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Clinical Trials/NCT01973647
NCT01973647CompletedNot Applicable

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

University of Illinois at Chicago2 sites in 1 country109 target enrollmentStarted: June 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
109
Locations
2
Primary Endpoint
Insomnia

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 >
  • currently participating in pulmonary rehabilitation.

Exclusion Criteria

  • Not provided

Arms & Interventions

Cognitive Behavioral Therapy (CBT-I)

Experimental

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia

Intervention: Cognitive Behavioral Therapy for Insomnia (Behavioral)

CBT-I + COPD-ED

Experimental

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

Intervention: Cognitive Behavioral Therapy for Insomnia (Behavioral)

CBT-I + COPD-ED

Experimental

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

Intervention: COPD Education (Behavioral)

COPD Education (COPD-ED)

Experimental

Six weekly sessions of COPD education

Intervention: COPD Education (Behavioral)

Attention Control (AC)

Placebo Comparator

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

Intervention: Attention Control (Behavioral)

Outcomes

Primary Outcomes

Insomnia

Time Frame: Up to 18 weeks

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

Secondary Outcomes

  • Beliefs about sleep(Up to 18 weeks)
  • Inflammation(6 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary C. Kapella

Associate Professor

University of Illinois at Chicago

Study Sites (2)

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