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- Ensaio Clínico NCT02909101
Project IMPACT: Improving Memory Performance by Applying Cognitive Training
25 de outubro de 2019 atualizado por: Duke University
Cognitive Training to Reduce Impulsivity in HIV-infected Cocaine Users
The purpose of this study is to examine the effects of a cognitive training program in persons with Human Immunodeficiency Virus (HIV) infection who have used cocaine.
This study tests the feasibility and preliminary efficacy of a computerized cognitive training program to improve working memory and decrease impulsivity (delay discounting) among HIV-infected individuals.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Of the 1.2 million Americans living with HIV, over half experience neurocognitive impairments (NCI) that adversely affect daily living and are predictive of increased morbidity and mortality.
HIV-infected individuals who are addicted to stimulant drugs like cocaine are at even higher risk for NCI, which contributes to impulsive decision making, and engage in high rates of risky behaviors that are associated with both poor clinical outcomes and HIV transmission to others.
Delay discounting, a key aspect of impulsivity, describes the tendency to devalue a reward as the delay to its receipt increases.
Individuals addicted to drugs tend to prefer smaller, immediate rewards over larger, delayed rewards.
Excessive discounting is associated with a wide range of other health risk behaviors, including risky sex.
The Competing Neurobehavioral Decision Systems model posits that excessive discounting results from greater relative strength of the impulsive system over the executive control system.
The investigators' own work suggests that HIV infection modulates the effect of cocaine on brain functioning in the executive control network during delay discounting.
Prior research supports a robust association between excessive discounting and working memory impairment.
As a core executive function that supports self-regulation, working memory is theoretically an intervention target for HIV risk reduction.
Computerized working memory training has been shown to decrease delay discounting in stimulant users, but it has not yet been tested in HIV-infected drug users.
The proposed R21 study will test the preliminary efficacy of a computerized cognitive training program to improve working memory and reduce delay discounting in HIV-infected cocaine users.
Using a randomized trial design, the investigators will assign 50 participants to either the experimental cognitive training condition or an attention-matched control condition.
Participants will complete 48 sessions in 8 weeks, with assessments at baseline, post-training, and 1-month follow-up to evaluate intervention effects.
The investigators hypothesize that cognitive training will, relative to the control condition, lead to greater improvements in working memory and reductions in delay discounting.
The investigators will also examine change in HIV risk behaviors (cocaine use, risky sex, and medication adherence).
Results will support an R01 application for a larger scale trial to rigorously test the impact of cognitive training on HIV-related behavioral and clinical outcomes.
This innovative line of research has important translational implications for HIV clinical practice, including dissemination in resource-limited settings with few neuropsychology specialists.
This proposal directly advances a high priority topic for AIDS-designated funding by testing a novel treatment for HIV-associated NCI in drug users.
By focusing on a high-risk population that continues to drive HIV transmission, this research has strong potential to improve neurobehavioral functioning in HIV-infected persons, and ultimately to reduce the incidence of new HIV infections.
Tipo de estudo
Intervencional
Inscrição (Real)
58
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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North Carolina
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Durham, North Carolina, Estados Unidos, 27708
- Duke University Medical 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
18 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- HIV infection
- currently on antiretroviral medications for >3 months
- cocaine use as defined by crack/cocaine use in the past month, cocaine-type stimulant use disorder, and cocaine as the principal substance of abuse
- working memory impairment as defined by scoring >1 standard deviation below the normative mean on at least 2 out of the 3 working memory tests
Exclusion Criteria:
- pregnancy
- English non-fluency or illiteracy
- <8th grade education
- serious neurological disorders including HIV dementia, traumatic brain injury, severe mental illness, or acute psychiatric distress
- impaired mental status
- individuals who state they are planning to move away from the area within the next 3 months
- individuals without stable housing
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Active Cognitive Training (ACT)
Participants will complete computerized games designed to enhance working memory.
Participants will complete 48 training sessions over 8 weeks.
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Cognitive training games
Outros nomes:
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Comparador Falso: Control Training (CON)
Participants will complete 48 training sessions over 8 weeks.
The control games are not designed to enhance memory.
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Cognitive training games
Outros nomes:
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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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Working Memory Assessed by Domain Deficit Score
Prazo: Baseline; post-training, approximately 8 weeks
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Measured by domain deficit score, which is a continuous measure of overall impairment on the domain.
0 means no impairment and 5 means highest possible impairment.
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Baseline; post-training, approximately 8 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)
Prazo: Baseline; post-training, approximately 8 weeks
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The Monetary Choice Questionnaire (MCQ) is a standardized delay discounting task.
Because scores are on a logarithmic scale, they were rank ordered for analysis.
Ranks range from 1 to 13, with higher ranks meaning higher impulsivity.
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Baseline; post-training, approximately 8 weeks
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Acceptability as Measured by Participant Ratings
Prazo: Post-training, approximately 8 weeks
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Participants rated how satisfied they found the intervention on a 5 point scale (with 1 being very dissatisfied and 5 being very satisfied).
Acceptability was defined a priori of achieving a mean rating of >3.5 on the 5 point scale.
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Post-training, approximately 8 weeks
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Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions
Prazo: Post-training, approximately 8 weeks
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Participants rated how helpful they found the intervention on a 5 point scale (with 1 being very unhelpful and 5 being very helpful).
Acceptability was defined a priori of achieving a mean rating of >3.5 on the 5 point scale for helpfulness.
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Post-training, approximately 8 weeks
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Percent Medication Adherence Across All Antiretroviral Medications
Prazo: Baseline; post-training, approximately 8 weeks
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0% indicates no doses of medications were taken, and 100% means all doses were taken.
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Baseline; post-training, approximately 8 weeks
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Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)
Prazo: Baseline; post-training, approximately 8 weeks
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The RAB is a standardized survey.
Scores range from 0 to 18, with higher scores meaning greater sexual risk.
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Baseline; post-training, approximately 8 weeks
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Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology
Prazo: Baseline; post-training, approximately 8 weeks
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The Timeline Followback Method involves asking subjects to retrospectively estimate their cocaine use 30 days prior to the interview date.
Responses therefore range from 0 to 30 days.
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Baseline; post-training, approximately 8 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Christina S. Meade, PhD, Duke University
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)
1 de março de 2017
Conclusão Primária (Real)
23 de fevereiro de 2019
Conclusão do estudo (Real)
23 de fevereiro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
16 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de setembro de 2016
Primeira postagem (Estimativa)
21 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de outubro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de outubro de 2019
Última verificação
1 de outubro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Pro00053630_1
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
Sim
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