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

基本信息

批准号：
10538646
负责人：
Roger Vilardaga
金额：
$ 64.56万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10538646
关键词：
Abstinence Address Adult American Android Behavior Therapy Behavioral Behavioral Sciences Biochemical Cardiovascular Diseases Cause of Death Cellular Phone Chronic Disease Clinical Practice Guideline Comprehension Cost Analysis 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 Mental Health Metabolic Diseases Methodology Methods Modeling National Institute of Drug Abuse Nicotine Dependence Outcome Participant Patients Pennsylvania Persons Population Prevalence Public Health Quality-Adjusted Life Years Randomized Randomized, Controlled Trials Recommendation Recurrence 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 cigarette smoke clinical practice comorbidity comparative efficacy cost comparison cost effective cost effectiveness cost-effectiveness evaluation craving design disability efficacy evaluation efficacy testing evidence base experience feasibility research follow-up handheld mobile device health economics high risk population improved innovative technologies mHealth mobile application mobile computing nicotine replacement nicotine use novel pharmacologic pilot trial population health primary outcome prolonged abstinence recruit retention rate schizophrenia spectrum disorder secondary outcome severe mental illness smoking cessation substance use treatment theories therapy adherence treatment and outcome usability

项目摘要

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/摘要烟草的使用仍然令人震惊，患有严重精神疾病的人，例如精神分裂症谱，双极和反复出现的抑郁症。吸烟是第一可预防该人群的死亡原因，通过 25年，贡献了3170亿美元的医疗支出和间接损失收入和残疾好处。新颖有效的模型，向个人提供广泛的戒烟干预措施严重的精神疾病非常需要，并表示为NIH的优先事项。移动应用程序是一个承诺为严重精神疾病的人提供戒烟治疗的方法。尽管有许多应用程序可用于严重精神疾病的人，我们的可行性研究表明，使用这些应用程序给这个人群带来了艰巨的挑战。基于这项工作，我们开发了学会退出，以用户为中心的戒烟应用程序，该应用是根据患有严重精神疾病的人的需求量身定制的。 App的主要活性成分是一种新颖的行为治疗，它显示出有望作为戒烟干预 - 接受和承诺疗法。该应用程序提供有关使用尼古丁的教育替代疗法和美国临床实践指南的建议，以确保与最佳保持一致临床实践。在最近的试点随机对照试验（R00 DA037276）中，将学习退出与 NCI的戒烟，我们证明了：（1）高招聘和保留率，（2）高水平的用户参与学习退出，（3）进行大型多站点随机控制的有效方法审判和（4）承诺停止结果。尽管这项发展工作提供了学会的初步证据退出的可用性，可行性和初步效率，需要进行大规模的随机对照试验以进行测试它在患有严重精神疾病的患者的代表性样本中的有效性。因此，拟议的研究威尔：（1）员工是一种随机平行的手臂设计，以比较学习退出与NCI的戒烟的效率，（2）使用严格的方法评估应用程序参与和应用效率的调解人，（3）检查与专为普通人群设计的非批准应用相比，学习退出的成本效益。这研究解决了一个严重的问题 - 患有严重精神疾病的人的吸烟率高 - 提案，以测试易于访问的吸烟干预效率的效率潜在的人口水平高。