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

基本信息

批准号：
10349475
负责人：
Conall Michael O'Cleirigh
金额：
$ 110.88万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-15 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10349475
关键词：
Abstinence Address Adult Affective Anhedonia Anxiety Bacterial Pneumonia Behavioral Biological Assay Boston Caring Cause of Death Chronic Obstructive Pulmonary Disease Clinic Cognitive Cognitive Therapy Communicable Diseases Community Health Cost Effectiveness Analysis Cotinine Counseling Data Disadvantaged Disease Disparity Dissemination and Implementation 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 Treatment Protocols United States World Health antiretroviral therapy anxiety reduction anxiety sensitivity anxiety symptoms arm behavioral health clinically significant cost effectiveness cost estimate depressive symptoms design distress tolerance effectiveness evaluation effectiveness trial efficacy testing experience feasibility trial follow-up health disparity health disparity populations innovation intervention effect male medical specialties negative mood nicotine replacement poor health outcome primary outcome psychological distress secondary outcome sex smoking abstinence smoking cessation smoking intervention smoking prevalence smoking relapse social stigma standard of care stressor success translational study treatment as usual

项目摘要

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.

抽象的尽管过去50年中吸烟的流行率有所下降，但烟草使用中的大量分布留在几个亚组中，特别是处境不利和健康损害的人群。1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满足。2对于艾滋病毒的人，吸烟与较差的生存有关3,4以及遵守抗逆转录病毒治疗的人治疗方案，吸烟比艾滋病毒降低了预期寿命。5–7维护的主要因素的主要因素艾滋病毒感染者中吸烟的救济包括增加了多种压力源与艾滋病毒相关，这种艾滋病毒经常加剧动画/抑郁症。8 我们最近完成的NIDA资助的R34的成功部分告知了拟议的干预措施研究项目（1R34DA031038-01A1）在其中指定并在小型开放试验中进行了测试，然后是飞行员随机对照试验（RCT）9条，认知 - 认知 - 可接受性和初始效率通过减少动画和通过特定的情绪脆弱性（焦虑敏感性，忍受耐受性和Anhedonia）来抑郁。干预措施是专门针对艾滋病毒的吸烟者进行的。这项研究的结果表明，与像往常的控制干预（ETAU）相比，患者相比分配退出的短期（治疗终结[EOT]：退出：59％vs. Etau：9％）和长期术语（6个月的随访：退出：46％vs. Etau：5％）禁欲率。9 现在，我们建议进行全功率，三臂有效性/有效性试验。我们建议注册180 在三个实施部位中患有艾滋病毒的吸烟者[（1）马萨诸塞州传染病诊所综合医院（MGH），波士顿，（2）芬威社区健康，波士顿和（3）托马斯街健康休斯顿中心]。我们试图在增加的位置测试退出干预的有效性/有效性戒酒率（主要结果），减少焦虑和抑郁（次要结果），并确定它是否表现优于主动，可靠的时间匹配的控制和护理标准（SOC）控制。资源利用和成本效益分析的整合以及第三SOC控制臂支持估计成本和有效性。如果成功，干预措施将准备好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中。