Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Behavioral Therapy for Insomnia Co-existing With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01973647
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mary C. Kapella, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE October 22, 2013
First Posted Date  ICMJE October 31, 2013
Last Update Posted Date October 2, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Insomnia [ Time Frame: Up to 18 weeks ]
Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
  • Fatigue [ Time Frame: Up to 18 weeks ]
    Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale.
  • Beliefs about sleep [ Time Frame: Up to 18 weeks ]
    Change in beliefs about sleep will be measured using the DBAS questionnaire
  • Sleep habits [ Time Frame: Up to 18 weeks ]
    Change in sleep habits will be measured using a Sleep Diary and Actigraphy
  • Self-efficacy for sleep [ Time Frame: Up to 18 weeks ]
    Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale
  • Self-efficacy for COPD management [ Time Frame: Up to 18 weeks ]
    Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.
  • Emotional arousal [ Time Frame: Up to 18 weeks ]
    Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
  • Inflammation [ Time Frame: 6 weeks ]
    Change in inflammation will be measured using C-reactive protein.
  • Pulmonary function [ Time Frame: 6 weeks ]
    Change in pulmonary function will be measured using pulmonary function tests.
  • Daytime functioning [ Time Frame: Up to 18 weeks ]
    Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Behavioral Therapy for Insomnia Co-existing With COPD
Official Title  ICMJE Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • COPD
  • Chronic Obstructive Pulmonary Disease
  • Fatigue
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
    Six weekly sessions of cognitive behavioral therapy for insomnia
  • Behavioral: COPD Education
    Six weekly sessions of COPD education
  • Behavioral: Attention Control
    Six weekly sessions of non-sleep, non-COPD health education
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy (CBT-I)
    Six weekly sessions of Cognitive Behavioral Therapy for Insomnia
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia
  • Experimental: CBT-I + COPD-ED
    Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy for Insomnia
    • Behavioral: COPD Education
  • Experimental: COPD Education (COPD-ED)
    Six weekly sessions of COPD education
    Intervention: Behavioral: COPD Education
  • Placebo Comparator: Attention Control (AC)
    Six weekly sessions of non-sleep, non-COPD health education
    Intervention: Behavioral: Attention Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2019)
109
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2013)
140
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973647
Other Study ID Numbers  ICMJE 2013-0626
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mary C. Kapella, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary C Kapella, PhD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP