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Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

30 de julho de 2012 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

66

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Suécia
      • Uppsala, Suécia, 75105
        • Uppsala University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.
Sem intervenção: Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in the Insomnia severity index (ISI)
Prazo: After 9 weeks
A brief self-report screening form
After 9 weeks

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Uppsala University

Colaboradores

Uppsala-Örebro Regional Research Council

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2008

Conclusão Primária (Real)

1 de setembro de 2011

Conclusão do estudo (Real)

1 de setembro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

4 de julho de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de julho de 2012

Primeira postagem (Estimativa)

2 de agosto de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

2 de agosto de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2012

Última verificação

1 de julho de 2012

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RFR-10276

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