Evaluating the Effectiveness of an Integrated Intervention for WTC Workers With PTSD and Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
Asthma and post-traumatic stress disorder (PTSD) are the most common conditions in World Trade Center (WTC) rescue and recovery workers. In this study, the study team will evaluate the interplay of biological and behavioral mechanisms explaining the relationship of PTSD with increase asthma morbidity and adapt and pilot test a novel intervention to improve outcomes of WTC workers.
详细描述
Significance: Importance of the Problem: Multiple studies have shown a high prevalence of asthma in WTC rescue and recovery workers, local residents, and passersby. Using data from the National Health Interview Survey (NHIS), the study team found that WTC workers have twice the risk of asthma compared to the general United States (US) population. Data from the WTCHP shows a 28% cumulative incidence of asthma 9 years after September 11, 2001 among WTC workers. These studies show that asthma is the most prevalent respiratory condition among WTC rescue and recovery workers.
WTC workers with asthma include individuals with prior history of the disease and new cases of irritant-induced asthma. Many workers with preexistent asthma developed worsening symptoms after WTC-related exposures (WTC-exacerbated asthma). Other workers developed new asthma symptoms without latency during or after WTC exposure and were diagnosed with irritant-induced asthma. Multiple cases of new onset asthma among WTC workers have been reported in the years following exposure to the WTC site; characterization of these cases has been more difficult. Despite this potential heterogeneity, these conditions are frequently grouped in clinical practice as WTC-related asthma and managed similarly.
Studies found substantial burden of asthma morbidity in WTC workers and exposed community members, with reports of poorly-controlled in 34% and very poorly-controlled symptoms in 35% of exposed individuals. Increased risk of emergency department (ED) visits and hospitalizations as well as poor quality of life in WTC workers with asthma have been reported, showing a major impact on health.
Scientific Premise of Project: PTSD is Associated with Increased Asthma Morbidity in WTC Workers: Prevalence of psychological symptoms in WTC-exposed populations is high; with PTSD reported as the most common (~30%) mental health condition. Studies have also found high rates (25-35%) of PTSD comorbidity in WTC workers with asthma. Mental health conditions and PTSD in particular, have been associated with increased asthma morbidity. The study team found that WTC workers with PTSD had worse asthma control, increased healthcare use, and poorer quality of life.
. Similarly, a study of WTC workers indicated that severity of PTSD symptoms predicted new onset and worsening of asthma. Data from studies in the general population have also shown that PTSD is associated with higher asthma morbidity. In summary, studies have documented a high level of overlap between asthma and PTSD in WTC workers and other exposed populations and have documented that PTSD is a major contributor to increased asthma morbidity. However, the underlying mechanisms explaining this relationship remain unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research coordinators (RCs) are blinded to study randomization and treatment arm for each participant.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PTSD based on SCID or PCL-5
- •Poorly controlled asthma based on ACQ score ≥1.5
- •Completion of observational study 12-month visit
排除标准
- •Active Suicidal Ideation
- •Co-existence of COPD or other chronic respiratory illnesses
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months
The PTSD Checklist for DSM-5 (PCL-5), is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Full range from 0-80, higher score indicates more symptoms.
次要结局
- Asthma Control Questionnaire (ACQ)(Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months)
- Illness Perception Questionnaire (IPQ)(Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months)
- Asthma Quality of Life Questionnaire (AQLQ)(Baseline, 1 week post-intervention, 3 months post-intervention)
- Medication Adherence Report Scale (MARS)(Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months)
- Beliefs About Medicines Questionnaire (BMQ)(Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months)
- Patient Health Questionnaire-9 (PHQ-9) Depression Severity(Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months)
- Generalized Anxiety Disorder-7(Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months)
研究者
Juan P Wisnivesky
Professor
Icahn School of Medicine at Mount Sinai
