Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic ob- structive 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 ac- tion of such a therapy are yet unclear in people with COPD. Lack of such knowledge is an important problem, because without it, health care providers will remain ill-equipped to manage patients with both COPD and in- somnia. The long-term goal is to help develop safe and effective non-pharmacological interventions to mini- mize insomnia and its consequences in people with COPD. The objective here is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting in- somnia 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 insomnia and fatigue. This hypothesis is consistent with preliminary data produced by the applicant. 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 can be developed to nonpharmacologically minimize insomnia and fatigue, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to insomnia. Guided by strong preliminary data, the central hypothesis will be tested using a randomized controlled parallel-groups 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 proposed re- search is a significant, necessary step in the development of effective non-pharmacologic therapies for insom- nia coexisting with COPD. The work proposed in Aims 1 and 2 will provide systematic evidence of efficacy and mechanisms of components of a novel approach to insomnia coexisting with COPD. Results are expected to have great public health significance and positive impact because the identified mechanisms are highly likely to provide new approaches for preventive and therapeutic interventions for insomnia and fatigue in COPD.
The proposed research is relevant to public health because knowledge of efficacy and mechanisms of components of cognitive behavioral therapy for insomnia in COPD is highly likely to provide new approaches for preventive and therapeutic interventions for insomnia and fatigue in COPD. Thus, the proposed research is relevant to the part of NIH's mission that pertains to developing knowledge about behavior to enhance health, lengthen life, and reduce the burdens of illness and disability.
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