- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01973647
A Behavioral Therapy for Insomnia Co-existing With COPD
27 september 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
109
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois at Chicago
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cognitive Behavioral Therapy (CBT-I)
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia
|
Six weekly sessions of cognitive behavioral therapy for insomnia
|
|
Experimenteel: CBT-I + COPD-ED
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education
|
Six weekly sessions of cognitive behavioral therapy for insomnia
Six weekly sessions of COPD education
|
|
Experimenteel: COPD Education (COPD-ED)
Six weekly sessions of COPD education
|
Six weekly sessions of COPD education
|
|
Placebo-vergelijker: Attention Control (AC)
Six weekly sessions of non-sleep, non-COPD health education
|
Six weekly sessions of non-sleep, non-COPD health education
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Insomnia
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fatigue
Tijdsspanne: 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.
|
Up to 18 weeks
|
|
Beliefs about sleep
Tijdsspanne: Up to 18 weeks
|
Change in beliefs about sleep will be measured using the DBAS questionnaire
|
Up to 18 weeks
|
|
Sleep habits
Tijdsspanne: Up to 18 weeks
|
Change in sleep habits will be measured using a Sleep Diary and Actigraphy
|
Up to 18 weeks
|
|
Self-efficacy for sleep
Tijdsspanne: Up to 18 weeks
|
Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale
|
Up to 18 weeks
|
|
Self-efficacy for COPD management
Tijdsspanne: Up to 18 weeks
|
Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.
|
Up to 18 weeks
|
|
Emotional arousal
Tijdsspanne: Up to 18 weeks
|
Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
|
Up to 18 weeks
|
|
Inflammation
Tijdsspanne: 6 weeks
|
Change in inflammation will be measured using C-reactive protein.
|
6 weeks
|
|
Pulmonary function
Tijdsspanne: 6 weeks
|
Change in pulmonary function will be measured using pulmonary function tests.
|
6 weeks
|
|
Daytime functioning
Tijdsspanne: 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.
|
Up to 18 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Mary C Kapella, PhD, University of Illinois at Chicago
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2014
Primaire voltooiing (Werkelijk)
1 juli 2019
Studie voltooiing (Werkelijk)
1 juli 2019
Studieregistratiedata
Eerst ingediend
22 oktober 2013
Eerst ingediend dat voldeed aan de QC-criteria
25 oktober 2013
Eerst geplaatst (Schatting)
31 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 oktober 2019
Laatste update ingediend die voldeed aan QC-criteria
27 september 2019
Laatst geverifieerd
1 september 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2013-0626
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .