A Behavioral Therapy for Insomnia Co-existing With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973647
• Other study ID #: 2013-0626
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2019

Study information

• Verified date: September 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Fatigue
• Insomnia
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia
Six weekly sessions of cognitive behavioral therapy for insomnia
• COPD Education
Six weekly sessions of COPD education
• Attention Control
Six weekly sessions of non-sleep, non-COPD health education

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia	Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.	Up to 18 weeks
Secondary	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
Secondary	Beliefs about sleep	Change in beliefs about sleep will be measured using the DBAS questionnaire	Up to 18 weeks
Secondary	Sleep habits	Change in sleep habits will be measured using a Sleep Diary and Actigraphy	Up to 18 weeks
Secondary	Self-efficacy for sleep	Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale	Up to 18 weeks
Secondary	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
Secondary	Emotional arousal	Change in emotional arousal will be measured using the PROMIS anxiety and depression scales	Up to 18 weeks
Secondary	Inflammation	Change in inflammation will be measured using C-reactive protein.	6 weeks
Secondary	Pulmonary function	Change in pulmonary function will be measured using pulmonary function tests.	6 weeks
Secondary	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