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

综合治疗解决艾滋病毒感染者戒烟和焦虑/抑郁问题的有效性

• 批准号: 9925766
• 负责人: Conall Michael O'Cleirigh
• 金额: $ 106.05万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-15 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9925766
• 关键词: Abstinence; Address; Adult; Affective; Anhedonia; Anxiety; Bacterial Pneumonia; Behavioral; Biological; Biological Assay; Boston; Caring; Cause of Death; Chronic Obstructive Airway Disease; Clinic; Cognitive; Cognitive Therapy; Communicable Diseases; Community Health; Cost Effectiveness Analysis; Cotinine; Counseling; Data; Depressive disorder; Disadvantaged; Distress; Effectiveness; Emotional; Enrollment; Exposure to; Female; Funding; General Hospitals; HIV; Health; Health Status; Healthcare; Human immunodeficiency virus test; Hybrids; Impaired cognition; Individual; Intervention; Life Expectancy; Longterm Follow-up; Maintenance; Malignant neoplasm of lung; Massachusetts; Mediating; Mental Depression; Mental Health Services; Moods; Names; National Institute of Drug Abuse; Outcome; Patients; Persons; Pharmacotherapy; Population; Predisposition; Prevalence; Process; Public Health; Randomized; Randomized Controlled Trials; Research Personnel; Research Project Grants; Resources; Sampling; Service setting; Severities; Site; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Social Work; Specific qualifier value; Subgroup; Testing; Time; Tobacco; Tobacco use; Translations; Treatment Protocols; United States; World Health; antiretroviral therapy; anxiety sensitivity; anxiety symptoms; arm; base; behavioral health; clinically significant; cost effectiveness; cost estimate; depressive symptoms; design; distress tolerance; effectiveness trial; efficacy testing; experience; feasibility trial; follow-up; health disparity; innovation; intervention effect; male; medical specialties; negative mood; nicotine replacement; primary outcome; psychological distress; secondary outcome; sex; smoking abstinence; smoking cessation; smoking intervention; smoking prevalence; smoking relapse; social stigma; standard of care; stressor; success; successful intervention; treatment as usual

ABSTRACT 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.1 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.2 For people living with HIV, smoking is related to poorer survival3,4 and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV.5–7 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.8 The proposed intervention is informed, in part, by the success of our recently completed NIDA-funded R34 research project (1R34DA031038-01A1) 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.

摘要 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 在几个亚群体中，特别是弱势群体和健康受损群体中，吸烟者的比例仍然很高。 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。2对于艾滋病毒感染者， 吸烟与较差的生存率有关3，4，在坚持抗逆转录病毒治疗的人中， 吸烟对预期寿命的影响大于艾滋病毒。5 -7维持健康的主要因素 感染艾滋病毒的吸烟者吸烟和复吸的风险包括增加对多种压力因素的暴露 与艾滋病毒有关的疾病，这往往会加剧焦虑/抑郁。 建议的干预措施部分是由我们最近完成的NIDA资助的R34的成功所告知的。 研究项目（1 R34 DA 031038 - 01 A1），我们在一个小型开放试验中进行了规定和测试，然后进行了试点 随机对照试验（RCT）的可行性，可接受性和初步疗效的9个会议，认知- 基于行为的干预（名为QUIT），通过减少焦虑和 抑郁症通过特定的情绪脆弱性（焦虑敏感性，痛苦容忍度和快感缺乏）。这 干预措施是专门为感染艾滋病毒的吸烟者调整和设计的。本研究的结果 结果显示，与常规对照干预（ETAU）相比， 分配至QUIT组的受试者获得了更高的短期（治疗结束[EOT]：QUIT：59% vs. ETAU：9%）和长期- 长期（6个月随访：退出：46% vs. ETAU：5%）戒烟率。9 我们现在建议进行一项充分把握度的3组疗效/有效性试验。我们计划招收180名学生 三个实施地点的艾滋病毒感染者[（1）传染病诊所，马萨诸塞州 波士顿综合医院（MGH），（2）波士顿芬威社区健康中心，和（3）托马斯街健康中心 Center，Houston].我们寻求在增加的点上测试QUIT干预的功效/有效性 通过减少焦虑和抑郁（次要结局）， 确定其是否优于主动、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 成本和效益的估计。如果成功，干预措施将准备翻译研究， 检查实施和传播到“现实世界”的健康，心理健康和社会服务环境。