Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

30 juillet 2012 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

66

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Suède
      • Uppsala, Suède, 75105
        • Uppsala University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Aucune intervention: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in the Insomnia severity index (ISI)
Délai: After 9 weeks
A brief self-report screening form
After 9 weeks

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Uppsala University

Collaborateurs

Uppsala-Örebro Regional Research Council

Les enquêteurs

  • Chercheur principal: Jan-Erik Broman, PhD, Uppsala University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2008

Achèvement primaire (Réel)

1 septembre 2011

Achèvement de l'étude (Réel)

1 septembre 2011

Dates d'inscription aux études

Première soumission

4 juillet 2012

Première soumission répondant aux critères de contrôle qualité

30 juillet 2012

Première publication (Estimation)

2 août 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 août 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juillet 2012

Dernière vérification

1 juillet 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RFR-10276

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Cognitive behavior therapy for insomnia

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Belarus

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner