Behavioral Activation/Armodafinil to Treat Fatigue in HIV/AIDS

描述(由申请人提供)：我们提出了一项综合药物/行为干预计划，以提高HIV/AIDS患者的能量、活动水平和目标实现程度，这些患者的临床问题是严重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随机对照试验和正在进行的阿莫达非尼的随机对照试验，我们发现，即使通过药物恢复能量，许多患者也无法达到预期的目标。为了解决这一目标实现的失败，我们将开发和试验一种行为干预，最初基于Lejuez等人的行为激活治疗抑郁症，并由Daughters博士修改为“能量和生产力行为激活计划，或‘BA-PEP’”。干预将在经历严重疲劳的患者中进行，这些患者希望在阿莫达非尼治疗后精力改善后工作或接受与工作相关的培训或教育。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先导性研究。形成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干预措施，以促进每个患者选择的工作相关目标的实现，一旦阿莫达非尼改善了疲劳，并进一步调整注意力控制支持性咨询干预。在此基础上，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，我们将对30名阿莫达非尼有反应的患者进行可行性试验，这些患者随机分为BA-PEP组或注意力对照、支持性咨询组。主要的行为结果是就业或参加课程(通过目标实现程度衡量方法衡量)。次要结果是减少回避/增加活跃(通过抑郁行为激活量表衡量)，以及增加环境相互作用(通过EROS：环境奖励观察量表衡量)。最后，我们将制定培训和监督手册，以指导执行。 与公共卫生相关：疲倦在艾滋病毒感染人群中普遍存在，是实现包括工作、学校和职业培训在内的富有成效和有意义的生活的重大障碍。我们已经证明，药物治疗疲劳可以恢复能量，促进日常活动的增加，但通常不足以实现更复杂的目标，如重返工作岗位。我们建议对阿莫达非尼进行综合干预，并为那些精力得到改善的人提供行为激活计划，以促进目标的实现，使患者能够工作、志愿或上学，从而不仅有助于提高他们的个人生活质量，还可以增强社区，同时为未来在社区环境中的应用提供一个模式。

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.