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临床试验/NCT02909101
NCT02909101已完成不适用

Cognitive Training to Reduce Impulsivity in HIV-infected Cocaine Users

Duke University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Working Memory Assessed by Domain Deficit Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Active Cognitive Training (ACT)

Experimental

Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 8 weeks.

干预措施: Active Cognitive Training (ACT) (Device)

Control Training (CON)

Sham Comparator

Participants will complete 48 training sessions over 8 weeks. The control games are not designed to enhance memory.

干预措施: Control Training (CON) (Device)

结局指标

主要结局

Working Memory Assessed by Domain Deficit Score

时间窗: Baseline; post-training, approximately 8 weeks

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.

次要结局

  • Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions(Post-training, approximately 8 weeks)
  • Percent Medication Adherence Across All Antiretroviral Medications(Baseline; post-training, approximately 8 weeks)
  • Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)(Baseline; post-training, approximately 8 weeks)
  • Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)(Baseline; post-training, approximately 8 weeks)
  • Acceptability as Measured by Participant Ratings(Post-training, approximately 8 weeks)
  • Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology(Baseline; post-training, approximately 8 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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