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A Pragmatic Pilot Study of Cognitive Behavioural Therapy for Insomnia Among People Living With HIV

12 de agosto de 2019 atualizado por: Tyler Tulloch, Ryerson University
Insomnia is a problem for approximately 75% of people living with HIV, which is much higher than the 6% to 10% of people with insomnia in the general population. It is currently unknown why the rate of insomnia is so high among people living with HIV, and because of this, they are often excluded from clinical trials examining the usefulness of cognitive behavioural therapy for insomnia (CBT-I), which is recommended as the first-line treatment for insomnia. Insomnia is also associated with poorer immune functioning and lower medication adherence. The purpose of this study is to examine whether CBT-I is useful at reducing insomnia among people living with HIV, and to examine whether this counselling is safe to provide to this population. Other purposes are to explore whether reducing insomnia will lead to improved immune functioning and medication adherence, to collect feedback about people's experiences receiving CBT-I, to examine which psychological and behavioural factors are associated with insomnia severity among people living with HIV.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The prevalence of insomnia in the general population ranges from 6% to 10% (American Psychiatric Association, 2013), whereas its estimated prevalence among people living with HIV (PWH) is 73% (Rubinstein & Selwyn, 1998). Cognitive, behavioural, physiological, and psychosocial explanations for this elevated prevalence have been proposed (Taibi, 2013), however, there is a lack of consensus in the literature. Sleep disturbance is associated with disrupted immune functioning at the cellular level (Taylor, Lichstein, & Durrence, 2003), as well as increased risk of contracting infectious diseases (Patel et al., 2012); therefore, insomnia may be particularly problematic for PWH. Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is the first-line treatment for insomnia (Qaseem et al., 2016; Schutte-Rodin et al., 2008), and medium to large effect sizes have been reported (Okajima et al., 2011). CBT-I is effective at treating insomnia among individuals with comorbid medical disorders such as chronic pain (Jungquist et al., 2012), fibromyalgia (Martínez et al., 2014), and cancer (Garland et al., 2014). Surprisingly, no study to date has examined the efficacy of CBT-I among PWH. The current study will evaluate the safety, feasibility, acceptability, and effects of CBT-I among 20 PWH using a pragmatic pilot study design. An exit interview will be conducted to elicit participant feedback about the treatment and methods used. Additional cross-sectional analyses will examine predictors of insomnia symptom severity and other sleep-related outcomes among a larger sample (n = 60). This will be the first study to examine the impact of CBT-I among PWH.

Tipo de estudo

Intervencional

Inscrição (Real)

10

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

    • Ontario
      • Toronto, Ontario, Canadá, M5B 2K3
        • Department of Psychology, Ryerson 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:

  • 18 years of age or older
  • able to understand and communicate in English
  • capable of providing informed consent
  • presence of insomnia based on screener questionnaire cutoff score ≥ 15 on the Insomnia Severity Index
  • HIV-seropositive
  • willing to provide HIV viral load and CD4 count from blood work within the past two months

Exclusion Criteria:

  • active suicidal ideation
  • psychotic symptoms
  • unmanaged bipolar disorder
  • presence of a severe alcohol or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
  • hypnotic dependence
  • presence of any breathing-related sleep disorders (obstructive sleep apnea hypopnea, central sleep apnea, and sleep-related hypoventilation), or circadian rhythm sleep-wake disorders
  • working shift work or frequent time zone travel over the course of the study
  • contingent or inconsistent hypnotic use, or anticipated change in hypnotic medication dose over the course of the study
  • receiving psychotherapy for insomnia or any other mental disorder over the course of the study
  • presence of an AIDS-defining opportunistic infection and/or a CD4 count < 200

