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临床试验/NCT01973647
NCT01973647已完成不适用

Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
1
主要终点
Insomnia

研究概览

简要总结

Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.

详细描述

The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •mild to very severe COPD.
  • •age ≥ 45 years of age with no other major healthproblems.
  • •clinically stable at the time of enrollment into the study.
  • •insomnia.

排除标准

  • •evidence of restrictive lung disease or asthma.
  • •pulse oximetry reading of < 90% at rest or < 85% at night for > 5 min.
  • •evidence of a major sleep disorder other than insomnia.
  • •hypnotic use.
  • •acute respiratory infection within the previous 2 months.
  • •presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
  • •a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of >
  • •currently participating in pulmonary rehabilitation.

研究组 & 干预措施

Cognitive Behavioral Therapy (CBT-I)

Experimental

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia

干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)

CBT-I + COPD-ED

Experimental

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education

干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)

CBT-I + COPD-ED

Experimental

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education

干预措施: COPD Education (Behavioral)

COPD Education (COPD-ED)

Experimental

Six weekly sessions of COPD education

干预措施: COPD Education (Behavioral)

Attention Control (AC)

Placebo Comparator

Six weekly sessions of non-sleep, non-COPD health education

干预措施: Attention Control (Behavioral)

结局指标

主要结局

Insomnia

时间窗: Up to 18 weeks

Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.

次要结局

  • Inflammation(6 weeks)
  • Beliefs about sleep(Up to 18 weeks)
  • Fatigue(Up to 18 weeks)
  • Sleep habits(Up to 18 weeks)
  • Self-efficacy for sleep(Up to 18 weeks)
  • Pulmonary function(6 weeks)
  • Self-efficacy for COPD management(Up to 18 weeks)
  • Emotional arousal(Up to 18 weeks)
  • Daytime functioning(Up to 18 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary C. Kapella

Associate Professor

University of Illinois at Chicago

研究点 (1)

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