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Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

30. Juli 2012 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

66

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweden
      • Uppsala, Schweden, 75105
        • Uppsala University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Cognitive behavior therapy for insomnia
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.
Kein Eingriff: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in the Insomnia severity index (ISI)
Zeitfenster: After 9 weeks
A brief self-report screening form
After 9 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in sleep-onset latency (SOL)
Zeitfenster: 9 weeks
Time to fall asleep, measured with sleep diary
9 weeks
Change from baseline in wake time after sleep onset (WASO)
Zeitfenster: 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)
Zeitfenster: After 9 weeks
Measured with sleep diary
After 9 weeks
Change from baseline in Sleep efficiency (SE)
Zeitfenster: 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)
Zeitfenster: After 9 weeks
Measured with sleep diary
After 9 weeks
Change from baseline in total sleep time (TST)
Zeitfenster: After 9 weeks
Measured with sleep diary
After 9 weeks
Change from baseline in sleep quality (SQ)
Zeitfenster: After 9 weeks
Subjective sleep quality (likert scale)
After 9 weeks
Change from baseline in the fatigue severity scale (FSS)
Zeitfenster: After 9 weeks
Self-report questionnaire
After 9 weeks
Change from baseline in the MOS 36-item short-form health survey, SF-36
Zeitfenster: After 9 weeks
Questionnaire assessing physical and mental health
After 9 weeks
Change from baseline in the Hospital anxiety and depression scale, HADS
Zeitfenster: After 9 weeks
Self-report questionnaire measuring depression and anxiety
After 9 weeks
Change from baseline in the Epworth sleepiness scale, ESS
Zeitfenster: After 9 weeks
Self-report questionnaire assessing daytime sleepiness
After 9 weeks
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Zeitfenster: After 9 weeks
Self-report form assessing sleep quality
After 9 weeks
Change from baseline in the Minimal insomnia severity scale, MISS
Zeitfenster: After 9 weeks
Ultra short screening questionnaire for insomnia
After 9 weeks
Change from baseline in the Insomnia acceptance questionnaire, IQA
Zeitfenster: After 9 weeks
A questionnaire intended to assess acceptance of insomnia
After 9 weeks
Change from baseline in Body mass index
Zeitfenster: After 9 weeks
After 9 weeks
Change from baseline in sagittal abdominal diameter
Zeitfenster: After 9 weeks
Abdominal height (cm)
After 9 weeks
Change from baseline in waist-hip ratio
Zeitfenster: After 9 weeks
A ratio of the circumference of the waist to the hips
After 9 weeks
Change from baseline in blood pressure
Zeitfenster: After 9 weeks
After 9 weeks
Change from baseline in heart rate
Zeitfenster: After 9 weeks
After 9 weeks
Change from baseline in ALAT
Zeitfenster: After 9 weeks
Liver function
After 9 weeks
Change from baseline in HbA 1c
Zeitfenster: After 9 weeks
Glycated hemoglobin
After 9 weeks
Change from baseline in blood glucose
Zeitfenster: After 9 weeks
After 9 weeks
Change from baseline in triglycerides
Zeitfenster: After 9 weeks
A type of fat found in the blood
After 9 weeks
Change from baseline in cholesterol (LDL/HDL)
Zeitfenster: After 9 weeks
After 9 weeks
Change from baseline in sleep-onset latency (SOL)
Zeitfenster: After 18 months
Time to fall asleep, measured with sleep diary
After 18 months
Change from baseline in wake time after sleep onset (WASO)
Zeitfenster: 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)
Zeitfenster: After 18 months
Measured with sleep diary
After 18 months
Change from baseline in Sleep efficiency (SE)
Zeitfenster: 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)
Zeitfenster: After 18 months
Measured with sleep diary
After 18 months
Change from baseline in total sleep time (TST)
Zeitfenster: After 18 months
Measured with sleep diary
After 18 months
Change from baseline in sleep quality (SQ)
Zeitfenster: After 18 months
Subjective sleep quality (likert scale)
After 18 months
Change from baseline in the fatigue severity scale (FSS)
Zeitfenster: After 18 months
Self-report questionnaire
After 18 months
Change from baseline in the MOS 36-item short-form health survey, SF-36
Zeitfenster: After 18 months
Questionnaire assessing physical and mental health
After 18 months
Change from baseline in the Hospital anxiety and depression scale, HADS
Zeitfenster: After 18 months
Self-report questionnaire measuring depression and anxiety
After 18 months
Change from baseline in the Epworth sleepiness scale, ESS
Zeitfenster: After 18 moths
Self-report questionnaire assessing daytime sleepiness
After 18 moths
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Zeitfenster: After 18 months
Self-report form assessing sleep quality
After 18 months
Change from baseline in the Minimal insomnia severity scale, MISS
Zeitfenster: After 18 months
Ultra short screening questionnaire for insomnia
After 18 months
Change from baseline in the Insomnia acceptance questionnaire, IQA
Zeitfenster: After 18 months
A questionnaire intended to assess acceptance of insomnia
After 18 months
Change from baseline in Body mass index
Zeitfenster: After 18 months
After 18 months
Change from baseline in sagittal abdominal diameter
Zeitfenster: After 18 months
Abdominal height (cm)
After 18 months
Change from baseline in waist-hip ratio
Zeitfenster: After 18 months
A ratio of the circumference of the waist to the hips
After 18 months
Change from baseline in blood pressure
Zeitfenster: After 18 months
After 18 months
Change from baseline in heart rate
Zeitfenster: After 18 months
After 18 months
Change from baseline in ALAT
Zeitfenster: After 18 months
Liver function
After 18 months
Change from baseline in HbA 1c
Zeitfenster: After 18 months
Glycated hemoglobin
After 18 months
Change from baseline in blood glucose
Zeitfenster: After 18 months
After 18 months
Change from baseline in triglycerides
Zeitfenster: After 18 months
A type of fat found in the blood
After 18 months
Change from baseline in cholesterol (LDL/HDL)
Zeitfenster: After 18 months
After 18 months
Change from baseline in the Insomnia severity index (ISI)
Zeitfenster: After 18 months
A brief self-report screening form
After 18 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Uppsala University

Mitarbeiter

Uppsala-Örebro Regional Research Council

Ermittler

  • Hauptermittler: Jan-Erik Broman, PhD, Uppsala University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2008

Primärer Abschluss (Tatsächlich)

1. September 2011

Studienabschluss (Tatsächlich)

1. September 2011

Studienanmeldedaten

Zuerst eingereicht

4. Juli 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juli 2012

Zuerst gepostet (Schätzen)

2. August 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

2. August 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juli 2012

Zuletzt verifiziert

1. Juli 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RFR-10276

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