1. CoRPS Center of Research on Psychology in Somatic diseases Psychosocial support Susanne S. Pedersen, Professor of Cardiac Psychology

2. CoRPS Disclosures None

3. CoRPS Affiliations Prof.dr. Susanne S. Pedersen CoRPS - Center of Research on Psychology in Somatic diseases, Tilburg University, The Netherlands Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands Department of Cardiology, Odense University Hospital, Denmark Phone: + 31 (0) 13 466 2503 E-mail: s.s.pedersen@uvt.nl www.tilburguniversity.nl/corps

4. CoRPS Overview Why bother about psychosocial support? Interventions: Do we know what works? E-health: New kid on the block Clinical practice tips Take home message

5. CoRPS Overview Why bother about psychosocial support? Interventions: Do we know what works? E-health: New kid on the block Clinical practice tips Take home message

6. CoRPS Stress Type D Type A Depression Anger Anxiety PTSD Vital exhaustion Social isolation Hostility

7. CoRPS PCI patients - Minimal symptoms and mortality/MI Pedersen et al. J Gen Intern Med 2009;24:1037-42 Depressed Non-depressed 21/240 26/556 HR: 1.89; 95% CI: [1.06-3.35] % Depressed Non-depressed 21/240 26/556 HR: 1.89; 95% CI: [1.06-3.35] % Depressed Non-depressed 21/240 26/556 HR: 1.89; 95% CI: [1.06-3.35] % Depressed Non-depressed % % % 26/556 21/240 26/556 HR: 1.89; 95% CI: [1.06-3.35] Depressed Non-depressed PHQ-2* cut-off ≥2 (range 0-6) * 1. Little interest or pleasure in doing things 2. Feeling down, depressed, or hopeless N = 796

8. CoRPS ICD patients - Posttraumatic stress symptoms and mortality Ladwig et al. Arch Gen Psychiatry 2008;65:1325-30 N = 147

9. CoRPS Down in the dumps Feeling blue Angry Worried Bad mood Unhappy Type D ? Type D personality - burden of increased negative emotions and inhibition No!! I do not want to share my emotions with others… No!! I do not want to share my emotions with others…

10. CoRPS ICD patients - Anxious Type D patients and ventricular arrhythmias van den Broek, Denollet et al. JACC 2009;54:531-7 N = 391

11. CoRPS Pedersen et al. Europace 2010;12:1446-52 ICD patients - Type D personality and pre- implantation ICD concerns and mortality N = 371 HR: 3.65; 95%CI: 1.57-8.45; p =.003 18.2% 5.2%

12. CoRPS Peripheral arterial disease: Depression and mortality Cherr al. 2008;23:629-34

13. CoRPS Chronic heart failure: Depression, anxiety, social isolation and mortality Friedmann et al. Am Heart J 2006;152:940.e1-940.e8 Cumulative hazard functions: Adjusted HR: 2.25; 95% CI: 1.05-4.73 Adjusted HR: 0.55; 95% CI: 0.42-0.95 Adjusted HR: 1.03; 95% CI: 0.99-1.07

14. CoRPS Prevalence of psychological distress in patients with heart disease A subset of patients: 1 in 4 (25%)

15. CoRPS Why would depression be bad for the heart? Depression CAD Hemostatic changes Elevated blood pressure Activation of the HPA-axis  HRV Health- related behaviours Release of stress hormones Endothelial damage Inflammation Poor prognosis Risk factor clustering Non- compliance Also effects on QoL, adherance, and compliance !!!

16. CoRPS Disclosures Kotseva et al. Lancet 2009;373:929-40

17. CoRPS ICD shock - the paradox Danger? Shock Safety? Braunschweig, Boriani,... Pedersen et al., Europace 2010;12:1673-90

18. CoRPS Overview Why bother about psychosocial support? Interventions: Do we know what works? E-health: New kid on the block Clinical practice tips Take home message

19. CoRPS Key questions How do we get emotionally distressed patients into interventions? How do we keep them in interventions? What to offer patients - what works for whom?

20. CoRPS Possible interventions Cognitive Behavioral Therapy Drug Therapy Psychotherapy Stress Reduction Techniques Counseling

21. CoRPS Trial nameSampleRisk factorTreatmentEndpoint SADHART (2003)369 MI/UAPDepressionSertraline vs.LVEF (safety) placebo ENRICHD (2003)2481 MIDepression/CBT (+SSRI)Recurrent MI/death poor supportvs. UC(all-cause) EXIT (2005) 710 PCIExhaustionBI vs. UCExhaustion/MACE CREATE (2007)284 CADDepression Citalopram vs. Depression IPT vs. UC(HAM-D/BDI) MIND-IT (2007) 91 MIDepressionMirtazapine vs. MACE (safety) placebo Bypassing 302 CABGDepressionPhone-deliveredMental health-related the Blues (2009) collaborative careQoL vs. UC BI = behavioural intervention; IPT = interpersonal psychotherapy; UC = usual care Major intervention trials in CAD

22. CoRPS SADHART – some results Glassman et al. JAMA 2002;288:701-9

23. CoRPS SADHART – some results Glassman et al. JAMA 2002;288:701-9

24. CoRPS Swenson et al. Am J Cardiol 2003;92:1271-6 SADHART – some results

25. CoRPS SADHART – some results Swenson et al. Am J Cardiol 2003:92:1271-6

26. CoRPS ENRICHD - some results Berkman et al. JAMA 2003;289:3106-16

27. CoRPS ENRICHD: Relative survival benefits in pre- planned subgroups Berkman et al. JAMA 2003;289:3106-16

28. CoRPS CBT may be harmful for women May be less effective to target depression immediately post-MI  Perhaps better to focus on those with chronic levels Is CBT the appropriate intervention for cardiac patients?  Assumes that patients have distorted cognitions… Inclusion of less severe cases?  Patients with co-morbid conditions, such as physical illness, personality disorders etc. were excluded… (seen in RESEARCH registry) UC had an unusually high recovery rate  Some patients may have had transient depression related to MI Lessons learned from ENRICHD Jiang et al. Am Heart J 2005;150:54-78 Martens et al. J Affect Disord 2006;94:231-7

29. CoRPS EXIT trial: Worked in patients without previous cardiac history Without history of CAD: 55% reduction (OR: 0.45; 95% CI: 0.30–0.68; p.00) With a history of CAD: 7% reduction but ns (OR: 0.93; 95% CI: 0.56 –1.55; p.78) Intervention reduced the odds of exhaustion at 18 months: Appels et al. Psychosom Med 2005;67:217-23

30. CoRPS Cognitive behavioral therapy in CHD Gullikson et al. Arch Intern Med 2011;171:134-40 N = 362 20 two-hour sessions of CBT in groups (5-9) during one year separate for men and women focusing on stress management of emotional factors Nonfatal first recurrent CVD events: HR: 0.59 [95% CI: 0.42- 0.83] – 41% reduction Recurrent acute myocardial infarctions: HR:0.55 [95% CI: 0.36-0.85] - 45% reduction All-cause mortality: HR: 0.72 [0.40-1.30] - 28% reduction (NS) Particular level of distress was not a prerequisite...

31. CoRPS Collaborative care in CABG patients with depression Rollmann et al. JAMA 2009;302:2095-103 N = 302 8-months telephone- and nursing-delivered collaborative care Real world treatment package (e.g. education about illness, self- management, etc. and consideration of patient preferences)

32. CoRPS Collaborative care in CABG patients with depression Rollmann et al. JAMA 2009;302:2095-103 N = 302

33. CoRPS Powell et al. Arch Intern Med 304:1331-8 Chronic heart failure: Self-management Heart Failure Adherence and Retention Randomized Behavioral Trial (HART) N = 902 18 two-hour group meetings (10 patients) during one year Heart failure education and counselling Problem-solving format patients identifying barriers to implementation p =.46

34. CoRPS Powell et al. Arch Intern Med 304:1331-8 Chronic heart failure: Self-management Heart Failure Adherence and Retention Randomized Behavioral Trial (HART) N = 902 Time by treatment (p =.02)

