Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/Depression in People Living with HIV

解决艾滋病毒感染者戒烟和焦虑/抑郁问题的综合治疗的有效性

基本信息

批准号：
10400306
负责人：
Conall Michael O'Cleirigh
金额：
$ 0.97万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-15 至 2022-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10400306
关键词：
Abstinence Address Anhedonia Anxiety Behavioral Boston Clinic Cognitive Communicable Diseases Community Health Cost Effectiveness Analysis Disadvantaged Dissemination and Implementation Effectiveness Emotional Enrollment Exposure to Funding General Hospitals HIV Health Healthcare Human immunodeficiency virus test Intervention Life Expectancy Maintenance Massachusetts Mental Depression Mental Health Services Names National Institute of Drug Abuse Patients Population Prevalence Randomized Controlled Trials Research Project Grants Resources Service setting Site Smoker Smoking Social Work Specific qualifier value Subgroup Testing Time Tobacco use Translations Treatment Protocols United States World Health antiretroviral therapy anxiety sensitivity arm base behavioral health cost effectiveness cost estimate design distress tolerance effectiveness trial efficacy testing feasibility trial follow-up health disparity health disparity populations primary outcome secondary outcome smoking cessation smoking prevalence smoking relapse standard of care stressor success treatment as usual

项目摘要

Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations. Smokers living with HIV represent a major health disparity population in the United States (US) and the world more generally, and their unique healthcare needs are not being adequately addressed. For people living with HIV, smoking is related to poorer survival and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. The proposed intervention is informed, in part, by the success of our recently completed NIDA-funded R34 research project (R34DA031038) in which we specified and tested in a small open trial, and then, a pilot randomized controlled trial (RCT) the feasibility, acceptability and initial efficacy of a 9-session, cognitive- behavioral-based intervention (named QUIT) to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia). This intervention was specifically adapted and designed for smokers living with HIV. The results from this study revealed that, when compared to a brief enhanced treatment as usual control intervention (ETAU), patients assigned to QUIT achieved higher short-term (end of treatment [EOT]: QUIT: 59% vs. ETAU: 9%) and long- term (6-month follow-up: QUIT: 46% vs. ETAU: 5%) abstinence rates.9 We now propose to conduct a fully powered, 3-arm efficacy/effectiveness trial. We propose to enroll 180 smokers living with HIV across three implementation sites [(1) Infectious Disease Clinic, Massachusetts General Hospital (MGH), Boston, (2) Fenway Community Health, Boston, and (3) Thomas Street Health Center, Houston]. We seek to test the efficacy/effectiveness of the QUIT intervention at increasing point prevalence abstinence (primary outcome), by reducing anxiety and depression (secondary outcomes), and to determine if it outperforms an active, credible time-matched control, and a standard-of-care (SOC) control. The integration of resource utilization and cost-effectiveness analyses and the third SOC control arm support estimation of cost and effectiveness. If successful, the intervention would be ready for translation studies to examine implementation and dissemination into “real-world” health, mental health, and social service settings.

尽管过去 50 年来吸烟率有所下降，但烟草使用量仍存在巨大差异仍然存在于几个亚群体中，特别是弱势群体和健康受损群体。艾滋病毒感染者是美国和世界范围内主要的健康差距人群一般来说，艾滋病毒感染者独特的医疗保健需求没有得到充分满足。吸烟与坚持抗逆转录病毒治疗的患者生存率较差有关吸烟比艾滋病毒更能缩短预期寿命。感染艾滋病毒的吸烟者复吸包括增加接触多种相关压力源感染艾滋病毒，这通常会加剧焦虑/抑郁。拟议的干预措施部分是由以下因素决定的。我们最近完成的 NIDA 资助的 R34 研究项目 (R34DA031038) 取得了成功，其中我们指定并在小型开放试验中进行测试，然后进行试点随机对照试验（RCT）可行性、可接受性为期 9 次的基于认知行为的干预措施（名为“戒烟”）的初步疗效通过特定的情绪脆弱性（焦虑敏感性、痛苦）减少焦虑和抑郁来戒烟这种干预措施专门针对吸烟者而设计。这项研究的结果表明，与常规控制的短暂强化治疗相比。干预 (ETAU) 中，分配至戒断组的患者取得了较高的短期（治疗结束 [EOT]：戒断： 59% vs. ETAU: 9%) 和长期（6 个月随访：戒烟：46% vs. ETAU：5%）戒烟率。9 我们现在我们建议招募 180 名活着的吸烟者进行一项全功率、三组功效/效果试验。设有艾滋病毒实施地点 [(1) 马萨诸塞州总医院传染病诊所 (MGH)，波士顿，(2) 芬威社区健康中心，波士顿，以及 (3) 托马斯街健康中心，休斯顿]。寻求测试戒烟干预措施在增加戒断流行率方面的功效/效果（主要结果），通过减少焦虑和抑郁（次要结果），并确定是否优于主动、可靠的时间匹配控制和标准护理 (SOC) 控制。资源利用和成本效益分析以及第三个 SOC 控制臂支持成本估算如果成功，干预措施将可供翻译研究检验。实施和传播到“现实世界”的健康、心理健康和社会服务环境中。