Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Self-report WTC-related PTSD Symptoms
研究概览
简要总结
Many responders to the World Trade Center (WTC) disaster continue to experience significant mental and physical health problems. Two of the most common health problems, post-traumatic stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and respiratory symptoms.
详细描述
Mind-body interventions including relaxation training and other coping skills are effective for patients with both mental and physical health problems. A leading mind-body treatment is the Relaxation Response Resiliency Program (3RP) developed at Harvard. This treatment has been shown to reduce both mental and physical health symptoms.
The objective of this study is to adapt the 3RP to WTC responders and test its ability to reduce both PTSD and respiratory symptoms. This treatment will be compared to a Health Enhancement Program that addresses negative health behaviors. The investigators will randomly assign 175 patients with ongoing WTC-related PTSD and respiratory illness to the 3RP or Health Enhancement Program and will assess outcomes immediately after the treatment and at 3 and 6 month follow-ups.
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)
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
- •PCL score equal to or greater than 35
- •2 or more lower respiratory symptoms
排除标准
- •Regular elicitation of the relaxation response
- •History of psychosis
- •Current unmanaged bipolar disorder
- •History of suicide attempt --OR-- current ideation with plan or intent
结局指标
主要结局
Self-report WTC-related PTSD Symptoms
时间窗: Change from baseline in WTC-related PTSD symptoms at 6-months
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Clinician Rated WTC-related PTSD Symptoms
时间窗: Change from baseline in WTC-related PTSD symptoms at 6-months
Assessed via clinician interview (SCID for DSM-IV-TR).
次要结局
- Lower Respiratory Symptoms(Change from baseline in lower respiratory symptoms at 6-months)
- Pulmonary Functioning(Change from baseline in pulmonary functioning at 6-months)