InsomniaNCT01973647
A Behavioral Therapy for Insomnia Co-existing With COPD
A study testing Cognitive Behavioral Therapy for Insomnia and COPD Education in people with Insomnia and COPD, run by University of Illinois at Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Insomnia, COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and COPD Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia, COPD, Chronic Obstructive Pulmonary Disease, Fatigue
- Being tested
- Cognitive Behavioral Therapy for Insomnia, COPD Education, Attention Control
- Keywords
- insomnia, cognitive behavioral therapy, COPD, fatigue
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pulmonary Disease, Chronic Obstructive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Six weekly sessions of cognitive behavioral therapy for insomnia
COPD EducationBehavioural
Six weekly sessions of COPD education
Attention ControlBehavioural
Six weekly sessions of non-sleep, non-COPD health education
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT-I) | Experimental | Six weekly sessions of Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| CBT-I + COPD-ED | Experimental | Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: COPD Education |
| COPD Education (COPD-ED) | Experimental | Six weekly sessions of COPD education Receives: Behavioral: COPD Education |
| Attention Control (AC) | Placebo comparator | Six weekly sessions of non-sleep, non-COPD health education Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia
Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.
Measured: Up to 18 weeks
Secondary outcomes (9)
Fatigue
Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale.
Measured: Up to 18 weeks
Beliefs about sleep
Change in beliefs about sleep will be measured using the DBAS questionnaire
Measured: Up to 18 weeks
Sleep habits
Change in sleep habits will be measured using a Sleep Diary and Actigraphy
Measured: Up to 18 weeks
Self-efficacy for sleep
Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale
Measured: 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.
Measured: Up to 18 weeks
Emotional arousal
Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
Measured: Up to 18 weeks
Inflammation
Change in inflammation will be measured using C-reactive protein.
Measured: 6 weeks
Pulmonary function
Change in pulmonary function will be measured using pulmonary function tests.
Measured: 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.
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJun 2014
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary C. Kapella, University of Illinois at Chicago
- Investigators
- Mary C Kapella, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973647
- Sponsor's protocol ID
- 2013-0626
- Status last verified
- Sep 2019
- First submitted
- 22 Oct 2013
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 22162648Jun J, Park C, Fritschi C, Balserak B, Martyn-Nemeth P, Kuna S, Kapella M. Behavioral interventions and symptom cluster change in adults with chronic obstructive pulmonary disease and insomnia. Heart Lung. 2024 Mar-Apr;64:6-13. doi: 10.1016/j.hrtlng.2023.11.001. Epub 2023 Nov 15.
PubMed 37976563Kapella 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.
PubMed 35946416Kapella 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.
PubMed 27215949
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
- ClinicalTrials.gov ID
- NCT01973647
- Acronym / sponsor ID
- 2013-0626
- Conditions
- Insomnia, COPD, Chronic Obstructive Pulmonary Disease, Fatigue
- Keywords
- insomnia, cognitive behavioral therapy, COPD, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT-I) | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaSix weekly sessions of Cognitive Behavioral Therapy for Insomnia |
| CBT-I + COPD-ED | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: COPD EducationSix weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education |
| COPD Education (COPD-ED) | Experimental | Behavioral: COPD EducationSix weekly sessions of COPD education |
| Attention Control (AC) | Placebo comparator | Behavioral: Attention ControlSix weekly sessions of non-sleep, non-COPD health education |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaSix weekly sessions of cognitive behavioral therapy for insomnia | Behavioural | CBT-I + COPD-ED, Cognitive Behavioral Therapy (CBT-I) |
| COPD EducationSix weekly sessions of COPD education | Behavioural | CBT-I + COPD-ED, COPD Education (COPD-ED) |
| Attention ControlSix weekly sessions of non-sleep, non-COPD health education | Behavioural | Attention Control (AC) |
Primary outcome
Insomnia
Time frame: Up to 18 weeks
Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.
9 secondary outcomes
Fatigue
Time frame: Up to 18 weeks
Beliefs about sleep
Time frame: Up to 18 weeks
Sleep habits
Time frame: Up to 18 weeks
Self-efficacy for sleep
Time frame: Up to 18 weeks
Self-efficacy for COPD management
Time frame: Up to 18 weeks
Emotional arousal
Time frame: Up to 18 weeks
Inflammation
Time frame: 6 weeks
Pulmonary function
Time frame: 6 weeks
Daytime functioning
Time frame: Up to 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 22162648Kapella 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.
- Derived from this study: PubMed 37976563Jun J, Park C, Fritschi C, Balserak B, Martyn-Nemeth P, Kuna S, Kapella M. Behavioral interventions and symptom cluster change in adults with chronic obstructive pulmonary disease and insomnia. Heart Lung. 2024 Mar-Apr;64:6-13. doi: 10.1016/j.hrtlng.2023.11.001. Epub 2023 Nov 15.
- Derived from this study: PubMed 35946416Kapella 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.
- Derived from this study: PubMed 27215949Kapella 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.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary C Kapella, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia and COPD Education in people with Insomnia and COPD, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia (time frame: Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973647, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.