35. CoRPS Hevey et al. Psychosom Med 2007;69:793-7 Depression and cardiac rehabilitation (CR) paradox CR does lead to reductions in psychological morbidity

36. CoRPS Egger et al. Eur J Cardiovasc Prevention Rehabil 2008;15:704-8 Depression and cardiac rehabilitation (CR) paradox... as corroborated by others

37. CoRPS Depression and cardiac rehabilitation (CR) paradox McGrady et al. J Cardiopulm Rehab Prevention 2009;29:358-64... but paradoxically non-completers and early dropouts have more distress and poorer quality of life

38. CoRPS Depression and cardiac rehabilitation (CR) paradox Lavie et al. Arch Intern Med 2006;166:1878-83... as corroborated by others

39. CoRPS The role of the patient’s attitudes and motivation Dunlay et al. Am Heart J 2009;158:852-9

40. CoRPS The role of type of cardiac rehabilitation Beckie et al. Int J Nurs Studies, In Press Group by time interaction: F(2, 466)=4.42, p =.013 N = 225 depressed CAD women

41. CoRPS What goes wrong? Perhaps the assumption that “one size fits all”

42. CoRPS Overview Why bother about psychosocial support? Interventions: Do we know what works? E-health: New kid on the block Clinical practice tips Take home message

43. CoRPS ICD intervention trial - WEBCARE Pedersen et al. Trials 2009;10:120

44. CoRPS Intervention – web application

45. CoRPS Primary: To investigate whether the web-based intervention is superior to usual care in terms of reducing anxiety, depression, and ICD concerns as well as improving ICD acceptance and quality of life To investigate the cost-effectiveness of the web-based intervention and whether the web-based intervention is associated with reduced health-care utilization WEBCARE – Objectives

46. CoRPS Secondary: To examine whether psychological (i.e., Type D personality and positive affect) and clinical factors (i.e., cardiac resynchronization therapy (CRT)) moderate the effect of the intervention, with a view to developing risk profiles of patients who are less likely to benefit from the intervention Explorative: To explore whether the web-based intervention influences physiological parameters (i.e., ventricular arrhythmias and the cortisol awakening response (CAR)) WEBCARE – Objectives

47. CoRPS WEBCARE – Study design

48. CoRPS WEBCARE - Intervention (fixed, 3-month duration) COMPONENTSTOPICS DEALT WITH Psycho-education about the ICD Problem-solving skills Cognitive restructuring Relaxation training Personalized feedback by a therapist via the computer Emotional reactions to ICD therapy Which aspects of ICD therapy may lead to distress How to deal with shocks Disease-specific issues and fears How to prevent the avoidance of activities Interpretation of bodily symptoms How to cope with uncertainty Help-seeking behavior How to cope with stress

49. CoRPS Reason for initial refusal of participation: Too much work No interest in participating in a study Problems with the website Reason for quitting prematurely: Too confronting / too personal Too time consuming / too much work Problems with the website Reasons for refusal and quitting prematurely

50. CoRPS Overview Why bother about psychosocial support? Interventions: Do we know what works? E-health: New kid on the block Clinical practice tips Take home message

51. CoRPS European Guidelines on Cardiovascular Disease Prevention in Clinical Practice Graham et al. Eur Heart J 2007:28:2375-414 “Interventions adding psychosocial and psychoeducational components to standard cardiological care can significantly improve quality of life and diminish cardiovascular risk factors.”

52. CoRPS Routine screening for depression in patients with CHD in various settings, including the hospital, physician’s office, clinic, and cardiac rehabilitation center. The opportunity to screen for and treat depression in cardiac patients should not be missed, as effective depression treatment may improve health outcomes “No clinical trials have assessed whether screening for depression improves depressive symptoms or cardiac outcomes in patients with cardiovascular disease.” Lichtman et al. Circulation 2008;118;1768-75 Should we routinely screen our patients? Thombs, de Jonge et al. JAMA 2008;300:2161-71

