Randomized Controlled Trial of a Novel Smoking Cessation Application Tailored to Individuals with Serious Mental Illness

针对严重精神疾病患者的新型戒烟应用程序的随机对照试验

• 批准号: 9885332
• 负责人: Roger Vilardaga
• 金额: $ 70.01万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9885332
• 关键词: Abstinence; Address; Adult; Alcohol or Other Drugs use; American; Android; Behavior Therapy; Behavioral Sciences; Biochemical; Cardiovascular Diseases; Cause of Death; Cellular Phone; Chronic; Clinical Practice Guideline; Comprehension; Cost Effectiveness Analysis; DA10; Data; Depressive disorder; Development; Education; Elements; Ensure; Future; General Population; Health Expenditures; Health Policy; Individual; Intervention; Learning; Life Expectancy; Longevity; Measurement; Measures; Mediating; Mediation; Mediator of activation protein; Mental Health; Metabolic Diseases; Methodology; Methods; Modeling; National Institute of Drug Abuse; Nicotine Dependence; Outcome; Participant; Patients; Pennsylvania; Population; Prevalence; Public Health; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Recommendation; Relapse; Research; Respiration Disorders; Sampling; Schizophrenia; Site; Smoker; Smoking; Smoking Cessation Intervention; Structure; Symptoms; Technology; Testing; Time; Tobacco; Tobacco use; Training; Treatment Efficacy; Treatment outcome; United States Dept. of Health and Human Services; United States National Institutes of Health; Universities; Work; arm; base; behavioral pharmacology; cigarette smoke; clinical practice; comorbidity; comparative efficacy; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; craving; design; disability; efficacy testing; evidence base; experience; follow-up; health economics; high risk population; improved; innovative technologies; mHealth; mobile application; mobile computing; nicotine replacement; nicotine use; novel; pilot trial; population health; primary outcome; recruit; retention rate; secondary outcome; severe mental illness; smoking cessation; theories; therapy adherence; usability

PROJECT SUMMARY/ABSTRACT Tobacco use remains at alarming high rates amongst individuals with serious mental illness, such as schizophrenia spectrum, bipolar, and recurring depressive disorders. Smoking tobacco is the number one preventable cause of death in this population, shortening the lifespan of adults with serious mental illness by 25 years and contributing to $317 billion in healthcare expenditures and indirect loss of earnings and disability benefits. Novel and effective models to deliver wider-reaching smoking cessation interventions to individuals with serious mental illness are highly needed and indicated as a priority for NIH. Mobile apps are a promising method to deliver smoking cessation treatments to people with serious mental illness. Despite numerous apps available to use for people with serious mental illness, our feasibility research has demonstrated that using these apps presents daunting challenges for this population. Based on this work, we developed Learn to Quit, a user-centered smoking cessation app tailored to the needs of individuals with serious mental illness. The app’s main active ingredient is a novel behavioral treatment that has shown promise as a smoking cessation intervention -- Acceptance and Commitment Therapy. The app provides education about the use of nicotine replacement therapy and recommendations from US Clinical Practice Guidelines to ensure alignment with best clinical practices. In a recent pilot randomized controlled trial (R00 DA037276), comparing Learn to Quit versus NCI’s QuitGuide, we demonstrated: (1) high recruitment and retention rates, (2) high levels of user engagement with Learn to Quit, (3) an effective method to conduct a large multi-site randomized controlled trial, and (4) promising cessation outcomes. While this developmental work provides initial evidence of Learn to Quit’s usability, feasibility, and preliminary efficacy, a large scale randomized controlled trial is needed to test its efficacy in a representative sample of patients with serious mental illness. Therefore, the proposed study will: (1) employ a randomized parallel arm design to compare the efficacy of Learn to Quit vs. NCI’s QuitGuide, (2) use rigorous methods to evaluate mediators of app engagement and app efficacy, and (3) examine the cost-effectiveness of Learn to Quit compared to a non-tailored app designed for the general population. The study addresses a serious problem -- high smoking rates among people with serious mental illness -- and proposes to test the efficacy of an easily-accessible smoking cessation intervention, using technology with the potential for high population-level reach.

项目摘要/摘要 在患有严重精神疾病的个人中，烟草使用率仍然高得令人震惊，例如 精神分裂症、躁郁症和复发性抑郁障碍。吸烟是第一位的 可预防的死亡原因，使患有严重精神疾病的成年人的寿命缩短了 25年，并导致3170亿美元的医疗支出以及间接收入损失和残疾 福利。为个人提供更广泛的戒烟干预的新的有效模式 严重精神疾病患者是非常需要的，并被列为国家卫生研究院的优先事项。移动应用程序是一个很有前途的 方法为严重精神疾病患者提供戒烟治疗。尽管有许多应用程序 可供严重精神疾病患者使用，我们的可行性研究表明，使用 这些应用程序给这一群体带来了艰巨的挑战。在这项工作的基础上，我们开发了学会戒烟， 一款以用户为中心的戒烟应用程序，专为严重精神疾病患者量身定做。这个 APP的主要活性成分是一种新的行为疗法，已显示出戒烟的前景 干预--接受与承诺疗法。这款应用程序提供尼古丁使用方面的教育 替代疗法和美国临床实践指南中的建议，以确保与最佳 临床实践。在最近的一项试点随机对照试验(R00 DA037276)中，比较了学习戒烟和 NCI的QuitGuide，我们展示了：(1)高招聘和保留率，(2)高用户水平 结合学习戒烟，(3)进行大样本多点随机对照的有效方法 试验，以及(4)有希望的戒烟结果。虽然这项发展工作提供了学习 QUIT的可用性、可行性和初步疗效，需要大规模的随机对照试验来检验 它在具有代表性的严重精神疾病患者样本中的疗效。因此，拟议的研究 Will：(1)采用随机平行臂设计，比较学习戒烟与NCI‘s QuitGuide的疗效。 (2)使用严格的方法评估APP敬业度和APP有效性的中介变量，以及(3)审查 与为普通人群设计的非定制应用程序相比，学习戒烟的成本效益更高。这个 一项研究解决了一个严重的问题--严重精神疾病患者的高吸烟率--以及 建议测试一种易于获得的戒烟干预措施的有效性，使用技术与 高人口水平覆盖的潜力。