Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

描述（由申请人提供）：我们提出了一个综合的药物/行为干预计划，以增加能量，活动水平和目标的实现与艾滋病毒/艾滋病的人的样本，其目前的问题是临床上显着的疲劳和未满足的职业目标。基于我们最近完成的莫达非尼随机对照试验和正在进行的阿莫达非尼随机对照试验，我们发现许多患者即使通过药物恢复能量也无法达到预期目标。为了解决这种目标实现的失败，我们将开发和试点行为干预，最初基于Lejuez等人的抑郁症行为激活治疗，Daughters博士将其修改为“能量和生产力行为激活计划，或'BA-PEP'”。干预将对经历显著疲劳的患者进行，并且一旦他们的精力通过阿莫达非尼治疗得到改善，他们希望工作或接受与工作相关的培训或教育。它的目的是最终在艾滋病毒诊所以及具有工作发展方案的社区机构实施。 干预措施的制定包括形成性工作和试点研究。形成性工作包括深入的患者访谈，与供应商的焦点小组，项目咨询委员会和一个单独的工作组。他们的输入将被用来修改我们的BA-PEP干预，以促进实现由每个患者选择的工作相关的目标，一旦疲劳已经改善与阿莫达非尼，并进一步适应注意力控制支持咨询干预。 根据这一输入，我们将使用BA-PEP对12名对阿莫达非尼有反应的患者进行探索性研究。在进一步修改后，我们将进行一项可行性试验，其中30名对阿莫达非尼有反应的患者以2：1的比例随机分配到BA-PEP或注意力控制，支持性咨询。主要的行为结果是就业或上课（通过目标达成量表方法测量）。次要结果是减少回避/增加激活（通过抑郁症行为激活量表测量）和增加环境相互作用（通过EROS：环境奖励观察量表测量）。最后，我们将编制培训和监督手册，以指导执行工作。 公共卫生相关性：疲劳在艾滋病毒阳性群体中很普遍，是实现生产性和有意义生活的重大障碍，包括工作，学校和职业培训。我们已经证明，疲劳的药物治疗可以恢复能量，促进日常活动的增加，但单独使用通常不足以实现更复杂的目标，如恢复工作。我们提出了一个综合干预与armodafinil和行为激活计划，为那些改善能源，以促进目标的实现，使患者能够工作，志愿者或上学，从而不仅有助于他们的个人生活质量，但提高社区以及，同时提供了一个模型，为未来的应用在社区设置。

DESCRIPTION (provided by applicant): We propose an integrated medication/behavioral intervention program to increase energy, activity level and goal attainment in a sample of people with HIV/AIDS whose presenting problem is clinically significant fatigue and unmet vocational goals. Based on our recently completed RCT of modafinil and ongoing RCT of armodafinil, we found that many patients fail to achieve desired goals even though energy is restored by medication. To address this failure of goal attainment, we will develop and pilot a behavioral intervention, originally based on Behavioral Activation Treatment for Depression of Lejuez et al., and modified by Dr. Daughters as "Behavioral Activation Program for Energy and Productivity, or 'BA- PEP'". The intervention will be conducted with patients who experience significant fatigue, and who want to work or get work-related training or education once their energy improves with armodafinil treatment. It is intended for eventual implementation in HIV clinics as well as community agencies with work development programs. The intervention development includes both formative work and pilot studies. The formative work comprises in-depth patient interviews, focus groups with providers, a Project Advisory Board, and a separate Work Group. Their input will be used to modify our BA-PEP intervention to promote achievement of work-related goals selected by each patient, once fatigue has been ameliorated with armodafinil, and to further adapt the attention control supportive counseling intervention. With this input, we will conduct an exploratory study using BA-PEP with 12 patients responsive to armodafinil. After further modifications, we will conduct a feasibility trial with 30 armodafinil-responsive patients randomized 2:1 to BA-PEP or an attention control, supportive counseling. The main behavioral outcome is employment or taking classes (measured by Goal Attainment Scaling methodology). Secondary outcomes are reduced avoidance/increased activation (measured by the Behavioral Activation for Depression Scale), and increased environmental interactions (measured by the EROS: Environmental Rewards Observation Scale). Finally, we will develop training and supervision manuals to guide implementation. PUBLIC HEALTH RELEVANCE: Fatigue is widespread in the HIV+ community, and is a significant barrier to achieving a productive and meaningful life including work, school and vocational training. We have shown that pharmacologic treatment of fatigue can restore energy, and promote increases in daily activities but alone is not usually sufficient to achieve more complex goals such as returning to work. We propose an integrated intervention with armodafinil and a behavioral activation program for those with improved energy to promote goal attainment and enable patients to work, volunteer or attend school, thus not only contributing to their personal quality of life but enhancing the community as well, while providing a model for future application in community settings.