Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)
30. juli 2012 oppdatert av: Uppsala University
Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach.
The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL).
Following an active treatment-control period, the control group were re-assigned to CBT.
The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group.
Primary outcome measure was a brief self-report screening form, Insomnia severity index.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
66
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Uppsala, Sverige, 75105
- Uppsala University
-
-
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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Fulfilled research criteria for chronic insomnia
Exclusion Criteria:
- other untreated sleep disturbance
- pregnancy
- shift work
- concurrent medical or psychiatric condition that could be negatively affected by the treatment
- drug abuse
- severe depression
- dementia
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CBT
The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel.
Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
|
Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
|
|
Ingen inngripen: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in the Insomnia severity index (ISI)
Tidsramme: After 9 weeks
|
A brief self-report screening form
|
After 9 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in sleep-onset latency (SOL)
Tidsramme: 9 weeks
|
Time to fall asleep, measured with sleep diary
|
9 weeks
|
|
Change from baseline in wake time after sleep onset (WASO)
Tidsramme: After 9 weeks
|
Time awake during the night, measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in number of awakenings during the night (NWAK)
Tidsramme: After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in Sleep efficiency (SE)
Tidsramme: After 9 weeks
|
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in time in bed (TIB)
Tidsramme: After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in total sleep time (TST)
Tidsramme: After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in sleep quality (SQ)
Tidsramme: After 9 weeks
|
Subjective sleep quality (likert scale)
|
After 9 weeks
|
|
Change from baseline in the fatigue severity scale (FSS)
Tidsramme: After 9 weeks
|
Self-report questionnaire
|
After 9 weeks
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
Tidsramme: After 9 weeks
|
Questionnaire assessing physical and mental health
|
After 9 weeks
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
Tidsramme: After 9 weeks
|
Self-report questionnaire measuring depression and anxiety
|
After 9 weeks
|
|
Change from baseline in the Epworth sleepiness scale, ESS
Tidsramme: After 9 weeks
|
Self-report questionnaire assessing daytime sleepiness
|
After 9 weeks
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Tidsramme: After 9 weeks
|
Self-report form assessing sleep quality
|
After 9 weeks
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
Tidsramme: After 9 weeks
|
Ultra short screening questionnaire for insomnia
|
After 9 weeks
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
Tidsramme: After 9 weeks
|
A questionnaire intended to assess acceptance of insomnia
|
After 9 weeks
|
|
Change from baseline in Body mass index
Tidsramme: After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in sagittal abdominal diameter
Tidsramme: After 9 weeks
|
Abdominal height (cm)
|
After 9 weeks
|
|
Change from baseline in waist-hip ratio
Tidsramme: After 9 weeks
|
A ratio of the circumference of the waist to the hips
|
After 9 weeks
|
|
Change from baseline in blood pressure
Tidsramme: After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in heart rate
Tidsramme: After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in ALAT
Tidsramme: After 9 weeks
|
Liver function
|
After 9 weeks
|
|
Change from baseline in HbA 1c
Tidsramme: After 9 weeks
|
Glycated hemoglobin
|
After 9 weeks
|
|
Change from baseline in blood glucose
Tidsramme: After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in triglycerides
Tidsramme: After 9 weeks
|
A type of fat found in the blood
|
After 9 weeks
|
|
Change from baseline in cholesterol (LDL/HDL)
Tidsramme: After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in sleep-onset latency (SOL)
Tidsramme: After 18 months
|
Time to fall asleep, measured with sleep diary
|
After 18 months
|
|
Change from baseline in wake time after sleep onset (WASO)
Tidsramme: After 18 months
|
Time awake during the night, measured with sleep diary
|
After 18 months
|
|
Change from baseline in number of awakenings during the night (NWAK)
Tidsramme: After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in Sleep efficiency (SE)
Tidsramme: After 18 months
|
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
|
After 18 months
|
|
Change from baseline in time in bed (TIB)
Tidsramme: After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in total sleep time (TST)
Tidsramme: After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in sleep quality (SQ)
Tidsramme: After 18 months
|
Subjective sleep quality (likert scale)
|
After 18 months
|
|
Change from baseline in the fatigue severity scale (FSS)
Tidsramme: After 18 months
|
Self-report questionnaire
|
After 18 months
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
Tidsramme: After 18 months
|
Questionnaire assessing physical and mental health
|
After 18 months
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
Tidsramme: After 18 months
|
Self-report questionnaire measuring depression and anxiety
|
After 18 months
|
|
Change from baseline in the Epworth sleepiness scale, ESS
Tidsramme: After 18 moths
|
Self-report questionnaire assessing daytime sleepiness
|
After 18 moths
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Tidsramme: After 18 months
|
Self-report form assessing sleep quality
|
After 18 months
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
Tidsramme: After 18 months
|
Ultra short screening questionnaire for insomnia
|
After 18 months
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
Tidsramme: After 18 months
|
A questionnaire intended to assess acceptance of insomnia
|
After 18 months
|
|
Change from baseline in Body mass index
Tidsramme: After 18 months
|
After 18 months
|
|
|
Change from baseline in sagittal abdominal diameter
Tidsramme: After 18 months
|
Abdominal height (cm)
|
After 18 months
|
|
Change from baseline in waist-hip ratio
Tidsramme: After 18 months
|
A ratio of the circumference of the waist to the hips
|
After 18 months
|
|
Change from baseline in blood pressure
Tidsramme: After 18 months
|
After 18 months
|
|
|
Change from baseline in heart rate
Tidsramme: After 18 months
|
After 18 months
|
|
|
Change from baseline in ALAT
Tidsramme: After 18 months
|
Liver function
|
After 18 months
|
|
Change from baseline in HbA 1c
Tidsramme: After 18 months
|
Glycated hemoglobin
|
After 18 months
|
|
Change from baseline in blood glucose
Tidsramme: After 18 months
|
After 18 months
|
|
|
Change from baseline in triglycerides
Tidsramme: After 18 months
|
A type of fat found in the blood
|
After 18 months
|
|
Change from baseline in cholesterol (LDL/HDL)
Tidsramme: After 18 months
|
After 18 months
|
|
|
Change from baseline in the Insomnia severity index (ISI)
Tidsramme: After 18 months
|
A brief self-report screening form
|
After 18 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jan-Erik Broman, PhD, Uppsala University
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.
Generelle publikasjoner
- Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. doi: 10.1093/sleep/30.5.574.
- Bothelius K, Kyhle K, Espie CA, Broman JE. Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial. J Sleep Res. 2013 Dec;22(6):688-96. doi: 10.1111/jsr.12067. Epub 2013 Jul 16.
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. mai 2008
Primær fullføring (Faktiske)
1. september 2011
Studiet fullført (Faktiske)
1. september 2011
Datoer for studieregistrering
Først innsendt
4. juli 2012
Først innsendt som oppfylte QC-kriteriene
30. juli 2012
Først lagt ut (Anslag)
2. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2012
Sist bekreftet
1. juli 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RFR-10276
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .