Objectives of this presentation

1. Smoking and Mental Illness: What can be done to meet the Challenge? Professor Robyn RichmondSchool of Public Health and Community Medicine, UNSWNGO Conference - Cancer Council February 2007

2. Objectives of this presentation List subgroups at risk from tobacco use Identify people with a mental illness as a group with increased health risks Present results from our RCT focussing on reducing smoking among those with a mental illness (study 1) Outline our study taking a CV risk factor approach with those with a mental illness (study 2) Describe relationship between depression and smoking.

3. Smoking Prevalence in Australia • 21% of males > 14 years • 18% of females > 14 years • 14% of males < 14 years • 16% of females < 14 years • 4% of male general practitioners • 2% of female general practitioners. Source: AIHW, 2005

4. Premature deaths due to tobacco use 1-34 yrs 179 35-64 yrs 4,042 65+ yrs 14,798 Total 19,019 Source: Ridolfo & Stevenson, The quantification of drug-caused morbidity and mortality in Australia, 1998, AIHW, 2001

5. Numbers who die from smoking compared with other causes Source: ABS. Causes of Death 1998, 1999; Ridolfo & Stevenson, The quantification of drug-caused morbidity and mortality in Australia, 1998, AIHW, 2001

6. Guidelines for Smoking Cessation in Australian General Practice(Zwar, Richmond, Borland, Stillman, Cunningham, Litt, 2004) and funded by the Commonwealth Dept of Health and Ageing.

7. Guidelines for Australian General Practice focus on smoking cessation for special high risk groups • www.health.gov.au • Pregnant women • Aboriginal and Torres Strait Islanders • People from culturally and linguistically diverse backgrounds • Those with a mental illness.

8. Sub populations at risk • Children • Adolescents • Pregnant women • Aboriginal and Torres Strait Islanders • People from culturally and linguistically diverse backgrounds • People from disadvantaged backgrounds and low socioeconomic status • Prisoners • People with substance use disorders such as alcohol dependence and cannabis • Those with a mental illness (schizophrenia, psychotic illnesses, depression and post traumatic stress disorder).

9. Those with a mental illness • Psychotic disorders andschizophrenia • Depression

10. People with mental illness are a group with increased health risks • Life expectancy for people with schizophrenia and other psychotic disorders is @ 20 years less than their age matched counterparts in the general population, with average life span of 57 years for males and 65 years for females • Most common causes of premature deaths among people with psychoses are suicide, accidental death and CVD • Death rates from CVD among people with psychotic disorders is twice that of the general population. Sources: Weiss et al, 2006; McDermott et al, 2005.

11. People with mental illness are a group with increased health risks Most common risk factors assoc with CV problems which are much higher among those with psychotic disorders are: • poor diet (high in fats, low in fibre) • physical inactivity (mostly sedentary) • obesity (40 - 60% vs 35% in gen pop) • diabetes (>16% vs 7.5% in gen pop) • smoking (73% males, 56% females vs 20% gen pop). Sources: MJA, 2004; Weiss, 2006; McDermott, 2005; McCreadie, 2003.

12. People with mental illness are a group with increased health risks Those with psychotic disorders live in the community, but • generally lack knowledge about making healthy lifestyle choices in the face of complex and often contradictory messages from the media about lifestyle issues • make poor and unhealthy lifestyle decisions • use of some antipsychotic medication (second generation antipsychotics) is assoc with weight gain, glucose and lipid abnormalities and cardiac side effects. Sources: Weiss, 2006; McDermott, 2005; McCreadie, 2003.

13. Smoking among those with a mental illness (schizophrenia, psychotic illnesses) • High rates of smoking among people with mental health problems: 73% in males and 56%in females vs 20% in general population • People with psychotic illnesses tend to smoke more cigarettes with a higher nicotine/tar content and tend to have higher nicotine dependence • Smoking related diseases rate second in frequency to suicide as the greatest contributor to early mortality among people with schizophrenia • As people with schizophrenia are at high risk for developing medical morbidity and mortality related to smoking, helping them to quit smoking is important. Sources: Jablensky et al, 1999; Hughes, 1986

14. Why Do People With A Mental Illness Smoke More? • Therapeutic effects of nicotine on brain function of people with schizophrenia • To alleviate negative symptoms, cognitive dysfunction and side-effects of antipsychotic medication, where smoking is used as a form of self-medication • Social factors • Self report reasons include: addiction, relieving dysphoria, and intoxicating effects of tobacco • Schizophrenic patients tend to be in the early stages of motivation to quit smoking, as assessed by the model of change of smoking behaviour. Sources: Adler et al, 1993; Dalack et al, 1998; Baker et al, 2001; Addington et al, 1997; Prochaska and DiClemente, 1983.

