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

项目摘要 在美国，吸烟每年导致48万人死亡，是吸毒死亡人数的三倍。 过量和酒精相关的死亡加在一起，使香烟成为最致命的滥用药物。虽然 尽管吸烟率在过去50年中有所下降，但烟草使用仍然是一个严重问题。抑郁 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的几率： 50%，在标准干预措施中没有得到解决。治疗抑郁症的新方法 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补充，可将抑郁症状作为风险解决 治疗失败的因素。通过移动的健康应用程序（mHealth应用程序）提供服务， 戒烟应用程序下载量超过160万次， 每年仅在美国就有10次。我们进行了焦点小组和个人用户访谈， BAT-D情绪管理应用程序Actify的原型。然后我们在一个单臂试验中对其进行了评估， 这显示了对应用程序的高参与度（平均应用程序登录次数=20），这是一个有希望的短期退出 率为31%，抑郁症状在统计学和临床上显著减少。本研究 建议根据单臂试点数据完善应用程序，整合戒烟内容， 可用性测试，并在试点随机化中评估完整应用程序的可接受性和有效性 对照试验在研究的第一阶段，我们将通过添加戒烟功能来完成Actify的开发 内容，改进应用程序结构以提高可用性，并使用小型 吸烟组（n=15）。第二阶段将是一项初步、随机、对照试验（n=240），比较 使用国家癌症研究所的戒烟mHealth应用程序QuitGuide激活（a）可接受性 (user满意度和应用程序登录次数），（B）戒烟（30天时间点的主要终点 随机分组后8周的戒烟率），以及（c）变化机制（抑郁症状 和行为激活的变化）。这项研究的意义在于解决了重要的公共卫生问题， 戒烟率低的问题以及由此导致的吸烟者与烟草有关的健康差异 症状，它建立在越来越多的文献基础上，这些文献支持行为激活作为一种 停止咨询的组成部分。它在几个关键方面具有创新性，包括：（1）Actify是第一个 同时针对抑郁症和戒烟的任何形式的独立移动健康干预;（2）它 是第一个独立的移动健康应用程序的试点试验，以解决抑郁症作为戒烟的障碍; (3)移动健康应用程序是一个新的和有前途的除了更大的身体移动健康研究的文本 消息传递，这已经证明了有效性。该项目将生成试验数据，以支持R 01级 在一项完全把握度的随机对照试验中测试Actify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.