A Behavioral Therapy for Insomnia Co-existing With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia COPD Chronic Obstructive Pulmonary Disease Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Behavioral Therapy (CBT-I)

Six weekly sessions of Cognitive Behavioral Therapy for Insomnia

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Six weekly sessions of cognitive behavioral therapy for insomnia

CBT-I + COPD-ED

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Six weekly sessions of cognitive behavioral therapy for insomnia

COPD Education

Intervention Type BEHAVIORAL

Six weekly sessions of COPD education

COPD Education (COPD-ED)

Six weekly sessions of COPD education

Group Type EXPERIMENTAL

COPD Education

Intervention Type BEHAVIORAL

Six weekly sessions of COPD education

Attention Control (AC)

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

Group Type PLACEBO_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Behavioral Therapy for Insomnia

Six weekly sessions of cognitive behavioral therapy for insomnia

Intervention Type BEHAVIORAL

COPD Education

Six weekly sessions of COPD education

Intervention Type BEHAVIORAL

Attention Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No