- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02936401
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
Condições
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
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California
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San Francisco, California, Estados Unidos, 94158
- UCSF Memory and Aging Center
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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 |
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Experimental: MBSR
Participants in this arm enter the 8-week MBSR course immediately after the baseline visit.
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Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
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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.
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Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Continuous Performance Task
Prazo: 48 weeks after enrollment
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A neuropsychological test to assess attention and information processing and executive functioning
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48 weeks after enrollment
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Symbol-Digit modalities test
Prazo: 48 weeks after enrollment
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A neuropsychological test to assess executive functioning
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48 weeks after enrollment
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Letter Number Sequencing
Prazo: 48 weeks after enrollment
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A neuropsychological test to assess executive functioning
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48 weeks after enrollment
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Activities of Daily Living (ADL) & Instrumental Activities of Daily Living (IADL) scales
Prazo: 48 weeks after enrollment
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Questionnaires to assess everyday function
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48 weeks after enrollment
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Perceived Stress Scale
Prazo: 48 weeks after enrollment
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Questionnaire to assess stress
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48 weeks after enrollment
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State-Trait Anxiety Inventory
Prazo: 48 weeks after enrollment
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Questionnaire to assess anxiety
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48 weeks after enrollment
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Geriatric Depression Scale
Prazo: 48 weeks after enrollment
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Questionnaire to assess depression
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48 weeks after enrollment
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Buss-Durkee Irritability subscale
Prazo: 48 weeks after enrollment
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Questionnaire to assess irritability
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48 weeks after enrollment
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Center for Neurological Study - Lability Scale
Prazo: 48 weeks after enrollment
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Questionnaire to assess affective lability
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48 weeks after enrollment
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Affective Intensity Measure
Prazo: 48 weeks after enrollment
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Questionnaire to assess euphoria
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48 weeks after enrollment
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World Health Organization Quality of Life - HIV Scale
Prazo: 48 weeks after enrollment
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Questionnaire to assess quality of life
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48 weeks after enrollment
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Connectivity of the default mode network (DMN) as determined by analysis of resting state functional magnetic resonance imaging
Prazo: 16 weeks after enrollment
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16 weeks after enrollment
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Connectivity of the salience network (SAL) as determined by analysis of resting state functional magnetic resonance imaging
Prazo: 16 weeks after enrollment
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16 weeks after enrollment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Victor Valcour, MD PhD, University of California, San Francisco
- Investigador principal: Judith Moskowitz, PhD MPH, Northwestern 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
- Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008 Feb;31(1):23-33. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.
- Sacktor N, McDermott MP, Marder K, Schifitto G, Selnes OA, McArthur JC, Stern Y, Albert S, Palumbo D, Kieburtz K, De Marcaida JA, Cohen B, Epstein L. HIV-associated cognitive impairment before and after the advent of combination therapy. J Neurovirol. 2002 Apr;8(2):136-42. doi: 10.1080/13550280290049615.
- Lau MA, Bishop SR, Segal ZV, Buis T, Anderson ND, Carlson L, Shapiro S, Carmody J, Abbey S, Devins G. The Toronto Mindfulness Scale: development and validation. J Clin Psychol. 2006 Dec;62(12):1445-67. doi: 10.1002/jclp.20326.
- Cohen-Katz J, Wiley SD, Capuano T, Baker DM, Kimmel S, Shapiro S. The effects of mindfulness-based stress reduction on nurse stress and burnout, Part II: A quantitative and qualitative study. Holist Nurs Pract. 2005 Jan-Feb;19(1):26-35. doi: 10.1097/00004650-200501000-00008. Erratum In: Holist Nurs Pract. 2005 Mar-Apr;19(2):78. Kimmel, Sharon [added].
- Jain S, Shapiro SL, Swanick S, Roesch SC, Mills PJ, Bell I, Schwartz GE. A randomized controlled trial of mindfulness meditation versus relaxation training: effects on distress, positive states of mind, rumination, and distraction. Ann Behav Med. 2007 Feb;33(1):11-21. doi: 10.1207/s15324796abm3301_2.
- Gayner B, Esplen MJ, DeRoche P, Wong J, Bishop S, Kavanagh L, Butler K. A randomized controlled trial of mindfulness-based stress reduction to manage affective symptoms and improve quality of life in gay men living with HIV. J Behav Med. 2012 Jun;35(3):272-85. doi: 10.1007/s10865-011-9350-8. Epub 2011 May 20.
- Cysique LA, Brew BJ. Neuropsychological functioning and antiretroviral treatment in HIV/AIDS: a review. Neuropsychol Rev. 2009 Jun;19(2):169-85. doi: 10.1007/s11065-009-9092-3. Epub 2009 May 9.
- Cysique LA, Maruff P, Brew BJ. Variable benefit in neuropsychological function in HIV-infected HAART-treated patients. Neurology. 2006 May 9;66(9):1447-50. doi: 10.1212/01.wnl.0000210477.63851.d3.
- Robertson KR, Smurzynski M, Parsons TD, Wu K, Bosch RJ, Wu J, McArthur JC, Collier AC, Evans SR, Ellis RJ. The prevalence and incidence of neurocognitive impairment in the HAART era. AIDS. 2007 Sep 12;21(14):1915-21. doi: 10.1097/QAD.0b013e32828e4e27.
- Valcour V, Shikuma C, Shiramizu B, Watters M, Poff P, Selnes O, Holck P, Grove J, Sacktor N. Higher frequency of dementia in older HIV-1 individuals: the Hawaii Aging with HIV-1 Cohort. Neurology. 2004 Sep 14;63(5):822-7. doi: 10.1212/01.wnl.0000134665.58343.8d.
- Kanmogne GD, Kuate CT, Cysique LA, Fonsah JY, Eta S, Doh R, Njamnshi DM, Nchindap E, Franklin DR Jr, Ellis RJ, McCutchan JA, Binam F, Mbanya D, Heaton RK, Njamnshi AK. HIV-associated neurocognitive disorders in sub-Saharan Africa: a pilot study in Cameroon. BMC Neurol. 2010 Jul 13;10:60. doi: 10.1186/1471-2377-10-60.
- Tozzi V, Balestra P, Bellagamba R, Corpolongo A, Salvatori MF, Visco-Comandini U, Vlassi C, Giulianelli M, Galgani S, Antinori A, Narciso P. Persistence of neuropsychologic deficits despite long-term highly active antiretroviral therapy in patients with HIV-related neurocognitive impairment: prevalence and risk factors. J Acquir Immune Defic Syndr. 2007 Jun 1;45(2):174-82. doi: 10.1097/QAI.0b013e318042e1ee.
- Vance DE, Fazeli PL, Grant JS, Slater LZ, Raper JL. The role of neuroplasticity and cognitive reserve in aging with HIV: recommendations for cognitive protection and rehabilitation. J Neurosci Nurs. 2013 Oct;45(5):306-16. doi: 10.1097/JNN.0b013e31829d8b29.
- Cohen-Katz J, Wiley S, Capuano T, Baker DM, Deitrick L, Shapiro S. The effects of mindfulness-based stress reduction on nurse stress and burnout: a qualitative and quantitative study, part III. Holist Nurs Pract. 2005 Mar-Apr;19(2):78-86. doi: 10.1097/00004650-200503000-00009.
- Moynihan JA, Chapman BP, Klorman R, Krasner MS, Duberstein PR, Brown KW, Talbot NL. Mindfulness-based stress reduction for older adults: effects on executive function, frontal alpha asymmetry and immune function. Neuropsychobiology. 2013;68(1):34-43. doi: 10.1159/000350949. Epub 2013 Jun 15.
- Shapiro SL, Oman D, Thoresen CE, Plante TG, Flinders T. Cultivating mindfulness: effects on well-being. J Clin Psychol. 2008 Jul;64(7):840-62. doi: 10.1002/jclp.20491.
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
Termos MeSH relevantes adicionais
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 .
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