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Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

30 de julio de 2012 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

66

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Suecia
      • Uppsala, Suecia, 75105
        • Uppsala University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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.
Sin intervención: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in the Insomnia severity index (ISI)
Periodo de tiempo: After 9 weeks
A brief self-report screening form
After 9 weeks

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Uppsala University

Colaboradores

Uppsala-Örebro Regional Research Council

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2008

Finalización primaria (Actual)

1 de septiembre de 2011

Finalización del estudio (Actual)

1 de septiembre de 2011

Fechas de registro del estudio

Enviado por primera vez

4 de julio de 2012

Primero enviado que cumplió con los criterios de control de calidad

30 de julio de 2012

Publicado por primera vez (Estimar)

2 de agosto de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de agosto de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

30 de julio de 2012

Última verificación

1 de julio de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RFR-10276

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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