Improving Adherence and Cognition in Substance-Using HIV Patients

描述(申请人提供)：神经认知功能障碍仍然是许多艾滋病毒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。物质滥用障碍(SUD)是临床上最重要的艾滋病毒共病之一，对治疗依从性和长期结果产生负面影响。组织、计划和其他关注和执行职能经常受到影响，这反过来又对健康维护行为产生不利影响，包括治疗依从性。因此，迫切需要旨在改善患有肥胖症的艾滋病毒感染者的认知技能的治疗。基于网络的活力思维4.0(VM)认知增强计划为这一问题提供了一个独特的新解决方案，也是本项目的重点。VM4.0是为患有SUD的艾滋病毒患者定制的，由认知练习和组织工具组成，旨在增强患有SUD的艾滋病毒感染者的注意力执行技能。VM4.0结合了计算机化系统的使用，以促进治疗的依从性和增强的注意力执行技能。VM有几个带有网络交互用户界面的软件模块，并包含大脑练习和组织工具，如提醒和治疗依从性监视器。此外，它还增加了一个新颖的个性化方面，以增加实现更好治疗结果的动机。活力心灵4.0提供了一种综合的治疗方法，结合了认知补救和认知调节。使用当前软件和计划的个性化模块的屏幕截图从9名接受SUD治疗的患者收集的初步可接受数据产生了对计划中的开发的一致赞同。我们建议进行两个阶段的研究。在第一阶段，我们将进行治疗干预，将接受VM治疗的患者组(n=25)与未治疗患者的标准护理对照组(n=25)进行比较。所有参与者都将接受临床、神经认知、实验室测量的基线评估，并接受全面的SUD评估。VM将接受为期12周的VM计划培训，而对照组将接受标准护理，两组都会在过去一周收到每周电话，以监测他们的HAART和娱乐药物使用情况。在此期间，将通过自动在线数据采集以及演习表现来监测虚拟机使用的持续时间和频率。基线评估将在12周时重复，以确定标准神经认知任务的表现是否有所改善(转移)，以及这些技能是否概括为增加HAART的依从性。参与者将在6个月的随访中接受重新评估，以检查接受VM治疗的患者继续使用该计划并保持先前成果的程度。组间的显著差异将使VM方法作为一种易于使用和低成本的干预措施得到验证，有可能为患有SUD的艾滋病毒感染者提供显著的功能益处，为更大规模的有效性试验提供理由。 公共卫生相关性：迫切需要旨在提高注意力和执行职能技能的治疗，以便最终提高艾滋病毒和药物滥用障碍患者管理其健康的能力，并充分遵守HAART和其他治疗要求。基于网络的活力思维4.0(VM)认知增强计划为这一问题提供了一个独特的新解决方案，也是本次开发项目和研究调查的重点。这项拟议研究的目的是最终确定用于这一人群的VM计划的开发，并测试其在12周治疗后改善认知功能和HAART依从性的有效性，并在6个月内保持这些进展。

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.