Randomized controlled trial of a healthy lifestyle intervention among smokers with psychotic disorders

Introduction: People with severe mental disorders typically experience a range of health problems; consequently, interventions addressing multiple health behaviors may provide an efficient way to tackle this major public health issue. This two-arm randomized controlled trial among people with psychotic disorders examined the efficacy of nicotine replacement therapy (NRT) plus either a faceto- face or predominantly telephone delivered intervention for smoking cessation and cardiovascular disease (CVD) risk reduction. Methods: Following baseline assessment and completion of a common, individually delivered 90-minute face-to-face intervention, participants (n = 235) were randomized to receive NRT plus: (1) a "Healthy Lifestyles" intervention for smoking cessation and CVD risk behaviors or (2) a predominantly telephone-based intervention (designed to control for NRT provision, session frequency, and other monitoring activities). Research assistants blind to treatment allocation performed assessments at 15 weeks (mid-intervention) and 12 months after baseline. Results: There were no significant differences between intervention conditions in CVD risk or smoking outcomes at 15 weeks or 12 months, with improvements in both conditions (eg, 12 months: 6.4% confirmed point prevalence abstinence rate; 17% experiencing a 50% or greater smoking reduction; mean reduction of 8.6 cigarettes per day; mean improvement in functioning of 9.8 points). Conclusions: The health disparity experienced by people with psychotic disorders is high. Faceto- face Healthy Lifestyle interventions appear to be feasible and somewhat effective. However, given the accessibility of telephone delivered interventions, potentially combined with lower cost, further studies are needed to evaluate telephone delivered smoking cessation and lifestyle interventions for people with psychotic disorders.