Improving Adherence and Cognition in Substance-Using HIV Patients

提高吸毒艾滋病毒患者的依从性和认知能力

• 批准号: 8071312
• 负责人: RONALD A COHEN
• 金额: $ 32.39万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8071312
• 关键词: Address; Adherence; Affect; Alzheimer' s Disease; Anti-Retroviral Agents; Area; Attention; Behavior; Behavior Therapy; Behavioral; Brain; Chronic; Clinic; Clinical; Cognition; Cognitive; Cognitive remediation; Comorbidity; Computer software; Control Groups; Data; Dementia; Development; Development Plans; Disease; Dose; Drug usage; Effectiveness; Exercise; Feedback; Focus Groups; Frequencies; Functional disorder; Future; HIV; Health; Health Status; Home environment; Impaired cognition; Impairment; Individual; Infection; Instruction; Internet; Intervention; Investigation; Laboratories; Learning; Life; Light; Link; Maintenance; Measures; Memory impairment; Methods; Mind; Modification; Monitor; Moods; Morbidity - disease rate; Motivation; Neurocognitive; Online Systems; Outcome; Participant; Patients; Performance; Pharmaceutical Preparations; Phase; Population; Psychological Transfer; Quality of life; Randomized; Recruitment Activity; Reporting; Research Project Grants; Sampling; Solutions; Substance abuse problem; System; Testing; Therapeutic; Time; Training; Treatment Protocols; Treatment outcome; Update; Validation; Viral Load result; abstracting; clinically significant; cognitive enhancement; cognitive function; computerized; cost; data acquisition; design; effectiveness trial; efficacy trial; executive function; experience; follow-up; functional outcomes; improved; information processing; interest; mortality; novel; processing speed; programs; recreational drug use; skills; standard care; standard measure; substance abuser; tool; treatment adherence

DESCRIPTION (provided by applicant): Neurocognitive dysfunction continues to be a significant problem for many HIV-infected people, affecting functional outcome, health status and quality of life. Substance abuse disorders (SUD) are among the most clinically significant HIV co-morbidities, negatively affecting treatment adherence and long-term outcome. Organization, planning and other attention and executive functions are often affected, which in turn adversely impacts health maintenance behaviors, including treatment adherence. Accordingly there is a compelling need for treatments aimed at improving cognitive skills among HIV-infected people with SUDs. The web-based Vigorous Mind 4.0 (VM) cognitive enhancement program provides a unique new solution to this problem and is the focus of this project. VM 4.0, which has been customized for HIV patients with SUD, consists of cognitive exercises and organizational tools designed to enhance the attention-executive skills in HIV-infected people with SUD. VM 4.0 combines the use of a computerized system to promote treatment adherence and enhanced attention-executive skills. VM has several software modules with a web interactive user interface, and contains brain exercises and organizational tools such as reminders and treatment adherence monitors. Furthermore, it adds a novel personalization aspect to increase motivation for achieving better treatment outcomes. Vigorous Mind 4.0 offers an integrated approach to therapy combining cognitive remediation and cognitive accommodation. Preliminary acceptability data collected from nine patients treated for SUD using the current software and screen shots of the planned personalized modules yielded unanimous favorable endorsement of the planned development. We propose to a two phase study. In Phase I, we will conduct a treatment intervention in which we will compare a group VM treated patients (n=25) to a standard care control group of untreated patients (n = 25). All participants will be assessed at baseline on clinical, neurocognitive, laboratory measures, as well as undergo a comprehensive SUD assessment. The VM will train on the VM program for 12 weeks, while the control group will receive standard care, with both groups receiving weekly calls to monitor their HAART and recreational drug use over the past week. The duration and frequency of VM usage will be monitored during this period through automatic on-line data acquisition, along with performance on the exercises. The baseline assessment will be repeated at 12-weeks to determine whether performance on standard neurocognitive tasks improved (transfer), and whether these skills generalize to increase HAART adherence. Participants will be reassessed at a 6-month follow-up to examine the extent to which VM treated patients continue to use the program and maintain previous gains. Significant between-group difference will provide validation of the VM approach as an easy-to-use and low cost intervention that has the potential to provide significant functional benefits for HIV-infected people with SUD, providing rationale for a larger scale effectiveness trial. PUBLIC HEALTH RELEVANCE: There is a compelling need for treatments aimed at improving attention and executive functional skills, in order to ultimately enhance the ability of people with HIV and substance abuse disorders to manage their health and adequately adhere to HAART and other treatment demands. The web-based Vigorous Mind 4.0 (VM) cognitive enhancement program provides a unique new solution to this problem and is the focus of this developmental project and research investigation. The aim of the proposed study is to finalize development of the VM program for use in this population and to test its effectiveness for improving cognitive function and HAART adherence after 12 weeks of treatment and to maintain these gains over six months.

