A Behavioral Therapy for Insomnia Co-existing With COPD

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Chronic Obstructive Pulmonary Disease; Insomnia; COPD
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: COPD Education; Behavioral: Attention Control

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy (CBT-I); Six weekly sessions of Cognitive Behavioral Therapy for Insomnia	Behavioral: Cognitive Behavioral Therapy for Insomnia; Six weekly sessions of cognitive behavioral therapy for insomnia
Experimental: CBT-I + COPD-ED; Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education	Behavioral: Cognitive Behavioral Therapy for Insomnia; Six weekly sessions of cognitive behavioral therapy for insomnia; Behavioral: COPD Education; Six weekly sessions of COPD education
Experimental: COPD Education (COPD-ED); Six weekly sessions of COPD education	Behavioral: COPD Education; Six weekly sessions of COPD education
Placebo Comparator: Attention Control (AC); Six weekly sessions of non-sleep, non-COPD health education	Behavioral: Attention Control; Six weekly sessions of non-sleep, non-COPD health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia	Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.	Up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale.	Up to 18 weeks
Beliefs about sleep	Change in beliefs about sleep will be measured using the DBAS questionnaire	Up to 18 weeks
Sleep habits	Change in sleep habits will be measured using a Sleep Diary and Actigraphy	Up to 18 weeks
Self-efficacy for sleep	Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale	Up to 18 weeks
Self-efficacy for COPD management	Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.	Up to 18 weeks
Emotional arousal	Change in emotional arousal will be measured using the PROMIS anxiety and depression scales	Up to 18 weeks
Inflammation	Change in inflammation will be measured using C-reactive protein.	6 weeks
Pulmonary function	Change in pulmonary function will be measured using pulmonary function tests.	6 weeks
Daytime functioning	Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale.	Up to 18 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Mary C Kapella, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• Kapella MC, Herdegen JJ, Perlis ML, Shaver JL, Larson JL, Law JA, Carley DW. Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. Int J Chron Obstruct Pulmon Dis. 2011;6:625-35. doi: 10.2147/COPD.S24858. Epub 2011 Nov 24.
• Kapella M, Steffen A, Prasad B, Laghi F, Vispute S, Kemner G, Teixeira C, Peters T, Jun J, Law J, Carley D. Therapy for insomnia with chronic obstructive pulmonary disease: a randomized trial of components. J Clin Sleep Med. 2022 Dec 1;18(12):2763-2774. doi: 10.5664/jcsm.10210.
• Kapella MC, Herdegen JJ, Laghi F, Steffen AD, Carley DW. Efficacy and mechanisms of behavioral therapy components for insomnia coexisting with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2016 May 23;17(1):258. doi: 10.1186/s13063-016-1334-0.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: fatigue; COPD; insomnia; cognitive behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Fatigue; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2013-0626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO