Centre for Brain and Mental Health Research, Faculty of Health, University of Newcastle, Callaghan, NSW 2308, Australia.
BMC Public Health. 2011 Jan 5;11(1):10. doi: 10.1186/1471-2458-11-10.
The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD). The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders.
METHODS/DESIGN: 250 smokers with a severe mental disorder will be recruited. After completion of a baseline assessment and an initial face-to-face intervention session, participants will be randomly assigned to either a multi-component intervention for smoking cessation and CVD risk reduction or a telephone-based minimal intervention focusing on smoking cessation. Randomisation will be stratified by site (Newcastle, Sydney, Melbourne, Australia), Body Mass Index (BMI) category (normal, overweight, obese) and type of antipsychotic medication (typical, atypical). Participants will receive 8 weekly, 3 fortnightly and 6 monthly sessions delivered face to face (typically 1 hour) or by telephone (typically 10 minutes). Assessments will be conducted by research staff blind to treatment allocation at baseline, 15 weeks, and 12-, 18-, 24-, 30- and 36-months.
This study will provide comprehensive data on the effect of a healthy lifestyle intervention on smoking and CVD risk among people with severe mental disorders. If shown to be effective, this intervention can be disseminated to treating clinicians using the treatment manuals.
Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: ACTRN12609001039279.
严重精神障碍患者的最大单一死因是心血管疾病（CVD）。大多数精神分裂症和双相情感障碍患者吸烟，许多人还超重，这大大增加了他们患 CVD 的风险。治疗吸烟和其他健康风险行为通常不是严重精神障碍患者的优先事项。本方案描述了一项研究，我们将评估健康生活方式干预对严重精神障碍患者吸烟和 CVD 风险及相关健康行为的有效性。
方法/设计：将招募 250 名患有严重精神障碍的吸烟者。完成基线评估和初始面对面干预后，参与者将被随机分配到多组分戒烟和降低 CVD 风险干预组或基于电话的专注于戒烟的最低限度干预组。随机分组将按地点（澳大利亚纽卡斯尔、悉尼、墨尔本）、体重指数（BMI）类别（正常、超重、肥胖）和抗精神病药物类型（典型、非典型）分层。参与者将接受 8 次每周、3 次每两周和 6 次每月的面对面（通常 1 小时）或电话（通常 10 分钟）会议。评估将由研究人员在基线、15 周、12 个月、18 个月、24 个月、30 个月和 36 个月时进行，评估人员对治疗分配情况不知情。
这项研究将提供关于健康生活方式干预对严重精神障碍患者吸烟和 CVD 风险影响的全面数据。如果证明有效，这种干预措施可以使用治疗手册向治疗临床医生传播。
澳大利亚新西兰临床试验注册（ANZCTR）标识符：ACTRN12609001039279。
