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Treatment of Insomnia and Depression in Elders (TIDE) (TIDE)

30 de novembro de 2015 atualizado por: University of Alabama, Tuscaloosa

Insomnia and depression are two of the most prevalent mental health disorders and often co-occur.

Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources.

The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Antecipado)

46

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

    • Alabama
      • Tuscaloosa, Alabama, Estados Unidos, 35487
        • UATuscaloosa

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

50 anos a 100 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 50 years of age or older,
  • resident of the Black Belt or adjacent counties and receiving services from one of our primary care collaborators
  • absence of significant cognitive impairment as indicated by a score of 24 or higher (17 or higher for those with only an eighth grade education) on the Mini-Mental Status Examination (MMSE; Folstein, Folstein, & McHugh, 1975
  • not currently receiving psychological treatment,
  • absence of serious suicidality
  • concurrent psychiatric/medical disorders are not automatic disqualifiers unless they prevent participants from attending CBT therapy sessions or impede data collection,
  • a referral from their primary care physician indicating presence of both insomnia and depression symptoms of sufficient significance to warrant initiation or continuance of primary care treatment for newly emergent or residual symptoms. Persons who are currently receiving pharmacotherapy for insomnia and/or depression must evidence residual symptoms of both disorders of sufficient magnitude to be evaluated as clinically significant and warranting further treatment by their primary care physician.

Exclusion Criteria:

  • age is below 50
  • not receiving services from one of our primary care collaborators
  • significant cognitive impairment is present as indicated by a score of 23 or lower (16 or lower for those with only an eighth grade education) on the MMSE
  • currently receiving psychological treatment
  • presence of serious suicidality
  • intrusive and unstable concurrent psychiatric/medical disorders
  • primary care physician declines to refer

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: CBT
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
Comparador Ativo: Treatment as Usual
No additional treatment besides regular care.
Standard Care - Treatment as usual

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Insomnia Severity Index
Prazo: 3-month follow-up (23weeks post-treatment)
Insomnia Measure
3-month follow-up (23weeks post-treatment)
Hamilton Depression Scale
Prazo: 10 weeks Post-treatment
Depression measure
10 weeks Post-treatment
Hamilton Depression Scale
Prazo: 3 Month follow-up (23 weeks post treatment)
Depression Measure
3 Month follow-up (23 weeks post treatment)
Insomnia Severity Index
Prazo: 10 weeks Post-treatment
Insomnia Measure
10 weeks Post-treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
GDS
Prazo: Pre-Treatment (Baseline/Week 0)
Self-reported Geriatric Depression Scale
Pre-Treatment (Baseline/Week 0)
SOL
Prazo: Pre-Treatment (Baseline/Week 0)
self-reported Sleep Onset Latency
Pre-Treatment (Baseline/Week 0)
WASO
Prazo: Pre-Treatment (Baseline/Week 0)
Wake-time After Sleep Onset
Pre-Treatment (Baseline/Week 0)
SOL
Prazo: 10 weeks Post-treatment
Self-reported Sleep onset latency
10 weeks Post-treatment
SOL
Prazo: 3-month follow-up (23weeks post-treatment)
Self-reported Sleep onset latency
3-month follow-up (23weeks post-treatment)
GDS
Prazo: 10 weeks Post-treatment
Self Reported Geriatric Depression Scale
10 weeks Post-treatment
GDS
Prazo: 3-month follow-up (23weeks post-treatment)
Self-reported Geriatric Depression Scale
3-month follow-up (23weeks post-treatment)
WASO
Prazo: 10 weeks Post-treatment
Wake-time After Sleep Onset
10 weeks Post-treatment
WASO
Prazo: 3-month follow-up (23weeks post-treatment)
Wake-time After Sleep Onset
3-month follow-up (23weeks post-treatment)

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Kenneth L. Lichstein, Ph.D., University of Alabama, Tuscaloosa
  • Investigador principal: Forrest Scogin, Ph.D., University of Alabama, Tuscaloosa

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 junho de 2012

Conclusão Primária (Real)

1 de março de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de julho de 2012

Primeira postagem (Estimativa)

24 de julho de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

2 de dezembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de novembro de 2015

Última verificação

1 de novembro de 2015

Mais Informações

Termos relacionados a este estudo

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