53. CoRPS One size fits some but not all patients

54. CoRPS Back to the drawing board... To optimize interventions in the future Delineate risk profiles of patients, reckoning with psychological factors These factors may interact with demographic and clinical characteristics and type of intervention to influence outcome Match patient (psychological) profiles to different types of interventions – what works for whom ‘One size fits all’ also does not apply to medical therapy

55. CoRPS

56. The role of the health care professionals in behavior change Rozanski A. Psychosom Med 2005;67:S67-73 For patients, to initiate behavior change is difficult The more difficult the behavior, the more difficult the practice Learning new behaviors is easier than breaking ‘old’ habits Most difficult habits to change are those feeding physiologic addictions (e.g., smoking)

57. CoRPS Factors important for enhancing adherence Removing barriers to health habit change (e.g., depression and fatigue)  10 min of rapid walking may  energy and  tension levels for up to 2 hours later; relaxation therapy Providing external support for maintaining health behaviors (e.g., social support, CR, etc) Motivate patients to initiate own self-management of behavior  patients are more likely to change and maintain behavior changes that they ‘feel’ are meaningful to them (e.g. emotionally laden – AMI) Rozanski A. Psychosom Med 2005;67:S67-73

58. CoRPS

59. Establish a good rapport with patients and partners Know who they are – screen for psychological distress and monitor over time Refer patients to cardiac rehabilitation – it works Look at body language and non-verbal cues Check if their medication and general treatment can be optimized further Involve the partner – but also distress in partner Referral to mental health professional if available Tips for dealing with high-risk patients in clinical practice

60. CoRPS Overview Why bother about psychosocial support? Interventions: Do we know what works? E-health: New kid on the block Clinical practice tips Take home message

61. CoRPS Take home message Psychological factors are independent predictors of prognosis despite state-of-the-art treatment A subset (25%-33%) are at risk of poor health outcomes Screen and monitor – we need to know who they are Incorporation of health status assessment in clinical practice Multi-factorial psychosocial/behavioral interventions targeted to the individual most likely to be successful

62. CoRPS Time for action Behavioral factors were included in the ESC guidelines for secondary prevention in 2003 (Vienna) – talk on “How to identify depression in routine clinical practice” A feeling that nothing much has changed in clinical practice in 8 years We do not have all the answers yet... How much more evidence do we need? What are we waiting for? WE CAN DO BETTER TO IMPROVE PATIENT CARE ! ESC press statement: January 28, 2011 Additional guidelines on stress management, Perk added, will be included in the upcoming European Guidelines on CVD Prevention in clinical practice, due to be launched in Dublin in 2012 at the 5th Joint European Societies Taskforce on CVD Prevention.

63. CoRPS Living in a Device World: Focus on Recent Challenges and Tools to Improve Clinical Care for Patients with an Implantable Cardioverter Defibrillator Device Conference, 3-4 November 2011, Tilburg, the Netherlands Themes OVERCOMING THE SHOCK OF THE ICD ICD REGISTRIES AND THE INCLUSION OF THE PATIENT PERSPECTIVE DEACTIVATION OF THE ICD AND END OF LIFE ISSUES NEGLECTED SUBGROUPS CRT SELECTION AND RESPONSE THE DO’S AND DON’TS OF PATIENT COMMUNICATION SEXUALITY IN ICD PATIENTS BEHAVIORAL INTERVENTIONS LOOKING INTO THE FUTURE Selection of invited faculty Nico Blom (MD, PhD), Leiden University Medical Center, NL Matthew Burg (PhD), Yale School of Medicine, USA Viviane Conraads (MD, PhD), University Hospital Antwerpen, BE Dorothy Frizelle (PhD), University of Hull, UK Jens Brock Johansen, (MD, PhD), Odense University Hospital, DK Karl-Heinz Ladwig (MD, PhD), Helmholtz Institute, Munich, GE Mathias Meine (MD, PhD), University Medical Center Utrecht, NL Susanne S. Pedersen (PhD), CoRPS, Tilburg University, NL Samuel Sears (PhD), East Carolina University, USA Steen Pehrson (MD, PhD), Copenhagen University Hospital, DK Dominic Theuns (PhD), Erasmus Medical Center Rotterdam, NL More information available on: www.tilburguniversity.edu/device2011