A Behavioral Therapy for Insomnia Co-existing With COPD



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Insomnia Sleep Studies, Other Indications, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:45 - Any
Updated:5/12/2018
Start Date:June 2014
End Date:July 2019
Contact:Mary C Kapella, PhD
Email:mkapel1@uic.edu
Phone:312-355-3150

Use our guide to learn which trials are right for you!

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

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.

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.

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 > 11.

- currently participating in pulmonary rehabilitation.
We found this trial at
1
site
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Mary C Kapella, PhD
Phone: 312-996-9542
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials