Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Brief Behavioral Insomnia Treatment Study (BBTI)

28 de janeiro de 2020 atualizado por: VA Office of Research and Development

Telephone-Facilitated Insomnia Treatment in Primary Care for OEF/OIF/OND Veterans

The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and overall health among Veterans with insomnia disorder.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This study is a randomized, controlled trial of a telephone-based, brief insomnia treatment in primary care in order to accomplish the goal of improving psychosocial functioning in Veterans who meet criteria for Insomnia Disorder. The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include evaluating durability of treatment gains and obtaining feedback from participants about the utility and feasibility of the proposed insomnia treatment.

Tipo de estudo

Intervencional

Inscrição (Real)

93

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

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94121
        • San Francisco VA Medical Center, San Francisco, CA

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 a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Veterans between the ages of 18-75 years.
  • Meet DSM-5 Criteria for Insomnia Disorder.
  • Able attend in-person appointments at the San Francisco VA Medical Center

  • The investigators will not exclude individuals who are taking insomnia or antidepressant medications, provided they have been stable on these medications for at least one month and still meet criteria for Insomnia Disorder as described above.

    • Specifically, individuals receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will not be excluded provided they meet the criteria described above.

  • The investigators will not exclude Veterans receiving any type of psychotherapy, provided they have received this treatment for at least three months and do not plan to discontinue this treatment during the BBTI trial.

    • However, individual who need to start a new type of psychotherapy during the course of the treatment will be excluded, or they will need to wait three months in order to enroll in the trial.
  • The investigators will not exclude individuals with TBI.
  • The investigators will not exclude individuals with chronic pain.
  • The investigators will not exclude individuals based on any other mental health condition, including posttraumatic stress disorder and depression.

Exclusion Criteria:

  • Conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, and alcohol or drug dependence within the past year.
  • Individuals who meet criteria for alcohol or drug abuse will be asked to reduce alcohol to recommended limits during the course of the study and/or refrain from drug use in order to be included.
  • Veterans with suicidal or homicidal ideation.
  • Veterans who are pregnant, due to the biological impact of pregnancy on sleep.
  • Veterans who work night or rotating shifts.
  • Veterans with untreated moderate to severe sleep apnea (those receiving treatment will not be excluded from the study).

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 Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Comportamental: Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Comparador Ativo: Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Comportamental: Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Work and Social Adjustment Scale (WSAS)
Prazo: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Work and Social Adjustment Scale (WSAS)
Prazo: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Insomnia Severity (ISI)
Prazo: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Insomnia Severity (ISI)
Prazo: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only
Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only

Colaboradores e Investigadores

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

Patrocinador

VA Office of Research and Development

Colaboradores

University of California, San Francisco

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 (Real)

6 de janeiro de 2016

Conclusão Primária (Real)

31 de março de 2019

Conclusão do estudo (Real)

30 de junho de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

2 de outubro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de outubro de 2015

Primeira postagem (Estimativa)

8 de outubro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de fevereiro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de janeiro de 2020

Última verificação

1 de janeiro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D1539-I

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever