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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.

项目总结/文摘