描述（由申请人提供）：神经认知功能障碍仍然是许多 HIV 感染者的一个重大问题，影响功能结果、健康状况和生活质量。药物滥用障碍 (SUD) 是临床上最显着的 HIV 合并症之一，会对治疗依从性和长期结果产生负面影响。组织、计划和其他注意力和执行功能经常受到影响，进而对健康维护行为（包括治疗依从性）产生不利影响。因此，迫切需要旨在提高患有 SUD 的 HIV 感染者的认知技能的治疗。基于网络的 Vigorous Mind 4.0 (VM) 认知增强程序为这个问题提供了独特的新解决方案，也是该项目的重点。 VM 4.0 是为患有 SUD 的 HIV 患者定制的，由认知练习和组织工具组成，旨在增强患有 SUD 的 HIV 感染者的注意力和执行能力。 VM 4.0 结合了计算机系统的使用，以促进治疗依从性和增强注意力执行技能。 VM 具有多个带有网络交互式用户界面的软件模块，并包含大脑练习和组织工具，例如提醒和治疗依从性监视器。此外，它还增加了新颖的个性化方面，以增加实现更好治疗结果的动力。 Vigorous Mind 4.0 提供了一种结合认知矫正和认知调节的综合治疗方法。使用当前软件从 9 名接受 SUD 治疗的患者收集的初步可接受性数据以及计划的个性化模块的屏幕截图获得了对计划开发的一致认可。我们建议进行两阶段研究。在第一阶段，我们将进行治疗干预，将 VM 治疗组患者 (n = 25) 与未经治疗患者的标准护理对照组 (n = 25) 进行比较。所有参与者都将在基线时接受临床、神经认知、实验室测量的评估，并接受全面的 SUD 评估。 VM 将接受为期 12 周的 VM 计划训练，而对照组将接受标准护理，两组每周都会接到电话，以监测他们在过去一周的 HAART 和消遣性药物的使用情况。在此期间，将通过自动在线数据采集以及练习表现来监控虚拟机使用的持续时间和频率。基线评估将在 12 周时重复进行，以确定标准神经认知任务的表现是否有所改善（转移），以及这些技能是否普遍适用以提高 HAART 依从性。参与者将在 6 个月的随访中接受重新评估，以检查 VM 治疗患者继续使用该计划并保持先前​​收益的程度。显着的组间差异将验证 VM 方法作为一种易于使用且低成本的干预措施，有可能为患有 SUD 的 HIV 感染者提供显着的功能益处，为更大规模的有效性试验提供依据。 公共卫生相关性：迫切需要旨在提高注意力和执行功能技能的治疗，以最终增强艾滋病毒和药物滥用障碍患者管理其健康并充分遵守高效抗逆转录病毒疗法（HAART）和其他治疗要求的能力。基于网络的 Vigorous Mind 4.0 (VM) 认知增强程序为这一问题提供了独特的新解决方案，也是该开发项目和研究调查的重点。拟议研究的目的是最终确定用于该人群的 VM 程序的开发，并测试其在治疗 12 周后改善认知功能和 HAART 依从性的有效性，并在六个月内保持这些收益。