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A Behavioral Therapy for Insomnia Co-existing With COPD

27. september 2019 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

109

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois at Chicago

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cognitive Behavioral Therapy (CBT-I)
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia
Six weekly sessions of cognitive behavioral therapy for insomnia
Eksperimentell: 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
Eksperimentell: COPD Education (COPD-ED)
Six weekly sessions of COPD education
Six weekly sessions of COPD education
Placebo komparator: Attention Control (AC)
Six weekly sessions of non-sleep, non-COPD health education
Six weekly sessions of non-sleep, non-COPD health education

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.
Up to 18 weeks
Beliefs about sleep
Tidsramme: Up to 18 weeks
Change in beliefs about sleep will be measured using the DBAS questionnaire
Up to 18 weeks
Sleep habits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 18 weeks
Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
Up to 18 weeks
Inflammation
Tidsramme: 6 weeks
Change in inflammation will be measured using C-reactive protein.
6 weeks
Pulmonary function
Tidsramme: 6 weeks
Change in pulmonary function will be measured using pulmonary function tests.
6 weeks
Daytime functioning
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mary C Kapella, PhD, University of Illinois at Chicago

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2014

Primær fullføring (Faktiske)

1. juli 2019

Studiet fullført (Faktiske)

1. juli 2019

Datoer for studieregistrering

Først innsendt

22. oktober 2013

Først innsendt som oppfylte QC-kriteriene

25. oktober 2013

Først lagt ut (Anslag)

31. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. september 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

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