15. Previous research among those with a mental illness • Combination cognitive behavioural therapy (CBT) and pharmacotherapy have been used in seven uncontrolled trials of smoking cessation for people with schizophrenia • Methodological problems with studies: • Small sample sizes, inadequate to identify robust changes • Heterogeneous samples • Lack of defined interventions and control groups • Follow up in many studies only to 6 months • No placebo group.

16. Intervention for smoking among people with a psychotic illness: study 1 Robyn Richmond, Kay Wilhelm School of Public Health and Community Medicine, Faculty of Medicine, UNSW Amanda Baker, Melanie Haile, Frances KayLambkin, Vaughn Carr, Terry Lewin Centre for Mental Health Studies, University of Newcastle Funding sources: NHMRC, CHATA, Rotary, Commonwealth Dept of Health and Ageing.

17. Aims of our Study To evaluate the efficacy of a smoking cessation intervention comprising CBT + MI + NRT for people with a psychotic illness. CBT = cognitive behavioural therapy MI = motivational interviewing NRT = nicotine replacement therapy (transdermal patch).

18. Research Design • Randomised, controlled comparison of routine care (control group) with an intervention consisting of routine care plus an 8 session, individually administered smoking cessation intervention of NRT, MI and CBT. • 298 people with a non-acute psychotic illness were randomly allocated to one of 2 study groups (147 in treatment group and 151 in control group) • Participants were recruited from Sydney and the Hunter Region (150 kilometres north of Sydney).

19. InterventionGroup • The Intervention has multicomponents and is delivered over 8 sessions. Treatment manual written by the authors especially for this study - NDARC Monograph • Sessions 1-3: Motivational Interviewing (developed by Miller and Rollnick), NRT, social support, SANE booklets for smoking cessation (for people with a mental illness and their supporters). Weekly for 1 hr • Sessions 4-6: CBT+ Education + NRT. Weekly for 1 hr • Assessing and avoiding high risk smoking situations • Problem solving; stress management • Coping with cravings/urges • Cigarette refusal skills • Relapse prevention and lifestyle modification • Sessions 7-8: Booster Sessions and review NRT use • Coping strategy enhancement • Relapse prevention • Lifestyle issues.

20. Methodology

21. Outcome measures Outcome measures used to evaluate the impact of CBT + MI + NRT on smoking cessation • Point prevalence • % abstinent for the past 7 days preceding the follow up assessment • includes long-term and short-time quitters • Continuous abstinence • % abstinent since quit day to the last follow up point • the most conservative/stringent measure of outcome as abstinence is considered to be a direct result of intervention • measure of long-term and stable abstinence over time. • Reduction by 50% or greater including abstinence • Abstinence from smoking confirmed using a Micro 11 Smokerlyser which assessed breath levels of CO (level <10ppm signified abstinence).

22. Results: Treatment attendance • Attendance at treatment sessions. • N = 147 in treatment group • 48% (n = 70) attended all of the 8 treatment sessions • 28% (n = 42) attended 5–7 treatment sessions • 24% (n = 35) attended < 5 treatment sessions.

23. Study group • 3 • months • % (n) • 6 • months • % (n) • 12 • months • % (n) • 3 • years • % (n) • Treatment • (147) • 89% • (131) • 87% • (128) • 86% • (126) • 56% • (83) • Control • (151) • 80% • (121) • 77% • (116) • 79.5% • (120) • 54% • (81) • Total • (298) • 85% • (252) • 82% • (244) • 83% • (246) • 55% • (164) Results: Follow up attendance No difference in demographics or smoking behaviours among those who attended the follow-up visits compared to those who did not.

24. Point Prevalence Abstinence over 3 years * *= trend at p<0.01 level of significance

25. Point Prevalence Abstinence by Attendance at all Treatment Sessions compared to control ** ** * • * significant p<0.01 • ** significant p<0.001

26. Continuous Abstinence over 3 years * * Significant, p<0.01

27. Continuous Abstinence by Attendance at Treatment Sessions compared to control ** **significant p<0.001

28. 12 months • 3 years • Control • (n = 151) • 18 • 19 • Treatment • (n = 147) • 31 * • 19 • Self-selected to attend treatment visits • < 5 sessions • 11 • 6 • 5 – 7 sessions • 19 • 12 • 8 sessions • 47 ** • 30 Smoking reduction status including reduction in cigarette consumption by 50% or more and abstinence * p<0 .01; ** p<0.001

