- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01973647
A Behavioral Therapy for Insomnia Co-existing With COPD
27. september 2019 opdateret af: Mary C. Kapella, University of Illinois at Chicago
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
109
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Cognitive Behavioral Therapy (CBT-I)
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia
|
Six weekly sessions of cognitive behavioral therapy for insomnia
|
Eksperimentel: CBT-I + COPD-ED
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education
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Six weekly sessions of cognitive behavioral therapy for insomnia
Six weekly sessions of COPD education
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Eksperimentel: COPD Education (COPD-ED)
Six weekly sessions of COPD education
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Six weekly sessions of COPD education
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Placebo komparator: Attention Control (AC)
Six weekly sessions of non-sleep, non-COPD health education
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Six weekly sessions of non-sleep, non-COPD health education
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Insomnia
Tidsramme: Up to 18 weeks
|
Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.
|
Up to 18 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fatigue
Tidsramme: 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.
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Up to 18 weeks
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Beliefs about sleep
Tidsramme: Up to 18 weeks
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Change in beliefs about sleep will be measured using the DBAS questionnaire
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Up to 18 weeks
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Sleep habits
Tidsramme: Up to 18 weeks
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Change in sleep habits will be measured using a Sleep Diary and Actigraphy
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Up to 18 weeks
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Self-efficacy for sleep
Tidsramme: Up to 18 weeks
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Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale
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Up to 18 weeks
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Self-efficacy for COPD management
Tidsramme: Up to 18 weeks
|
Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.
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Up to 18 weeks
|
Emotional arousal
Tidsramme: Up to 18 weeks
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Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
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Up to 18 weeks
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Inflammation
Tidsramme: 6 weeks
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Change in inflammation will be measured using C-reactive protein.
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6 weeks
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Pulmonary function
Tidsramme: 6 weeks
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Change in pulmonary function will be measured using pulmonary function tests.
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6 weeks
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Daytime functioning
Tidsramme: Up to 18 weeks
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Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale.
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Up to 18 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Mary C Kapella, PhD, University of Illinois at Chicago
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2014
Primær færdiggørelse (Faktiske)
1. juli 2019
Studieafslutning (Faktiske)
1. juli 2019
Datoer for studieregistrering
Først indsendt
22. oktober 2013
Først indsendt, der opfyldte QC-kriterier
25. oktober 2013
Først opslået (Skøn)
31. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013-0626
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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