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

• 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
• 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

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.

虽然吸烟的流行率在过去50年中有所下降，但烟草使用的巨大差异 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。吸烟者 艾滋病毒感染者是美国和世界上一个主要的健康差距人口。 一般来说，他们独特的医疗保健需求没有得到充分解决。对于艾滋病毒感染者， 吸烟与较差的生存率有关， 吸烟比艾滋病毒更能降低预期寿命。维护和保养的主要因素 感染艾滋病毒的吸烟者复吸的风险包括更多地暴露于与吸烟有关的多种压力因素， 艾滋病毒感染者，这往往会加剧焦虑/抑郁。拟议的干预措施部分是由 我们最近完成的NIDA资助的R34研究项目（R34 DA 031038）的成功，我们指定 并在小型开放试验中进行了验证，然后进行了先导性随机对照试验（RCT）， 9个疗程的基于认知行为的干预（名为QUIT）解决吸烟问题的初步疗效 通过特定的情绪脆弱性（焦虑敏感性、痛苦）减少焦虑和抑郁， 耐受性和快感缺乏）。这项干预措施是专门为吸烟者设计的， 艾滋病。这项研究的结果表明，与常规对照组相比， 干预（ETAU），分配至QUIT组的患者实现了更高的短期（治疗结束[EOT]：QUIT： 59% vs. ETAU：9%）和长期（6个月随访：退出：46% vs. ETAU：5%）戒烟率。 建议进行一项充分把握度的3组疗效/有效性试验。我们建议招募180名吸烟者， 在三个实施地点[（1）传染病诊所，马萨诸塞州总医院 (MGH)，波士顿，（2）芬威社区健康，波士顿，和（3）托马斯街健康中心，休斯顿]。我们 试图测试QUIT干预在增加点流行率禁欲的功效/有效性 （主要结果），通过减少焦虑和抑郁（次要结果），并确定它是否 优于主动、可靠的时间匹配控制和标准护理（SOC）控制。的整合 资源利用和成本效益分析以及第三SOC控制臂支持成本估算 和有效性。如果成功的话，这种干预措施将为翻译研究做好准备 实施和传播到“现实世界”的健康、心理健康和社会服务环境。