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，以增加艾滋病毒/艾滋病患者样本的能量，活动水平和目标实现，他们的临床表现问题是明显的疲劳和未实现的职业目标。根据我们最近完成的莫达非尼的RCT和正在进行的莫达非尼的RCT，我们发现许多患者即使通过药物恢复了精力，也没有达到预期的目标。为了解决这一目标实现的失败，我们将开发和试点一种行为干预，最初基于Lejuez等人的抑郁症行为激活治疗，并由Daughters博士修改为“能量和生产力行为激活计划，或‘BA- PEP’”。该干预措施将针对那些感到严重疲劳的患者，以及那些想要工作或接受与工作相关的培训或教育的患者，一旦他们的精力在阿莫达非尼治疗后得到改善。它旨在最终在艾滋病毒诊所以及具有工作发展计划的社区机构中实施。干预发展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，与提供者的焦点小组，项目咨询委员会和一个单独的工作组。他们的意见将用于修改我们的BA-PEP干预，以促进每位患者选择的工作相关目标的实现，一旦使用阿莫达非尼改善疲劳，并进一步适应注意控制支持咨询干预。有了这些信息，我们将对12名对氨达非尼有反应的患者进行BA-PEP的探索性研究。在进一步修改后，我们将对30名对阿莫达非尼有反应的患者进行可行性试验，随机分为2:1，分别接受BA-PEP或注意控制、支持性咨询。主要的行为结果是就业或上课（通过目标实现量表方法测量）。次要结果是减少逃避/增加激活（通过抑郁行为激活量表测量），增加环境相互作用（通过EROS：环境奖励观察量表测量）。最后，我们将制定培训和监督手册，以指导实施。

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.