NCT01445015Unknown2 期
Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
研究概览
简要总结
The study will utilize a stress management program delivered over 10 sessions that is hypothesized to result in decreased stress levels and improved coping strategies in an inner city adolescent asthma population. Participants will include adolescents ages 10-15 years with physician diagnosed asthma. The outcome measures will be obtained via psychosocial questionnaires and spirometry.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 8-15 years of age
- •Physician diagnosed asthma based on NHBLI guidelines
- •English speaking
- •Child assent/parental consent
排除标准
- •Refusal of child assent/parental consent
- •Non-English speaking
- •History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.
结局指标
主要结局
Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
时间窗: 5 weeks
次要结局
- Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope(5 weeks)
- Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory(5 weeks)
- Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ(5 weeks)
研究者
Lisa Moreno
MD
Weill Medical College of Cornell University
研究点 (2)
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