An mHealth mood management tool to improve population-level tobacco cessation

项目总结 在美国，吸烟每年导致超过48万人死亡--比吸毒高出三倍 过量服药和与酒精有关的死亡加在一起，使香烟成为最致命的滥用药物。虽然 吸烟率在过去50年里有所下降，但烟草使用仍然是一个严重的问题。抑郁症 在尝试戒烟的吸烟者中非常普遍的症状，通过以下方式降低戒烟几率 50%，并且没有在标准干预措施中得到解决。治疗抑郁症状的新方法 非常需要退出尝试的上下文。抑郁症的行为激活疗法(BAT-D)是一种 标准戒烟干预措施的新增加，可以将抑郁症状作为一种风险来处理 治疗失败的因素。通过移动健康应用程序(mHealth应用程序)进行交付使这一点具有针对性 随着戒烟应用程序的下载量超过160万，提供高覆盖形式的治疗 每年仅在美国。我们进行了焦点小组和个人用户访谈，以制定有限的 一款名为Actify的BAT-D情绪管理应用的原型。然后我们在单臂飞行员试验中对其进行了评估， 显示出对该应用程序的高度参与度(应用程序平均登录次数=20)，这是一个有希望的短期退出 治愈率为31%，抑郁症状在统计学上和临床上均有显著减少。在这项研究中，我们 建议基于单臂试点数据细化APP，整合戒烟内容，进行 可用性测试，并在试点中随机评估完成的APP的可接受性和有效性 对照试验。在研究的第一阶段，我们将通过添加Stop来完成Actify的开发 内容，优化应用程序结构以提高可用性，并使用小型 吸烟组(n=15)。第二阶段为试点、随机、对照试验(n=240)。 使用国家癌症研究所的戒烟mHealth应用QuitGuide激活(A)可接受性 (用户满意度和应用程序登录次数)，(B)戒烟(30天点的主要终点 (C)改变的机制(抑郁症状 和行为激活的改变)。这项研究具有重要的意义，因为它涉及到重要的公共卫生 有情绪的吸烟者戒烟率低和由此导致的与烟草相关的健康差距问题 症状，它建立在越来越多的文献的基础上，支持行为激活作为一种 戒烟咨询的组成部分。它在几个关键方面具有创新性，包括：(1)Actify是第一个 任何类型的针对抑郁症和戒烟的独立mHealth干预；(2) 是第一个针对抑郁症作为戒烟障碍的独立mHealth应用程序的试点试验； (3)移动健康应用程序是对文本上更大规模的移动健康研究的一个新的、有前途的补充 消息传递，已经证明是有效的。该项目将生成支持R01-Level的试点数据 在完全有效的随机对照试验中测试Actify的有效性的项目。

PROJECT SUMMARY Cigarette smoking is responsible for over 480,000 deaths annually in the US—three times higher than drug overdose- and alcohol-related deaths combined—making cigarettes the most deadly drug of abuse. Although smoking rates have declined over the past 50 years, tobacco use remains a critical problem. Depression symptoms, which are highly prevalent among smokers making a quit attempt, reduce the odds of cessation by 50% and are not addressed in standard interventions. New methods for addressing depressive symptoms in the context of a quit attempt are greatly needed. Behavioral activation therapy for depression (BAT-D) is a novel addition to standard smoking cessation interventions that can address depressive symptoms as a risk factor for treatment failure. Delivery through a mobile health application (mHealth app) makes this targeted treatment available in a high-reach format, as apps for smoking cessation are downloaded over 1.6 million times per year in the US alone. We conducted focus groups and individual user interviews to develop a limited prototype of a BAT-D mood management app called Actify. We then evaluated it in a single-arm pilot trial, which showed high engagement with the app (mean number of app logins=20), a promising short-term quit rate of 31%, and a statistically and clinically significant reduction in depression symptoms. In this study, we propose to refine the app based on single-arm pilot data, integrate smoking cessation content, conduct usability testing, and evaluate the acceptability and efficacy of the completed app in a pilot randomized controlled trial. In the first phase of the study, we will complete the development of Actify by adding cessation content, refining the app structure to improve usability, and conducting additional prototype testing with a small group of smokers (n=15). The second phase will be a pilot, randomized, controlled trial (n=240) comparing Actify with QuitGuide, the National Cancer Institute’s mHealth app for smoking cessation, on (a) acceptability (user satisfaction and number of app logins), (b) smoking abstinence (primary endpoint of 30-day point prevalence abstinence at 8 weeks post-randomization), and (c) mechanisms of change (depressive symptoms and change in behavioral activation). This study is significant in that addresses the important public health problem of low quit rates and resultant tobacco-related health disparities among smokers experiencing mood symptoms, and it builds off of a growing body of literature supporting the value of behavioral activation as a component of cessation counseling. It is innovative in several key respects, including: (1) Actify is the first standalone mHealth intervention of any kind to target depression and smoking cessation simultaneously; (2) it is the first pilot trial of a standalone mHealth app to address depression as a barrier to quitting smoking; and, (3) mHealth apps are a novel and promising addition to the larger body of mHealth research on text messaging, which has demonstrated efficacy. This project will generate pilot data to support an R01-level project testing the effectiveness of Actify in a fully-powered, randomized controlled trial.