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.
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.