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.

尽管过去50年中吸烟的流行率有所下降，但烟草使用中的大量分布 仍在几个亚组中，特别是处境不利和健康损害人群。吸烟者 艾滋病毒感染者代表着美国和世界的主要健康差异人群 通常，他们独特的医疗保健需求没有得到充分解决。对于感染艾滋病毒的人 吸烟与较差的生存有关，在遵守抗逆转录病毒治疗的人中 疗法，吸烟比艾滋病毒降低了预期寿命。维护和 艾滋病毒感染者吸烟者的吸烟复发包括增加与与多种压力源相关的暴露 艾滋病毒通常会加剧焦虑/抑郁症。拟议的干预措施部分由 我们最近完成的NIDA资助的R34研究项目（R34DA031038）的成功 并在一项小型开放试验中进行了测试，然后进行了飞行员随机对照试验（RCT）的可行性，可接受性 以及9条经验，基于认知行为的干预措施（命名为退出）的初始效率以解决吸烟 通过特定的情绪脆弱性（焦虑敏感性，困扰）来减轻焦虑和抑郁来停止 宽容和阿尼奥尼亚）。这种干预措施是专门适应的，专为与之生活的吸烟者设计 艾滋病病毒。这项研究的结果表明，与像往常一样的短暂增强治疗相比 干预（ETAU），分配退出的患者达到了较高的短期（治疗终结[EOT]：退出： 59％vs. Etau：9％）和长期（6个月的随访：退出：46％vs. Etau：5％）的禁欲率。9我们现在 提案进行全功率，三臂有效性/有效性试验。我们建议注册180名居住的吸烟者 在三个实施部位中艾滋病毒[（1）马萨诸塞州综合医院传染病诊所 （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 寻求在增加的戒酒中测试退出干预的有效性/有效性 （主要结果），减少焦虑和抑郁（次要结果），并确定是否 优于主动，可信的时间匹配的控制和护理标准（SOC）控制。整合 资源利用率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，干预措施将准备好进行翻译研究 实施并传播到“现实世界”的健康，心理健康和社会服务环境中。