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Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders

5 de agosto de 2020 atualizado por: University of California, San Francisco

Interventions for Symptom Management in Older Patients With HAND

The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction (MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and have maximized treatment options.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

This study addresses symptom management for patients aged 60 and older who are living with HIV infection, are on combination antiretroviral therapy (cART) with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HIV-associated neurocognitive disorders (HAND). It is increasingly relevant that HAND persists despite cART, impacting between 30-50% of elders living with HIV. Patients suffer symptoms that are pervasive in their impact on everyday functioning and quality of life; yet these patients are currently left with a dearth of treatment options. In this study, the investigators employ a randomized controlled evaluation of Mindfulness Based Stress Reduction (MBSR) to target attention, stress, anxiety, and depressive symptoms among patients who have HAND and have maximized treatment options. The investigators will employ intrinsic connectivity network (ICN) analyses of resting state functional magnetic resonance imaging to demonstrate increased strength of brain networks corresponding to improved symptoms. The investigators will quantify social networks and perceived strength of social networks to determine if they moderate the main findings. Together this work employs geriatric, neuroscience and complementary medicine disciplines to reduce the symptom burden in aging HIV-infected patients.

Tipo de estudo

Intervencional

Inscrição (Real)

180

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

    • California
      • San Francisco, California, Estados Unidos, 94158
        • UCSF Memory and Aging Center

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age ≥ 55 years
  • HIV-infected. For cases in which a participant has an undetectable plasma viral load and is not currently on cART, the participant will be asked to complete HIV antibody testing.
  • Undetectable plasma viral load
  • Symptomatic and sufficient neuropsychological testing abnormality to be rated as having impairment by consensus conference, but deficits in everyday functioning that would rate them as having no more than moderate disease. Participants with severe deficits consistent with dementia will not be randomized unless the study team agrees that deficits are mild enough to withstand rigors of MBSR.

Exclusion Criteria:

  • Age < 55 years
  • Failure to attend screening visits after two attempts and despite support offered
  • Unwilling to participate in 8-week intervention
  • Endorsing illicit drug use in the past 6 months
  • Current or extensive previous mindfulness practitioner
  • Detectable plasma HIV RNA (VL) in the previous 6 months or at enrollment. Individuals with VL <500 copies will be allowed to enroll if they have a history of UD VL with unchanged cART and show documentation of their past two clinical VL at UD levels (so called "viral blips").
  • Any treatable condition that may impact cognition, including:

    • Neurosyphilis (cases with serum RPR positive will undergo lumbar puncture to evaluate)
    • Thyroid disorders (untreated)
    • B12 deficiency (untreated)
    • Cancer (requiring chemotherapy)
    • Neurological or psychiatric conditions where treatment options exist, such as multiple sclerosis, schizophrenia, uncontrolled epilepsy, recent and untreated major depression
    • HIV CNS escape (lumbar punctures will be completed in cases with clinical scenarios worrisome for escape as done clinically; e.g. more rapid course, new neurological symptoms, recent resistance in plasma)
  • Language other than English as the main language of oral and written communication
  • Inability to provide informed consent or assent with a legal surrogate to sign consent
  • Major recent head injury, stroke, or major confounding cognitive factors including:

    • Cognitive impairment caused primarily by alcohol or substance use
    • Current active use of methamphetamine, cocaine or illicit use of narcotics (determined at screening and enrollment visits via clinical interview of substance abuse and dependence criteria)
    • MRI demonstrating current or past CNS lesions deemed to be clinically significant including that from past opportunistic infections but excluding white matter injury, as can be seen with cerebrovascular disease
    • Active brain infection, except for HIV
    • Significant systemic medical illness such as cancer requiring chemotherapy or end-stage cardiac or renal insufficiency
  • Unstable psychiatric condition (e.g. active psychosis, suicidal ideation, homicidal ideation) or mental health or medical condition that, in the opinion of the investigators, will make it difficult for the potential participant to participate in the intervention
  • Cases where the investigators feel the participant won't be able to complete 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: MBSR
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
Experimental: CONTROL
Participants in the waitlist control arm will receive standard of care for 16 weeks after the baseline visit, and then will be offered an identical 8-week MBSR course.
Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Continuous Performance Task
Prazo: 48 weeks after enrollment
A neuropsychological test to assess attention and information processing and executive functioning
48 weeks after enrollment
Symbol-Digit modalities test
Prazo: 48 weeks after enrollment
A neuropsychological test to assess executive functioning
48 weeks after enrollment
Letter Number Sequencing
Prazo: 48 weeks after enrollment
A neuropsychological test to assess executive functioning
48 weeks after enrollment
Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
Prazo: 48 weeks after enrollment
Questionnaires to assess everyday function
48 weeks after enrollment
Perceived Stress Scale
Prazo: 48 weeks after enrollment
Questionnaire to assess stress
48 weeks after enrollment
State-Trait Anxiety Inventory
Prazo: 48 weeks after enrollment
Questionnaire to assess anxiety
48 weeks after enrollment
Geriatric Depression Scale
Prazo: 48 weeks after enrollment
Questionnaire to assess depression
48 weeks after enrollment
Buss-Durkee Irritability subscale
Prazo: 48 weeks after enrollment
Questionnaire to assess irritability
48 weeks after enrollment
Center for Neurological Study - Lability Scale
Prazo: 48 weeks after enrollment
Questionnaire to assess affective lability
48 weeks after enrollment
Affective Intensity Measure
Prazo: 48 weeks after enrollment
Questionnaire to assess euphoria
48 weeks after enrollment
World Health Organization Quality of Life - HIV Scale
Prazo: 48 weeks after enrollment
Questionnaire to assess quality of life
48 weeks after enrollment
Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging
Prazo: 16 weeks after enrollment
16 weeks after enrollment
Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
Prazo: 16 weeks after enrollment
16 weeks after enrollment

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Victor Valcour, MD PhD, University of California, San Francisco
  • Investigador principal: Judith Moskowitz, PhD MPH, Northwestern University

Publicações e links úteis

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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)

30 de março de 2015

Conclusão Primária (Real)

7 de novembro de 2019

Conclusão do estudo (Real)

7 de novembro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

27 de julho de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de outubro de 2016

Primeira postagem (Estimativa)

18 de outubro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de agosto de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de agosto de 2020

Última verificação

1 de agosto de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 5R01NR015223 (Concessão/Contrato do NIH dos EUA)
  • R01NR015223 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

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 .

Ensaios clínicos em Infecção pelo HIV

Ensaios clínicos em MBSR

3
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