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: CBT-I
This is a single arm study in which all participants receive the intervention (cognitive behavioural therapy for insomnia)
Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is a standard 4-session cognitive behavioural therapy for insomnia administered biweekly in individual format. The first session involves presenting treatment rationale and introducing a behavioural treatment regimen consisting of a series of sleep habit parameters to follow, and determining a personalized "time in bed" prescription. The second session involves reviewing past-week sleep diary, discussing the role of cognitions in insomnia, and discussing constructive worrying techniques and the use of thought records. The third and fourth sessions are used to assist in adjusting "time in bed" prescriptions, to positively reinforce efforts, and to help problem-solve any problems they might have encountered.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Insomnia symptom severity
Prazo: Two weeks post-treatment
Insomnia symptom severity is measured using the Insomnia Severity Index (ISI)
Two weeks post-treatment

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
CD4+ (cluster of differentiation 4) cell count
Prazo: Within two months post-treatment
Obtained via self-report based on blood test results in past 3 months
Within two months post-treatment
HIV viral load
Prazo: Within two months post-treatment
Obtained via self-report based on blood test results in past 3 months
Within two months post-treatment
Combined antiretroviral therapy (cART) medication adherence
Prazo: Two weeks post-treatment
Measured using the Self-Rating Scale Item (SRSI) and Simplified Medication Adherence Questionnaire (SMAQ)
Two weeks post-treatment
Sleep efficiency
Prazo: Two weeks post-treatment
Sleep efficiency is the amount of time spent sleeping vs. awake in bed
Two weeks post-treatment
Total wake time
Prazo: Two weeks post-treatment
Total wake time is the total time spent awake between getting into bed at night
Two weeks post-treatment

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Health-related quality of life
Prazo: Two weeks post-treatment
Measured using the Medical Outcomes Study Short-Form Health Survey (SF-36)
Two weeks post-treatment
Depression symptom severity
Prazo: Two weeks post-treatment
Measured using the Centre for Epidemiological Studies in Depression Scale-Revised (CESD-R) and Depression Anxiety Stress Scales (DASS-21)
Two weeks post-treatment
Treatment acceptability
Prazo: Immediately post-treatment (final therapy session)
Measured using the Therapy Evaluation Questionnaire (TEQ)
Immediately post-treatment (final therapy session)
Intervention safety
Prazo: Two weeks post-treatment
Measured via qualitative exit interview, and includes any unwanted or adverse events associated with the intervention
Two weeks post-treatment
Dysfunctional beliefs about sleep
Prazo: Two weeks post-treatment
Measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Two weeks post-treatment
Sleep effort
Prazo: Two weeks post-treatment
Measured using the Glasgow Sleep Effort Scale (GSES)
Two weeks post-treatment
Self-efficacy for sleep
Prazo: Two weeks post-treatment
Measured using the Self-Efficacy for Sleep Scale (SE-S)
Two weeks post-treatment
Pre-sleep arousal
Prazo: Two weeks post-treatment
Measured using the Pre-Sleep Arousal Scale (PSAS-13)
Two weeks post-treatment
Fatigue
Prazo: Two weeks post treatment
Measured using the Fatigue Severity Scale (FSS)
Two weeks post treatment
Anxiety Symptom Severity
Prazo: Two weeks post treatment
Measured using the Depression Anxiety Stress Scales (DASS-21)
Two weeks post treatment
HIV-Related Fatigue
Prazo: Two weeks post treatment
Measured using the HIV-Related Fatigue Scale (HRFS)
Two weeks post treatment

Colaboradores e Investigadores

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Patrocinador

Investigadores

  • Investigador principal: Tyler Tulloch, MA, Ryerson University

Publicações e links úteis

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Publicações Gerais

Links úteis

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 setembro de 2016

Conclusão Primária (Real)

1 de novembro de 2018

Conclusão do estudo (Real)

1 de novembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

29 de agosto de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de setembro de 2016

Primeira postagem (Estimativa)

2 de setembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de agosto de 2019

Última verificação

1 de agosto de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • PSS (Número de outro subsídio/financiamento: Panaceo International Active Mineral Production GmbH)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

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