Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)
30 juli 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
66
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Uppsala, Sverige, 75105
- Uppsala University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Inget ingripande: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in the Insomnia severity index (ISI)
Tidsram: After 9 weeks
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A brief self-report screening form
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After 9 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in sleep-onset latency (SOL)
Tidsram: 9 weeks
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Time to fall asleep, measured with sleep diary
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9 weeks
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Change from baseline in wake time after sleep onset (WASO)
Tidsram: After 9 weeks
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Time awake during the night, measured with sleep diary
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After 9 weeks
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Change from baseline in number of awakenings during the night (NWAK)
Tidsram: After 9 weeks
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Measured with sleep diary
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After 9 weeks
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Change from baseline in Sleep efficiency (SE)
Tidsram: After 9 weeks
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Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
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After 9 weeks
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Change from baseline in time in bed (TIB)
Tidsram: After 9 weeks
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Measured with sleep diary
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After 9 weeks
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Change from baseline in total sleep time (TST)
Tidsram: After 9 weeks
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Measured with sleep diary
|
After 9 weeks
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Change from baseline in sleep quality (SQ)
Tidsram: After 9 weeks
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Subjective sleep quality (likert scale)
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After 9 weeks
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Change from baseline in the fatigue severity scale (FSS)
Tidsram: After 9 weeks
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Self-report questionnaire
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After 9 weeks
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Change from baseline in the MOS 36-item short-form health survey, SF-36
Tidsram: After 9 weeks
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Questionnaire assessing physical and mental health
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After 9 weeks
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Change from baseline in the Hospital anxiety and depression scale, HADS
Tidsram: After 9 weeks
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Self-report questionnaire measuring depression and anxiety
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After 9 weeks
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Change from baseline in the Epworth sleepiness scale, ESS
Tidsram: After 9 weeks
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Self-report questionnaire assessing daytime sleepiness
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After 9 weeks
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Change form baseline in the Pittsburgh sleep quality index (PSQI)
Tidsram: After 9 weeks
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Self-report form assessing sleep quality
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After 9 weeks
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Change from baseline in the Minimal insomnia severity scale, MISS
Tidsram: After 9 weeks
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Ultra short screening questionnaire for insomnia
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After 9 weeks
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Change from baseline in the Insomnia acceptance questionnaire, IQA
Tidsram: After 9 weeks
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A questionnaire intended to assess acceptance of insomnia
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After 9 weeks
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Change from baseline in Body mass index
Tidsram: After 9 weeks
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After 9 weeks
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Change from baseline in sagittal abdominal diameter
Tidsram: After 9 weeks
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Abdominal height (cm)
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After 9 weeks
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Change from baseline in waist-hip ratio
Tidsram: After 9 weeks
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A ratio of the circumference of the waist to the hips
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After 9 weeks
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Change from baseline in blood pressure
Tidsram: After 9 weeks
|
After 9 weeks
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Change from baseline in heart rate
Tidsram: After 9 weeks
|
After 9 weeks
|
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Change from baseline in ALAT
Tidsram: After 9 weeks
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Liver function
|
After 9 weeks
|
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Change from baseline in HbA 1c
Tidsram: After 9 weeks
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Glycated hemoglobin
|
After 9 weeks
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Change from baseline in blood glucose
Tidsram: After 9 weeks
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After 9 weeks
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Change from baseline in triglycerides
Tidsram: After 9 weeks
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A type of fat found in the blood
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After 9 weeks
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Change from baseline in cholesterol (LDL/HDL)
Tidsram: After 9 weeks
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After 9 weeks
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Change from baseline in sleep-onset latency (SOL)
Tidsram: After 18 months
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Time to fall asleep, measured with sleep diary
|
After 18 months
|
|
Change from baseline in wake time after sleep onset (WASO)
Tidsram: 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)
Tidsram: After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in Sleep efficiency (SE)
Tidsram: 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)
Tidsram: After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in total sleep time (TST)
Tidsram: After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in sleep quality (SQ)
Tidsram: After 18 months
|
Subjective sleep quality (likert scale)
|
After 18 months
|
|
Change from baseline in the fatigue severity scale (FSS)
Tidsram: After 18 months
|
Self-report questionnaire
|
After 18 months
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
Tidsram: After 18 months
|
Questionnaire assessing physical and mental health
|
After 18 months
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
Tidsram: After 18 months
|
Self-report questionnaire measuring depression and anxiety
|
After 18 months
|
|
Change from baseline in the Epworth sleepiness scale, ESS
Tidsram: After 18 moths
|
Self-report questionnaire assessing daytime sleepiness
|
After 18 moths
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Tidsram: After 18 months
|
Self-report form assessing sleep quality
|
After 18 months
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
Tidsram: After 18 months
|
Ultra short screening questionnaire for insomnia
|
After 18 months
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
Tidsram: After 18 months
|
A questionnaire intended to assess acceptance of insomnia
|
After 18 months
|
|
Change from baseline in Body mass index
Tidsram: After 18 months
|
After 18 months
|
|
|
Change from baseline in sagittal abdominal diameter
Tidsram: After 18 months
|
Abdominal height (cm)
|
After 18 months
|
|
Change from baseline in waist-hip ratio
Tidsram: After 18 months
|
A ratio of the circumference of the waist to the hips
|
After 18 months
|
|
Change from baseline in blood pressure
Tidsram: After 18 months
|
After 18 months
|
|
|
Change from baseline in heart rate
Tidsram: After 18 months
|
After 18 months
|
|
|
Change from baseline in ALAT
Tidsram: After 18 months
|
Liver function
|
After 18 months
|
|
Change from baseline in HbA 1c
Tidsram: After 18 months
|
Glycated hemoglobin
|
After 18 months
|
|
Change from baseline in blood glucose
Tidsram: After 18 months
|
After 18 months
|
|
|
Change from baseline in triglycerides
Tidsram: After 18 months
|
A type of fat found in the blood
|
After 18 months
|
|
Change from baseline in cholesterol (LDL/HDL)
Tidsram: After 18 months
|
After 18 months
|
|
|
Change from baseline in the Insomnia severity index (ISI)
Tidsram: After 18 months
|
A brief self-report screening form
|
After 18 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jan-Erik Broman, PhD, Uppsala University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2008
Primärt slutförande (Faktisk)
1 september 2011
Avslutad studie (Faktisk)
1 september 2011
Studieregistreringsdatum
Först inskickad
4 juli 2012
Först inskickad som uppfyllde QC-kriterierna
30 juli 2012
Första postat (Uppskatta)
2 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 augusti 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juli 2012
Senast verifierad
1 juli 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RFR-10276
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .