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.

项目概要/摘要患有严重精神疾病的人的烟草使用率仍然高得惊人，例如精神分裂症谱系、双相情感障碍和复发性抑郁症是吸烟的第一大原因。该人群中可预防的死亡原因，从而缩短患有严重精神疾病的成年人的寿命 25 年来，造成了 3170 亿美元的医疗保健支出以及间接收入和残疾损失为个人提供更广泛的戒烟干预措施的新颖有效的模型。患有严重精神疾病的患者非常需要，并且表明移动应用程序是 NIH 的优先事项。尽管应用程序众多，但仍为患有严重精神疾病的人提供戒烟治疗的方法。可用于患有严重精神疾病的人，我们的可行性研究表明，使用这些应用程序给这一人群带来了艰巨的挑战，基于这项工作，我们开发了“学习戒烟”。一款以用户为中心的戒烟应用程序，专为满足严重精神疾病患者的需求而设计。该应用程序的主要活性成分是一种新颖的行为疗法，已显示出戒烟的希望干预——接受和承诺疗法该应用程序提供有关尼古丁使用的教育。替代疗法和美国临床实践指南的建议，以确保与在最近的一项试点随机对照试验 (R00 DA037276) 中，比较了“学习戒烟”与“戒烟”。 NCI 的戒烟指南，我们展示了：(1) 高招募率和保留率，(2) 高水平的用户参与学习戒烟，(3) 进行大型多地点随机对照研究的有效方法试验，以及（4）有希望的戒烟结果，而这项开发工作提供了学习的初步证据。戒烟的可用性、可行性和初步疗效，需要大规模随机对照试验来检验因此，本研究对具有代表性的严重精神疾病患者样本进行了研究。将：(1) 采用随机平行组设计来比较“学习戒烟”与 NCI 戒烟指南的功效， (2) 使用严格的方法来评估应用程序参与度和应用程序功效的中介因素，以及 (3) 检查与专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。研究解决了一个严重的问题——患有严重精神疾病的人吸烟率很高——并且提议使用技术来测试易于获得的戒烟干预措施的有效性高人口覆盖率的潜力。