Nicotine & Tobacco Research Advance Access published April 1, 2015 Nicotine & Tobacco Research, 2015, 1–9 doi:10.1093/ntr/ntv039 Original Investigation
Original Investigation
Randomized Controlled Trial of a Healthy Lifestyle Intervention Among Smokers With Psychotic Disorders Downloaded from http://ntr.oxfordjournals.org/ at University of California, San Diego on November 3, 2015
Amanda L. Baker PhD1, Robyn Richmond PhD2, Frances J. Kay-Lambkin PhD1,3, Sacha L. Filia BSc(Hons)4, David Castle MD5, Jill M. Williams MD6, Terry J. Lewin BCom(Psych)Hons1,7, Vanessa Clark BPsych Hons1, Robin Callister PhD8, Natasha Weaver PhD9 Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, Australia; 2School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia; 3 National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia; 4Monash Alfred Psychiatry Research Centre, Central Clinical School, Monash University, Alfred Hospital, Melbourne, Australia; 5 University of Melbourne and Department of Psychiatry, St Vincent’s Hospital, Fitzroy, Australia; 6Division of Addiction Psychiatry, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ; 7Mental Health - Research, Evaluation, Analysis and Dissemination Unit, Hunter New England Mental Health, Newcastle, Australia; 8Priority Research Centre for Nutrition and Physical Activity, University of Newcastle, Callaghan, Australia; 9Clinical Research Design, IT and Statistical Support Unit, School of Medicine and Public Health, University of Newcastle, Callaghan, Australia 1
Corresponding Author: Amanda L. Baker, PhD, Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, 2308, NSW, Australia. Telephone: 61-2-40335690; Fax: 61-2-40335692; E-mail: [email protected]
Abstract 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. 1 © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: [email protected].
Nicotine & Tobacco Research, 2015, Vol. 00, No. 00
2
Introduction
Methods Study Design We conducted a conventional two-arm randomized controlled trial (ie, primary intervention condition hypothesized to be superior to comparison condition), which is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12609001039279). Study design, sample size estimates, and intervention content have been described elsewhere18 and intervention manuals are available from the first author. All participants provided written informed consent and were assessed at baseline, 15 weeks (mid-intervention) and 12 months after baseline; study recruitment occurred between July 2009 and April 2011, with the 12-month follow-up finalized during May 2012. Following baseline assessment, all participants completed an initial, individually-delivered 90-minute face-to-face session, where after they were randomly allocated to receive NRT plus one of
Participants and Procedure Participants were 235 smokers with a stable psychotic disorder who were recruited across three sites (in Newcastle, Sydney, and Melbourne, Australia). Ethical approval was obtained through the lead site (from Hunter New England Human Ethics Committee) and at each site. Referral sources included: health services, such as community mental health centers and general practitioners (148, 63%); media campaigns (59, 25%); and other research programs or registers (28, 12%). Inclusion criteria were: (1) aged at least 18 years; (2) smoking at least 15 cigarettes per day (at any stage of change for quitting smoking); (3) diagnosis of a schizophrenia spectrum or bipolar disorder, as confirmed by the Mini International Neuropsychiatric Interview;19 and (4) taking antipsychotic medication as prescribed for a period of at least 2 months, with intention to continue for the duration of the study. Exclusion criteria were: (1) inability to speak English; (2) organic brain diseases; and (3) medical conditions that would preclude NRT or other treatment. Randomization was stratified by study site, body mass index category (normal; overweight: ≥25 and
Original Investigation
Randomized Controlled Trial of a Healthy Lifestyle Intervention Among Smokers With Psychotic Disorders Downloaded from http://ntr.oxfordjournals.org/ at University of California, San Diego on November 3, 2015
Amanda L. Baker PhD1, Robyn Richmond PhD2, Frances J. Kay-Lambkin PhD1,3, Sacha L. Filia BSc(Hons)4, David Castle MD5, Jill M. Williams MD6, Terry J. Lewin BCom(Psych)Hons1,7, Vanessa Clark BPsych Hons1, Robin Callister PhD8, Natasha Weaver PhD9 Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, Australia; 2School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia; 3 National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia; 4Monash Alfred Psychiatry Research Centre, Central Clinical School, Monash University, Alfred Hospital, Melbourne, Australia; 5 University of Melbourne and Department of Psychiatry, St Vincent’s Hospital, Fitzroy, Australia; 6Division of Addiction Psychiatry, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ; 7Mental Health - Research, Evaluation, Analysis and Dissemination Unit, Hunter New England Mental Health, Newcastle, Australia; 8Priority Research Centre for Nutrition and Physical Activity, University of Newcastle, Callaghan, Australia; 9Clinical Research Design, IT and Statistical Support Unit, School of Medicine and Public Health, University of Newcastle, Callaghan, Australia 1
Corresponding Author: Amanda L. Baker, PhD, Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, Callaghan, 2308, NSW, Australia. Telephone: 61-2-40335690; Fax: 61-2-40335692; E-mail: [email protected]
Abstract 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. 1 © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: [email protected].
Nicotine & Tobacco Research, 2015, Vol. 00, No. 00
2
Introduction
Methods Study Design We conducted a conventional two-arm randomized controlled trial (ie, primary intervention condition hypothesized to be superior to comparison condition), which is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12609001039279). Study design, sample size estimates, and intervention content have been described elsewhere18 and intervention manuals are available from the first author. All participants provided written informed consent and were assessed at baseline, 15 weeks (mid-intervention) and 12 months after baseline; study recruitment occurred between July 2009 and April 2011, with the 12-month follow-up finalized during May 2012. Following baseline assessment, all participants completed an initial, individually-delivered 90-minute face-to-face session, where after they were randomly allocated to receive NRT plus one of
Participants and Procedure Participants were 235 smokers with a stable psychotic disorder who were recruited across three sites (in Newcastle, Sydney, and Melbourne, Australia). Ethical approval was obtained through the lead site (from Hunter New England Human Ethics Committee) and at each site. Referral sources included: health services, such as community mental health centers and general practitioners (148, 63%); media campaigns (59, 25%); and other research programs or registers (28, 12%). Inclusion criteria were: (1) aged at least 18 years; (2) smoking at least 15 cigarettes per day (at any stage of change for quitting smoking); (3) diagnosis of a schizophrenia spectrum or bipolar disorder, as confirmed by the Mini International Neuropsychiatric Interview;19 and (4) taking antipsychotic medication as prescribed for a period of at least 2 months, with intention to continue for the duration of the study. Exclusion criteria were: (1) inability to speak English; (2) organic brain diseases; and (3) medical conditions that would preclude NRT or other treatment. Randomization was stratified by study site, body mass index category (normal; overweight: ≥25 and
