Randomized Trial of a Smoking Cessation Program for Persons with SMI

SMI 患者戒烟计划的随机试验

• 批准号: 7786750
• 负责人: LISA B. DIXON
• 金额: --
• 依托单位: BALTIMORE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-10-01 至 2013-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7786750
• 关键词: Abstinence; Address; Aftercare; American Lung Association; Attention; Behavior Therapy; Behavioral; Biological; Bupropion; Carbon Monoxide; Categories; Cessation of life; Characteristics; Cigarette; Clinic; Clinical Practice Guideline; Cocaine; Cognitive; Communities; Department of Defense; Diabetes Mellitus; Diagnostic; Disabled Persons; Disease; Drug usage; Education; Effectiveness; Ensure; Face; Funding; General Population; Goals; Grant; Guidelines; Health; Health Care Costs; Health care facility; Healthcare; Healthcare Systems; Heart Diseases; Heroin; Impairment; Intervention; Life; Malignant neoplasm of lung; Maryland; Measures; Medical Economics; Mental Health; Mental disorders; Modeling; Morbidity - disease rate; National Institute of Drug Abuse; Nicotine Dependence; Obesity; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmacotherapy; Phase; Policies; Population; Procedures; Public Health; Randomized; Randomized Clinical Trials; Readiness; Recruitment Activity; Reporting; Research; Schizophrenia; Series; Severities; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Social support; Specific qualifier value; Substance Addiction; Substance Use Disorder; Substance abuse problem; Technology; Testing; Tobacco use; United States; United States Agency for Healthcare Research and Quality; Veterans; Withholding Treatment; Work; abstracting; addiction; base; cigarette smoking; contingency management; cost; design; evidence base; follow-up; handicapping condition; health care quality; improved; innovation; meetings; mortality; nicotine replacement; novel strategies; outreach; programs; psychologic; public health relevance; randomized trial; smoking cessation; social; social model; substance abuser; therapy development; tool; treatment program; trial comparing

DESCRIPTION (provided by applicant): Abstract Over 70% of people with serious and persistent mental illnesses (SPMI) smoke cigarettes. We have found that delivery of the 5 As of smoking cessation (Ask, Advise, Assess, Assist, Arrange) to persons with SPMI, a practice required by the VA, produces modest reductions in smoking and some increased use of smoking cessation aids, but does not increase abstinence. Existing "best practices" for smoking cessation in SPMI produce low short-term abstinence rates and almost no sustained abstinence. A new approach is needed that is designed for persons with SPMI and utilizes all available strategies for addiction treatment. We have developed an intervention called "Behavioral Treatment of Smoking Cessation in SPMI" (BTSCS), an innovative program that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment that addresses the cognitive, motivational, and social support problems characteristic of people with SPMI. We propose to conduct a randomized trial of BTSCS compared to a manualized standard cessation program (StSST) that reflects current best practices. BTSCS was modeled after a successful program (Behavioral Treatment of Substance Abuse in SPMI) created by the study team that was designed for people with dual disorders. Hypotheses: We hypothesize that BTSCS will be more effective than StSST in producing and sustaining abstinence as measured by self report and expired CO levels. Subject Population: We will recruit 210 people with SPMI who smoke at least 10 cigarettes per day from the VA Maryland Healthcare System. We expect to randomize 178 people. Procedures: Participants in both conditions will receive brief outreach. Research assessments will be completed at baseline, 3 months (end of treatment), and 3- and 6- month follow ups. Potential Impact on Veterans' Health Care: The VA has recognized the high medical, economic, and social costs of smoking with directives to ensure that veterans are offered cessation programs. Testing an innovative smoking cessation treatment for persons with SPMI is highly significant for the VA because: (1) the rates of smoking among veterans are higher that the general population; (2) smoking rates among persons with SPMI are higher still, and; (3) there are virtually no smoking cessation treatments for veterans with SPMI that are effective in producing abstinence. PUBLIC HEALTH RELEVANCE: Project Narrative Despite widespread recognition of the devastating health effects of smoking and the extraordinarily high rates of smoking in people SMI, smoking in SMI has not received the full and urgent attention that it deserves. Given the elevated rates of smoking among patients with SMI, our efforts to test an innovative, broad-based smoking cessation program that is tailored to the needs of this multi-handicapped population carry significant cost, health, and quality of care implications. Integration of smoking cessation within the context of mental health treatment will also provide a new context for addressing nicotine addiction, further enhancing the public health significance of the research.

描述（由申请人提供）： 摘要超过70%的严重和持续性精神疾病（SPMI）患者吸烟。我们发现，向SPMI患者提供戒烟的5个A（询问，建议，评估，协助，安排），这是VA要求的做法，可适度减少吸烟和增加使用戒烟辅助工具，但不会增加禁欲。SPMI现有的戒烟“最佳实践”产生的短期戒烟率低，几乎没有持续戒烟。需要一种新的方法，为SPMI患者设计，并利用所有可用的成瘾治疗策略。我们开发了一种名为“SPMI戒烟行为治疗”（BTSCS）的干预措施，这是一项创新计划，通过应急管理和多方面行为组治疗补充药物治疗和教育，以解决SPMI患者的认知，动机和社会支持问题。我们建议进行一项BTSCS与反映当前最佳实践的手动标准戒烟计划（StSST）相比的随机试验。BTSCS是仿照一个成功的计划（SPMI中物质滥用的行为治疗），该计划由研究小组创建，专为患有双重疾病的人设计。假设：我们假设BTSCS在产生和维持禁欲方面比StSST更有效，如通过自我报告和过期CO水平测量的。受试者人群：我们将从VA马里兰州医疗保健系统招募210名每天至少吸烟10支的SPMI患者。我们预计随机抽取178人。程序：两种情况下的参与者都将接受简短的外展。将在基线、3个月（治疗结束）以及3个月和6个月随访时完成研究评估。对退伍军人医疗保健的潜在影响：退伍军人事务部已经认识到吸烟的医疗、经济和社会成本很高，并指示确保为退伍军人提供戒烟计划。对SPMI患者进行创新性戒烟治疗的试验对退伍军人管理局具有非常重要的意义，因为：（1）退伍军人的吸烟率高于一般人群;（2）SPMI患者的吸烟率更高;（3）几乎没有有效戒烟的SPMI退伍军人戒烟治疗。 公共卫生相关性： 尽管人们普遍认识到吸烟对健康的破坏性影响以及重度精神病患者的吸烟率非常高，但重度精神病患者的吸烟问题尚未得到应有的充分和紧迫的关注。鉴于重度精神障碍患者吸烟率的升高，我们努力测试一种创新的、基础广泛的戒烟计划，该计划针对这一多重残疾人群的需求，具有重大的成本、健康和护理质量影响。将戒烟与心理健康治疗相结合也将为解决尼古丁成瘾问题提供新的背景，进一步增强研究的公共卫生意义。