29. Change in symptomatology • Group • STAI – State • STAI – Trait • Beck Depression • Treatment • mean • mean • mean • Baseline • 40 • 46.5 • 14 • 3 months • 39 • NA • 13 • 6 months • 37 • NA • 11 • 12 months • 37 • 44 • 12 • 3 years • 36 • 42 • 11 • Control • Baseline • 43 • 49 • 18 • 3 months • 39 • NA • 14 • 6 months • 40 • NA • 14 • 12 months • 35 • 45 • 13 • 3 years • 38 • 43 • 12

30. Conclusions from Study 1 • This is the only RCT of a smoking cessation intervention among people with a psychotic illness • This study has followed people for the longest of any previous trial conducted among people with a psychotic illness – 3 years • CBT + NRT + MI tends to be effective at 3 months among people with a psychotic illness who smoke. • Those who attend all treatment visits of a smoking cessation intervention, are more likely to quit than those who do not complete. Those who chose to attend all 8 sessions were significantly more likely to be abstinent (point prevalence) at 3, 6 and 12 months, and continuously abstinent to 3 months.

31. Conclusions from Study 1 • An important finding was significant improvement on several mental health measures (STAI, depression, overall mental health) and no worsening of psychotic symptomatology. • It is difficult for people with schizophrenia to remain abstinent for prolonged periods without support, which is needed from medical and mental health professionals. Maintenance of treatment gains following successful cessation remains a major challenge.

32. RCT of a multicomponent risk factorintervention for smoking among people with psychotic disorders: study 2 Amanda Baker, Frances KayLambkin Centre for Mental Health Studies, University of Newcastle Robyn Richmond School of Public Health and Community Medicine, Faculty of Medicine, UNSW Jayshri Kulkarni Monash University and Alfred Hospital David Castle Mental Health Research Institute. Funding source for pilot study: Commonwealth Dept of Health and Ageing. Currently seeking NHMRC funding.

33. RCT of a multicomponent risk factorintervention for smoking among people with psychotic disorders: study 2 Aim is to compare the effectiveness of a multicomponent risk factor intervention to promote smoking cessation, healthy eating, physical activity and improvement in CV risk among people with psychosis in four Australian sites.

34. Multicomponent risk factorintervention for smoking among people with psychotic disorders: study 2 • Research Plan • 300 participants will be recruited from 4 sites (100 from Newcastle, 100 from Sydney, 50 each from two sites in Melbourne) • Randomisation to one of two study groups: treatment and control • 3 follow up assessments at 3, 6 and 12 months following initial assessment

35. Interventions for treatment and control groups The Treatment Group Intervention (n = 150) • 6 weekly sessions of cognitive behaviour therapy of 1 hour duration • 3 one hour booster sessions at weeks 8, 10 and 13 • After week 13, one hour booster sessions will occur on a monthly basis for a 6 month period (6 monthly sessions) • Intervention comprises a total of 15 sessions of CBT, motivational interviewing and NRT (patch + lozenge) over a 9 month period • Treatment is based on the Healthy Lifestyles treatment manual developed and pilot tested by the investigators which deals with smoking cessation, diet/nutrition and physical activity modifications.

36. Interventions for treatment and control groups (cont.) The Treatment Group Intervention (n = 150) • Specific components of therapy include: feedback from assessment, psychoeducation of CV risk factors, motivation enhancement, mood/craving monitoring, cognitive restructuring, enhancement of non-smoking, coping with cravings, problem solving refusal skills, relapse prevention and management. • Self help booklet based on Break Free booklet • Referral to Quitline. The Control Group Intervention (n = 150) • One brief session of therapy: feedback from assessment, lifestyle problems, motivational interview, self help booklet • 10 weeks supply of NRT • Referral to Quitline.

38. Quitline smoking cessation counselling

39. Assessments • Tobacco use • Readiness and Motivation to quit smoking • Fagerstrom test for nicotine dependence • carbon monoxide using a smokerlyser • Physical activity • Dietary habits and nutrition • AUDIT • Opiate Treatment Index • Beck Depression Inventory • Brief Symptom Inventory • BMI, waist-hip circumference • BP, blood glucose • Brief Psychiatric Rating Scale • Diagnostic Interview for Psychosis • Service utilisation.

40. Smoking and depression • Smokers are more than twice as likely to be depressed than those who never smoked • Those who report recurrent depressive episodes record the highest rates of smoking • Smokers use nicotine as a means of self-medicating their depressive symptoms and to cope with distress related to depressive symptom development. Sources: Wilhelm et al, 2003; Kessler et al, 2002; Andrews et al, 2002; Glassman et al, 1993; Hurt et al, 1998.

