Improving Adherence and Cognition in Substance-Using HIV Patients

描述（由申请人提供）：神经认知功能障碍仍然是许多HIV感染者的一个重要问题，影响功能结局、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合并症之一，对治疗依从性和长期结局产生负面影响。组织、计划和其他注意力和执行功能经常受到影响，这反过来又会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）认知增强计划为这个问题提供了一个独特的新解决方案，也是这个项目的重点。VM 4.0是为HIV感染者定制的，包括认知练习和组织工具，旨在提高HIV感染者的注意力执行技能。VM 4.0结合了计算机化系统的使用，以促进治疗依从性和增强注意力执行技能。VM有几个软件模块，带有网络交互式用户界面，并包含大脑练习和组织工具，如提醒和治疗依从性监测器。此外，它还增加了一个新的个性化方面，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补救和认知调节的综合治疗方法。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治疗的患者中收集的初步可接受性数据对计划的开发产生了一致的有利支持。我们建议进行两阶段研究。在I期，我们将进行治疗干预，其中我们将比较VM治疗患者组（n=25）与未治疗患者的标准治疗对照组（n = 25）。所有受试者将在基线时接受临床、神经认知、实验室指标评估，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，两组每周都会接到电话，以监测他们在过去一周内的HAART和娱乐性药物使用情况。在此期间，将通过自动在线数据采集，沿着监测虚拟机使用的持续时间和频率以及演习的执行情况。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改善（转移），以及这些技能是否普遍增加HAART依从性。参与者将在6个月随访时重新评估，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。显著的组间差异将验证VM方法作为一种易于使用和低成本的干预措施，有可能为患有SUD的HIV感染者提供显著的功能获益，为更大规模的有效性试验提供依据。 公共卫生相关性：迫切需要旨在改善注意力和执行功能技能的治疗，以最终提高艾滋病毒和药物滥用障碍患者管理其健康并充分坚持高效抗逆转录病毒疗法和其他治疗需求的能力。基于网络的Vigorous Mind 4.0（VM）认知增强计划为这个问题提供了一个独特的新解决方案，也是这个发展项目和研究调查的重点。拟议研究的目的是完成VM计划的开发，用于该人群，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6个月内保持这些收益。

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.