A Behavioral Therapy for Insomnia Co-existing With COPD
- Conditions
- COPDInsomniaChronic Obstructive Pulmonary DiseaseFatigue
- Interventions
- Behavioral: COPD EducationBehavioral: Cognitive Behavioral Therapy for InsomniaBehavioral: Attention Control
- Registration Number
- NCT01973647
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- 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.
Exclusion criteria:
- 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 > 11.
- currently participating in pulmonary rehabilitation.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COPD Education (COPD-ED) COPD Education Six weekly sessions of COPD education Cognitive Behavioral Therapy (CBT-I) Cognitive Behavioral Therapy for Insomnia Six weekly sessions of Cognitive Behavioral Therapy for Insomnia Attention Control (AC) Attention Control Six weekly sessions of non-sleep, non-COPD health education CBT-I + COPD-ED Cognitive Behavioral Therapy for Insomnia Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education CBT-I + COPD-ED COPD Education Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education
- Primary Outcome Measures
Name Time Method Insomnia Up to 18 weeks Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.
- Secondary Outcome Measures
Name Time Method Beliefs about sleep Up to 18 weeks Change in beliefs about sleep will be measured using the DBAS questionnaire
Inflammation 6 weeks Change in inflammation will be measured using C-reactive protein.
Fatigue Up to 18 weeks Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale.
Sleep habits Up to 18 weeks Change in sleep habits will be measured using a Sleep Diary and Actigraphy
Self-efficacy for sleep Up to 18 weeks Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale
Pulmonary function 6 weeks Change in pulmonary function will be measured using pulmonary function tests.
Self-efficacy for COPD management Up to 18 weeks Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.
Emotional arousal Up to 18 weeks Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
Daytime functioning Up to 18 weeks Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale.
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States