent fatal and non fatal acute myocardial infarction, during 9 years (108 months) from baseline, adjusted. d Reference group Behavioural intervention group Follow-up time, months

19 Numbers needed to treat Gunilla Burell In order to prevent one CVD recurrent event nine subjects needed to be treated (NNT). The corresponding measure for AMI recurrence was The corresponding measure for AMI recurrence was 10 subjects.

20 Conclusions The CBT stress intervention decreased the risk of recurrent CVD and recurrent AMI. The effect was not due to differences in standard risk factors. A dose-response relationship between therapy attendance rate and recurrence implies that the effects were related to the components of the intervention.

21 Clinical implications Results from previous intervention trials and the SUPRIM Study imply that effective programs to reduce stress and the risk of recurrent events in CHD patients should Be conducted with group format Be long-term (several months) Have focus on development of behavioral coping skills Be led by group leaders with special training background Probably be gender separated

22 Thank you for your attention!

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