41. Associations between smoking and depression • Several important associations between smoking and depression. Smokers who are dependent on nicotine have: • a higher prevalence of depression (both new and repeated episodes • 2 to 4 times the risk of suicide attempt and completion (which is related to the dose of nicotine) • Highest rates of smoking occur in people with recurrent depressive episodes and bipolar disorder • Smokers with history of depression are over represented among dependent smokers, and smoke more heavily • Smokers are more likely to restart or increase smoking during times of distress; and those with recurrent episodes of depression have the highest rates of smoking. Sources: Wilhelm et al, 2003 and 2004; Breslau et al, 1998; Tanskanen et al, 1998; Kirch, 2000; Hurt et al, 1997.

42. Smoking and depression • Smokers who have a history of depression are at increased risk of problems related to smoking • They have more difficulty quitting • People with a history of depression have problems with more frequent, severe and prolonged withdrawal episodes and more depressive symptoms (anger and irritability) • Among those who are nicotine dependent and have a history of depression, NRT and psychological approaches usually require supplementation with an antidepressant (bupropion or nortriptyline), started a least a week before the quit date. • These antidepressants are effective for those with a lifetime depression history as they appear to assist with dysphoria during withdrawal and prevent relapse. • Psychological and lifestyle strategies, such as motivational interviewing, relaxation exercises and mood charts, assist in mood regulation in addition to smoking treatments • These people should be monitored for several months after quitting to ensure mood stability, as they have a 30% risk of depressive relapse. Sources: Wilhelm, Richmond and Wodak, 2004; Kirch, 2000.

43. Groups considered at risk for problems related to smoking anddepression • Risks of taking up smoking when depressed • Adolescents, with the onset of depression or psychosis • Young women with weight concerns, who may also binge eat • Previous smokers, now depressed or in crisis • Those recently admitted to a psychiatric unit where smoking is permitted and common • Risks of more severe withdrawal when quitting • Young adults with a strong family history of depression and/or drug and alcohol problems • Those abusing alcohol, marijuana and other recreational substances • Those with a clear history of early onset of depression, repeated episodes of depression • Those with significant depressive symptoms prior to cessation • Adults with a smoking related medical illness, not heeding advice to stop smoking • Those who have failed to stop smoking with the usual cessation techniques. Source: Wilhelm, Arnold, Niven and Richmond, 2004

44. Conclusions Focus of the future is to: • Carry out research into smoking cessation treatments that are appropriate and adapted for smokers who have a mental illness • Target prevention strategies to smokers with a mental illness: • education in schools • broad health promotion covering tobacco with other drugs to reduce risk taking behaviours • health promotion on improving CV risk factors and reducing burden of disease, e.g., improving cardiovascular risk factors among those with a mental illness • positive role modelling from parents and community/celebrities • harm minimisation including prevention of exposure to ETS • Offer smoking cessation services for people with a mental illness within treatment services • Offer training for health professionals working within mental health treatment services.

45. Expanding the role of health professionals and welfare providers to offer smoking cessation advice and follow up and other adjuncts to advice to quit • Role of health professionals and other service providers • GP and the practice nurse • Case manager • Psychiatrist • Drug and alcohol treatment providers, e.g., in prison • Teachers • Dentist. • Adjuncts to advice to quit • Range of pharmacotherapies: NRT, antidepressants, varenicline, rimonabant, nicotine vaccine • Quitline.

46. Emerging pharmacological therapies • Varenicline - Selective Nicotine Receptor Partial Antagonist. Actions through binding to the receptor and partially activating as well as blocking action of nicotine. Good results in phase 3 trials. • Rimonabant - Cannabinoid type 1 antagonist. Reduces nicotine withdrawal. Similar efficacy to bupropion in phase 3 trials. Also helps to lose weight.

47. Nicotine vaccines • New vaccine suppresses the reinforcing aspects of nicotine by helping the body clear nicotine from the bloodstream. Designed to bind to nicotine so that it cannot cross blood brain barrier. Studies have shown effectiveness of the vaccine in laboratory research. Now research in humans • Vaccine takes an immunopharmacotherapy approach, i.e. vaccine stimulates the immune system to clear the nicotine from the system • The new idea is to take a chemical that resembles nicotine and use it to induce an active immune response. In this immune response the body produces antibodies against nicotine that neutralise it in the bloodstream. When a cigarette is smoked, the antibodies clear the nicotine from the system before it reaches the brain.